European Journal of Oncology Nursing 19 (2015) 182e190
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European Journal of Oncology Nursing journal homepage: www.elsevier.com/locate/ejon
Feasibility of psychoeducational interventions in managing chemotherapy-associated nausea and vomiting (CANV) in pediatric oncology patients Carmen W.H. Chan a, *, Lai Wah Lam a, Chi Kong Li b, Jeanny S.S. Cheung b, Karis K.F. Cheng c, Ki Wai Chik b, Helen Y.L. Chan a, Winnie K.W. So a, Winnie P.Y. Tang a a b c
Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong Department of Paediatrics, Prince of Wales Hospital, Hong Kong National Singapore University, Hong Kong
a b s t r a c t Keywords: Oncology Pediatric Nausea Vomiting Chemotherapy Psychoeducation intervention
Purpose: Childhood cancer patients often suffer from Chemotheraphy-Associated Nausea and Vomiting (CANV). To alleviate CANV, relaxation techniques and patient education were combined to develop a multidimensional psychoeducational intervention package. The aim of this pilot study was to assess the feasibility of the two major components, namely, (1) relaxation, and (2) patient education, of a psychoeducational intervention, prior to the commencement of the main study. Methods: A pre-testepost-test control group design was adopted. Twenty patients were allocated equally to the relaxation group (10 participants) and to the educational group (10 participants). Twenty historical matched control cases were identified to form the control groups. Besides, a process evaluation was adopted to assess the feasibility of the study. Results: In relation to episodes of vomiting on day 3, a significant difference was detected from the results (X2 ¼ 8.54, p ¼ 0.036), in that fewer patients in the relaxation group experienced vomiting. A significant difference was not found in both the use of antiemetics and body weight between the groups. All subjects in the intervention groups adhered to the intervention and completed the questionnaire without difficulty. Patients and parents perceived the intervention as being moderately useful. Conclusions: Although the beneficial effect of relaxation and education in alleviating CANV was not wellsupported statistically, the findings from descriptive data suggest that these interventions promoted the intake of antiemetics as a preventive method. Both interventions and instruments were well-received by the patients and also by their parents. © 2014 Elsevier Ltd. All rights reserved.
Introduction In the treatment of childhood malignancies, intensive chemotherapy (CT) regimens are often used. In general, they are more emetogenic compared to those used in adults (Chan et al., 2007). CANV normally appears one to 2 h after CT has started and it then persists for six to 12 h or even for a few days post the CT cycle (Molassiotis et al., 2002; Chan et al., 2003). Limited studies were carried out on the management of CANV in children, and a majority of the existing literature places an emphasis on pharmacological intervention.
* Corresponding author. E-mail address: [email protected] (C.W.H. Chan). http://dx.doi.org/10.1016/j.ejon.2014.09.002 1462-3889/© 2014 Elsevier Ltd. All rights reserved.
The immediate adverse effects of CANV in young children include dehydration, electrolyte imbalance, and weight loss (Keller, 1995). Later problems can follow; these are, for example, an increased susceptibility to infections and a decreased renal elimination of drugs (Joss et al., 1990). Without the proper initial control of CANV, the development of conditioned nausea and vomiting, avoidance of care, patients' self-deprecation, and even a refusal of CT can be found in pediatric patients, together with parental anxiety (Chan et al., 2007). Because children with CANV often experience changing preferences towards food, the odors or colors that are particular to the ward can nauseate them (Hockenberry-Eaton and Benner, 1990). It has been reported that CANV is significantly correlated with motion sickness, the child's anxiety, and parental anxiety (Chan et al., 2007). This may seriously compromise the
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quality of life of pediatric patients suffering from CANV (Li et al., 2010). Theoretical framework Nausea and vomiting result from the stimulation of the vomiting center in the brain (Fessele, 1996). This can happen through the following four pathways: (a) the cerebral cortex and limbic system; (b) the vestibular system; (c) the chemoreceptor trigger zone; and (d) the afferent vagal and visceral nerves. Despite the growing availability of more potent antiemetics every year, the efficacy of these drugs is not guaranteed to all patients and no single drug can be effective against CANV which results through multiple pathways (Fessele, 1996; Holdsworth et al., 1995). A hypothesis is proposed that multi-dimensional intervention is more effective provided that more than one pathway is blocked (Fig. 1). Preventive measures for chemotherapy-naïve patients are regarded as the most effective treatment because the severity of CANV may increase with time (Chan et al., 2007). Founded on the theoretical framework of the neural pathways involved in transmitting emetic stimuli (Fessele, 1996), the authors have developed a multi-dimensional psychoeducational program which combines the use of relaxation techniques and patient education (Chan and Thompson, 2006; Chan et al., 2011; Fessele, 1996; Keller, 1995) (Fig. 1). Relaxation works by blocking the cerebral cortex pathway whereas patient education emphasizing risk assessment, the use of antiemetics, and meal preparation works by blocking the remaining three pathways. Although it sounds logical to block all the pathways of emetic stimuli by adopting a comprehensive program, every major component of the program has to be examined individually in an exploratory trial to ascertain its effect (Chan and Thompson, 2006). Most studies have reported that psychoeducational interventions are effective in treating CANV in adults (Arakawa, 1997; Molassiotis et al., 2002; Redd et al., 2001). Other effects reported are the reduction of negative emotions and physiological arousal, and an improvement in caloric intake and greater satisfaction with the care received (Burish and Tope, 1992). Among these psychoeducational interventions, relaxation techniques are the most widely researched; they include the combined use of progressive muscle
Reducing anxiety by PMR and GI
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relaxation (PMR) and guided imagery (GI) (Chan et al., 2011). As defined, PMR is the progressive tensing and relaxing of successive muscle groups, and GI is a technique which uses a favorable and relaxing mental image to distract an individual's attention from the distressful side of the CT administration (Snyder and Lindquist, 2002). It has been reported that nurses can successfully deliver PMR and GI to cancer patients and receive favorable responses (Chan et al., 2011, 2012; Molassiotis et al., 2002). Young children undergoing the pre-operational and concrete operational developmental stages (aged 4e11) are more responsive to distraction and imagination and they also have the faculty of logical thought. Therefore, the PMR and GI techniques which are taught to adults can also be adopted for children as young as preschoolers (Ladas et al., 2006; Redd et al., 2001). Although the adoption of psychoeducational interventions in handling pain and general distress is frequently suggested in pediatric oncology literature (Chan, 2005; Ladas et al., 2006), the effect of such interventions on CANV has rarely been examined in children. This pilot study serves as a pioneer which explores multiple components in a comprehensive program with the ultimate aim of blocking all four emetic pathways. Aims The aim of this pilot study was to assess the feasibility of the two major components, namely, (1) relaxation, and (2) patient education, of a psychoeducational intervention, prior to the commencement of the main study. The objectives of this pilot study were as follows: (1) to estimate the effect size of relaxation and patient education on the reduction and occurrence of CANV, improvement in the use of antiemetics, calorie intake, body weight, anxiety, satisfaction with care, and performance status; (2) to assess the feasibility of the study design, including recruitment, implementation of intervention, and measurement of outcomes, by process evaluation; and (3) to evaluate the suitability of using the instruments the Morrow Assessment of Nausea and Emesis (MANE) (Morrow, 1992) and the Chinese version of A-State scale of the StateTrait Anxiety Inventory (STAI) (Tsoi et al., 1986) in children
Cerebral cortex pathway (related to mood, feeling, and emotion)
Chemoreceptor trigger zone (related to chemical signals from the bloodstream)
Advice on and support for the use of antiemetics
Stimulation of vomiting center
Advice on risk factors, e.g., motion sickness
Vestibular system (related to motion sickness)
Afferent vagal and visceral nerves (related to gastrointestinal irritation or distension)
Advice on meal preparation
Remarks: PMR: progressive muscle relaxation; GI: guided imagery. Fig. 1. Theoretical rationale supporting the relationship between CANV and proposed intervention. PMR: progressive muscle relaxation; GI: guided imagery.
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(2) having advanced-stage cancer.
aged 4 to11 by assessing the level of completeness of these instruments.
Materials and methods Design This pilot study was an exploratory trial using a pre-testeposttest control group design. Process evaluation was also adopted to assess the feasibility, acceptance and appropriateness of the study. Setting and participants The research assistant (RA) recruited a total of 20 patients and their parents from the pediatric oncology unit of a publicly-funded hospital in Hong Kong. The most common age of the patients receiving treatment at the participating hospital was 5.4-years-old and there were about 25e30 eligible participants per year. The inclusion criteria of patient participants were as follows: (1) (2) (3) (4) (5)
aged 4e11; diagnosis of cancer and receiving CT; chemotherapy-naïve; able to understand Chinese; and signed informed consent (both by patients and parents).
The exclusion criteria were as follows: (1) having brain metastasis; and/or
We formed a total of two intervention groups and two control groups. Eligible and consenting patients were randomly recruited to form Group 1 (10 participants) (the relaxation group) and Group 2 (10 participants) (the education group) by the lucky draw method (Fig. 2). Historical data, including body weight, occurrence of vomiting, and intake of antiemetics, were collected from another 20 matched control participants identified from medical records. The control participants' age, disease, and the emetogenicity of chemotherapy agents were matched with intervention participants. Group 3 was formed by ten historical control cases who matched the characteristics of the Group 1 participants, whereas the other ten historical control cases matching the characteristics of the Group 2 participants formed Group 4. Interventions The authors have developed a psychoeducational program with reference to the recommendations from existing literature (Fessele, 1996; Keller, 1995; Li et al., 2008). An expert panel of academics and clinicians has rated the program as relevant and appropriate. It consists of two major components: relaxation, and patient's education. Patients in Group 1 received six sessions of daily PMR and GI training (day 0 to day 5) (30 min/session), as recommended by Chan et al. (2011) and Molassiotis et al. (2002), and daily selfpractice of the skill for a period of two months. Participants were provided with a PMR and GI audiotape.
Assessed for eligibility (n = 75)
Enrollment
Excluded (n = 10) Declined to participate (n = 45)
Randomized (n = 20)
Allocated to PMR group (n = 10) Received allocated intervention (n = 10 ) Did not receive allocated intervention (n = 0)
Allocation
Allocated to education group (n = 10) Received allocated intervention (n = 10) Did not receive allocated intervention (n = 0)
Lost to follow-up from day 0–day 60 (n = 0) Discontinued intervention (n = 0)
Follow-up
Lost to follow-up from day 0–day 60 (n = 0) Discontinued intervention (n = 0)
Analysis
Included in PMR group analysis (n = 10)
Included in PMR group analysis (n =10)
Fig. 2. Consolidated standards of reporting trails (CONSORT) flowchart.
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Patients in Group 2 received two sessions of patients/parents education (on day 0 and day 2) (30 min per session); this focused on risk assessment, antiemetics use and meal planning. Details are shown in Appendix A. Parents were invited to participate as co-learners and supporters in both of the intervention groups. They also encouraged and assisted the young children to respond to the questionnaire. An RA with two years of pediatric nursing experience delivered the intervention. The RA underwent a two-day training program; this focused on communication skill, latest cancer treatment and side-effects, and the practice of PMR and GI. The usual care of the participating patients (including the control subjects) in the ward involves antiemetic Ondansetron intravenously on a need base and the usual diet advice focusing on avoiding spicy and greasy food. Recommended food should be easily swallowed and digested. Participants in both of the intervention and control (historical data) groups received this usual care. Outcome measures Primary outcome measures: occurrence of nausea and vomiting. Secondary outcome measures: use of antiemetics, anxiety (child and parent), physiological indices (caloric intake, changes in body weight), performance status, satisfaction with care (child and parent). Process evaluation data Self-rating of the usefulness of intervention (child and parent), activity log, and daily PMR and GI practice. Instruments Instruments 1 to 8 were used to estimate the effect size of the tested interventions. Nausea and vomiting The MANE (Morrow, 1992) was used to measure the occurrence, intensity and the duration of CANV. A higher score indicates more severe CANV. The mean testeretest reliability coefficients of MANE ranged from 0.72 to 0.96 across different studies. A Chinese version of the scale was translated by Molassiotis et al. (2002) and it tested as valid and reliable. It has been further tested by the research team in 15 eligible child cancer patients (aged 6e18) with a testeretest reliability of 0.82e0.9. These children did not report any difficulty in answering the questions. Its appropriateness for children aged 4 to 11 was pilot-tested in this study. Anxiety The Chinese version of the A-State scale of the State-Trait Anxiety Inventory (STAI) (Tsoi et al., 1986) was used to assess the state of anxiety of the parents. The A-State scale consists of 20 items for measuring the immediate feelings of apprehension, nervousness and worry. A higher score indicates more severe anxiety. An internal consistency of 0.92 has been reported in the Chinese version of A-State scale (Ismail et al., 2010). The Chinese version of the Children STAI A-State scale was selected to assess the anxiety of pediatric patients (Li and Lopez, 2004; Li et al., 2008). The testeretest reliability coefficients for the Chinese children A-State scale were 0.80 and 0.78, and internal consistencies ranged from 0.84 to 0.94 in studies of patients with different age groups. Criterion-related validity was confirmed by
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positive correlation of the Chinese A-State scale with children's heart rate (r ¼ 0.49) and mean blood pressure (r ¼ 0.40). The construct validity of the scale was confirmed by administering the scale to 237 primary school students (aged 6e12) in Hong Kong. Usage of antiemetics This was obtained from the medical record of the actual use of the antiemetics. History of motion sickness This history was obtained from interviewing parents and patients, and it was then verified by reference to medical records. Physiological indices Pulse rate and blood pressure (for Group 1 only) was recorded 15 min before and after each PMR and GI session to assess the immediate physiological relaxation effects. Caloric intake was collected by asking parents and patients (of both Groups 1 and 2) to maintain an accurate food diary of the patients' intake of all foods and fluids. The RA calculated the caloric value of each food item in accordance with the Growth Standard of Southern Chinese published by the Department of Pediatrics, The Chinese University of Hong Kong (Leung, 1996). Daily body weight Body weight was measured daily before breakfast at 7 or 8 a.m. For the patients who had been discharged home, their parents followed our instructions to collect daily body weight before breakfast. Satisfaction with care Patients' and parents' satisfaction with their care during the intervention period was examined by a self-reported 4-point likert scale; this indicates “extremely unsatisfactory” (0) to “extremely satisfactory” (3). Self-reporting likert scales are commonly used as a tool to assess satisfaction levels. Performance status Patients' performance status was assessed by the Play Performance Scale for Children (Lansky et al., 1985). The scale is a simple score of 0e100, checked by the RA. A higher score indicates better performance. The scale has been validated in the participating hospital with pediatric oncology patients aged 1 to 16. The major roles of children focus on play, and therefore play is adopted as the yardstick of performance. Changes in a child's performance are generally accepted as an aid to evaluate the efficacy of treatment and a child's quality of life (Lansky et al., 1985). Items 9, 10, and 11 hereunder were used to measure the process outcomes. Intervention activity log The authors have set up an intervention activity log to evaluate the process of intervention delivery. In each session, the RA used the activity log to record problems encountered during the implementation of the interventions. The comments and concerns raised by the participants about the interventions were recorded. The RA also checked the patients' actual time spent on the
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intervention and the participation levels, such as their attention span and their ability to demonstrate the PMR and GI. Self-rating of the usefulness of intervention The patients' and parents' self-rating of the usefulness of each intervention component was assessed by a 6-point likert scale; this indicates “extremely useful” (5) to “not at all useful” (0). Practice of PMR and GI Parents and patients in intervention Group 1 were required to keep a simple health diary to record the patient's self-practice of PMR and GI for a period of two months. Procedures Appendix B shows a flow chart of the procedure and data collection period. All consenting participants completed a whole set of instruments at baseline and at seven days after CT was implemented, with eight days' measurements in total. This data collection schedule was recommended in previous studies to assess the acute and delayed CANV (Arakawa, 1997; Molassiotis et al., 2002). Longterm data collected at the end of one month and two months, respectively, were performance status, anxiety, compliance with PMR and GI (Group 1 only), and satisfaction with care. Generally, two cycles of CT were covered in this two-month data collection period. Data collection and interventions were carried out either at the patient's home or on the ward (where more feasible); this was because most of the patients were discharged home at day 2 to day 3 after CT was completed. In 20 matched control participants, historical data, including body weight, occurrence of vomiting, and intake of antiemetics, were collected from the medical records. The control participants' age, disease and emetogenicity of the chemotherapy agents were matched with intervention participants by the RA. All these data were objective in nature and easily traced from the patients' medical records. Data analysis Chi-square, ManneWhitney U tests and Kruskal Wallis tests were used to compare the characteristics and outcomes of participants between the intervention and the control groups. Withingroup comparisons were done by the use of Friedman tests. Results We approached 65 patients who met the eligibility criteria and 20 of them consented to participate in the study, yielding a response rate of 30.7%. Despite the low response rate, none of the recruited patients withdrew throughout the 60 days of the data collection period. Baseline characteristics of the study sample The age of study participants ranged from 4 to 11 years old, with the mean age of 8.6 years old. The majority of them (n ¼ 20) suffered from lymphocytic leukaemia, followed by osteosarcoma (n ¼ 12). No participant had experienced vomiting immediately after CT at baseline (day1). To analyze the baseline characteristics of participants between the intervention and control groups at day 0, Chi-square and Kruskal Wallis tests were used. No difference was found in their diagnoses, age, and body weight at baseline.
To compare the baseline outcome measures between the two intervention groups, Chi-square and ManneWhitney U tests were used. The results showed that patients in Group 1 had significantly lower levels of child anxiety (Z ¼ 2.14, p ¼ 0.032) at baseline. Parents of patients in Group 1 also had a lower mean score of anxiety, but it is not statistically significant. Regarding other demographic and clinical variables, no difference was found. Outcome evaluation from day 0 to day 7 Comparison between intervention groups and control groups The body weight, occurrence of vomiting, and the use of antiemetics between the intervention and control groups was compared by Kruskal Wallis tests and Chi-square tests. Withingroup changes were tested by Friedman tests. Because the historical control groups did not have data on the severity and duration of vomiting, only the occurrence was reported here for comparison. Table 1 shows the comparison of body weight from day 0 to day 7. No significant difference (p > 0.05) was detected between the groups at each data collection time. All groups experienced a slight decrease in body weight (less than 1 kg) over the eight-day period. Significant within-group changes in body weight were found in Group 2 only (p ¼ 0.01). Due to the small sample size, the research team was unable to compare changes over time between the groups. A significant difference in the occurrence of vomiting after the commencement of CT was detected only on day 3 (Pearson Chi Square ¼ 8.54, p ¼ 0.036), thereby indicating that fewer patients in the relaxation group (Group 1) experienced vomiting (Table 2). Descriptive data show that on day 0, none of the patients in the control groups took antiemetics. On day 2, more patients in the control groups than those in the intervention groups took antiemetics. On the other hand, more patients in the intervention groups took antiemetics on day 0 and day 1, and subsequently fewer patients in these groups took antiemetics from day 2 onwards. Comparison between the relaxation group and the education group There were no statistical differences in body weight, the occurrence of nausea and vomiting, the intake of antiemetics, and anxiety level (p > 0.05) between the two intervention groups (Tables 1e3). Both Groups 1 and 2 had significant within-group changes in parent anxiety levels (Group 1 at p ¼ 0.005, Group 2 at p ¼ 0.001), in that the parents' levels of anxiety decreased over time from day 0 to day 60. However, the with-group changes in the children's anxiety level were not significant in both Groups 1 and 2 (Table 3). There was no significant difference in the children's performance status and the parents' satisfaction with care between the Table 1 Body weight of each study group from day 0eday 7 (in kg). Group Gp 1 Gp 2* Gp 3 Gp 4 Total
Mean SD Mean SD Mean SD Mean SD Mean SD
Day 0
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
37.93 16.52 41.29 14.63 40.83 19.16 45.19 17.37 41.31 16.54
38.29 16.96 41.65 14.80 40.99 19.57 44.88 17.64 41.45 16.81
38.08 16.97 41.51 14.96 40.87 19.39 44.85 17.52 41.32 16.78
37.69 16.57 41.18 14.59 40.49 19.28 44.66 17.57 41.00 16.61
37.54 16.38 40.82 14.40 40.31 19.22 44.56 17.60 40.80 16.52
37.80 16.30 41.02 14.30 40.14 19.26 44.49 17.71 40.86 16.50
37.49 15.97 40.95 14.40 40.24 19.33 44.30 17.65 40.74 16.46
37.43 15.76 40.93 14.19 40.20 19.10 44.28 17.44 40.71 16.26
*significance level at p < 0.05. Gp 1: relaxation group. Gp 2: education group. Gp 3: historical controls that matched the characteristics of Group 1. Gp 4: historical controls that matched the characteristics of Group 2.
C.W.H. Chan et al. / European Journal of Oncology Nursing 19 (2015) 182e190 Table 2 Number of patients in each group who had experienced nausea, vomiting and the intake of antiemetics from day 0eday 7.
Intake of antiemetics
Nausea before CT Vomiting before CT *Vomiting after CT
Nausea after CT
Group
Day 0
Day 1
Day 2
*Day 3
Day 4
Day 5
Day 6
Day 7
Gp Gp Gp Gp Gp Gp Gp Gp Gp Gp Gp Gp Gp Gp
5 7 0 0 1 1 5 3 0 0 0 0 0 0
5 6 3 4 1 3 0 0 0 0 1 0 2 5
4 3 8 10 2 4 1 3 2 3 3 7 5 6
2 5 3 3 3 6 2 5 4 7 6 10 4 8
1 4 2 3 2 6 1 3 3 7 7 6 4 8
1 4 1 3 2 4 1 1 2 1 5 6 4 8
0 0 1 1 3 2 1 1 2 2 6 5 5 4
1 0 0 0 3 2 2 1 4 1 5 5 6 6
1 2 3 4 1 2 1 2 1 2 3 4 1 2
*significance level at p < 0.05. Gp 1: relaxation group. Gp 2: education group. Gp 3: historical controls that matched the characteristics of Group 1. Gp 4: historical controls that matched the characteristics of Group 2.
relaxation group (Group 1) and the education group (Group 2). There was a trend that the children's performance status was lower at day 3 to day 30 than the rest of data collection period in both groups. There was no significant difference in calorie intake between the relaxation group and the education group. There was a trend that patients in both groups had their lowest calorie intake at day 2 to day 3. Their calorie intake gradually improved from day 4 to day 7 (Table 4). A Friedman test showed that the within-group changes of calorie intake in Group 2 were significant (p ¼ 0.001), with a drastic reduction in day 2 to day 3. Process evaluation As revealed by data collected from the intervention log, the patients in the relaxation group demonstrated a high attention to coaching, and a high ability to follow instructions and to perform returned demonstration with most of them staying full-time in the sessions. Meanwhile, the education group also demonstrated a high attention during the education session. Nevertheless, their level of
Table 3 Level of parent anxiety and child anxiety between the relaxation group (Group 1) and education group (Group 2) from day 0eday 60. Group
Parent anxiety (20e80)
Day 0
Day 3
Day 7
Day 30
Day 60
Gp 1**
Mean Std deviation Mean Std deviation Mean Std deviation
55.00 9.447 62.33 10.642 58.67 10.466
53.20 10.497 62.00 9.684 57.60 10.816
46.10 13.059 49.50 8.343 47.80 10.807
54.10 8.582 54.00 6.342 54.05 7.345
47.10 6.590 46.30 9.381 46.70 7.901
Gp 2*** Total Group
Child anxiety (20e80)
Day 0*
Day 3
Day 7
Day 30
Day 60
Gp 1
Mean Std deviation Mean Std deviation Mean Std deviation
41.60 7.043 49.00 6.481 45.30 7.603
45.40 8.249 48.20 7.131 46.80 7.641
47.00 7.180 47.60 5.985 47.30 6.441
44.20 7.084 46.20 7.146 45.20 7.001
43.10 6.557 46.30 7.959 44.70 7.284
Gp 2 Total
*significance level at p < 0.05. **significance level at p < 0.01. *** significance level at p < 0.001.
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Table 4 Calorie intake of the relaxation group and education group from day 0eday 7. Group Gp 1 (n ¼ 10) Gp 2* (n ¼ 10) Total (n ¼ 20)
Day 0 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Mean 1894 SD 795 Mean 2155 SD 760 Mean 2024 769
1328 678 1476 775 1402 713
1213 1203 801 515 1007 925
1147 737 804 658 976 703
1473 1177 1333 1133 1403 1126
1642 987 1479 859 1560 905
1682 1200 1748 950 1715 1054
1495 649 1632 464 1567 547
*significance level at p < 0.05.
interest and participation during discussions were moderate and they tended not to ask for further information. According to the results from the health diaries, a majority of the patients practiced PMR three or four times per week at home. This indicated a moderate compliance towards PMR self-practice. Regarding blood pressure or pulse after the practice of PMR, ManneWhitney tests did not detect a significant change. Patients' and parents' perceived usefulness of the interventions were moderately useful. A ManneWhitney U test detected a significant difference only in the day 1 anxiety reduction of parents (Z ¼ 0.314, P ¼ 0.032), thereby indicating that they perceived PMR to be a more useful practice in anxiety reduction. A trend was observed that the overall “usefulness of intervention” scores in the relaxation group were higher in comparison with those in the education group. Discussion The first objective was to make an estimate of the effect size of relaxation and patient education, as used in managing CANV among pediatric cancer patients. Due to the small sample size and the use of non-parametric tests, the findings were not confirmatory in most comparisons, and therefore they could not fulfill the objective. However, a significant reduction in vomiting as a possible result of the effect of relaxation was reported at day 3, the day that most patients in the study experienced CANV and a lowered level of performance status and satisfaction with care. From day 2 to day 7, the descriptive data in Table 2 records that fewer patients in both of the intervention groups suffered from vomiting when compared with the control groups. These are evidence of how the theoretical framework of neural pathways was at work, transmitting emetic stimuli (Fessele, 1996) to patients in the intervention groups. The advantage of relaxation and education in reducing vomiting could be attributed to their functions in interfering with the stimulation transmission of the cerebral cortex pathway, the vestibular system, the chemoreceptor trigger zone, and the afferent vagal and visceral nerves (Wong et al., 2010). Despite there being no statistical difference in the intake of antiemetics between the intervention and the control groups, descriptive data suggest that more patients in the intervention groups used antiemetics at day 0 before the commencement of CT, whereas no patient in the control groups did this. A major part of the educational component was promoting the use of antiemetics as a preventive measure. This increase in antiemetic intake was viewed as an outcome measure of the intervention, as well as a mediating factor that produced an improvement in the management of nausea and vomiting. Given that the severity of CANV increases with time, the findings in this pilot study consolidate the importance of providing chemotherapy-naïve patients with preventive measures before CT starts. Common problems, such as anticipatory nausea and vomiting, experienced by 40% of patients (n ¼ 8) prior to CT in this study, may also be alleviated through the early intake of antiemetics.
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As for the management of CANV and the maintenance of body weight, no evidence was found to support the superiority of relaxation over patient education, or vice versa. Furthermore, there are variations of body weight from day to day resulting from many factors such as fluid status. The changes in body weight may not be clinically meaningful in nausea and vomiting research, whereas the possible effects in parental anxiety reduction were suggested because the parents' anxiety levels within both intervention groups reduced over time. Because previous studies have reported a significant correlation between CANV and parental anxiety, the intervention used in this pilot study has an important benefit towards the management of parental anxiety (Chan and Chang, 1999). The significant difference found between relaxation and education lies solely in their effects on calorie consumption. Opposite to the original idea that education sessions may help the patients to select an appropriate diet and promote calorie intake, it is surprising that calorie intake was significantly reduced in day 2 and 3 in the education group. Due to the small sample size, the result may be a reflection of a drastic reduction in caloric intake in a single child. Nevertheless, it seems that calorie intake is relatively stable in the relaxation group. The beneficial effect of relaxation on calorie intake found is consistent with the findings in a previous study (Burish and Tope, 1992). However, caloric intake is likely to fluctuate and to be influenced by many factors, such as adjustment to the hospital environment and the cancer diagnosis. Likewise, the daily body weight also greatly fluctuates because of intravenous hydration. This raises concerns about the problem of using daily body weight and caloric intake as outcome measures. The second objective of this pilot study was to make an assessment of the feasibility of the study design. The recruitment of the sample in this pilot study was feasible. However, it took 18 months (which was longer than expected) to recruit 20 eligible and consenting patients and parents when 65 eligible patients and parents were approached. The low response rate (30%) is expected in most pediatric studies. In many households in Hong Kong both parents are working, thus leaving them little time and energy to participate in research studies. Nevertheless, these ageappropriate interventions and the data collection process seemed appropriate, as all patients in the intervention groups adhered to the intervention and completed the instruments without difficulty. Data from process evaluation support the feasibility of both interventions. It appears that the patients' response to relaxation is better than those to education in aspects such as attention and the ability to follow instructions. The moderate to low levels of interest and participation in the education group are likely attributable to the sickness of the patients. Patients' and parents' perceived usefulness of intervention, especially the usefulness in anxiety reduction, also seem to be higher compared to that in the education group. Because relaxation works directly on the cerebral cortex pathway, which is associated with moods and emotions, the beneficial effect on anxiety reduction in the relaxation group is expected. Based on data from process evaluation, patients and parents appear to prefer relaxation to the education intervention. The third objective of the study was to make an assessment of the appropriateness of using the instruments MANE and STAI in children aged 4 to 11. All patients in this study gave a response in full to these Chinese instruments without any difficulty in understanding the statements reported. It is not feasible to establish the psychometric properties of these instruments due to the small sample size. Therefore, further testing in a larger study is warranted.
Limitations There are a few limitations in this pilot study. To begin with, the validity of findings was threatened by biased results which arose from the baseline difference in the child anxiety level between the two intervention groups. This covariate could not be controlled by the non-parametric tests used in this study. Because it is known that anxiety is associated with CANV, this difference would likely be prevented were a larger sample size or stratified random sampling to be used in future studies. Another limitation was the use of historical controls; this is because great variability may exist in the documentation. In addition, the low degree of emetogenicity of most treatments in induction has limited the chance of detecting a reduction in nausea and vomiting. In regard to process evaluation, patients' actual participation in the intervention process is revealed from the intervention log. However, there is a lack of information on the patients' and their parents' feelings towards the process and the outcome of the interventions. For example, the parents in the education group tended not to ask questions. It would be useful to know if they were not interested or if they were just overwhelmed by the diagnosis of cancer in their child. In future studies, qualitative interviews should be conducted to solicit this information and to supplement the outcome data. Lastly, it is not possible to delineate the effect of intervention which combines relaxation and education; this is because this study used two intervention groups to compare the effects of relaxation alone and education alone. Future study of a four-group factorial design to compare the effect of each single component and the combined intervention with a control group is recommended. Implications In cancer care, innovative and age-appropriate strategies to control CANV in pediatric cancer patients are important. However, their effectiveness has rarely been tested. The current pilot study has contributed promising preliminary findings which serve as good preparatory groundwork in supporting the development of innovative intervention to control CANV. Relaxation and patient education, which are the major components of a combined psychoeducational intervention, were ascertained and their potential effectiveness was explored. Taking into consideration the occurrence of anticipatory nausea and vomiting as well as the increase in severity of CANV over time, the most effective treatments are preventive measures provided before the commencement of CT. Both relaxation and education appear to have similar effects in reducing CANV, although the patients' and the parents' perceived usefulness of relaxation in terms of anxiety reduction is higher compared with that towards education. In future study, a multi-dimensional psychoeducational program combining the use of relaxation and education to block all pathways of emetic stimuli will be assessed by the research team. For that combined psychoeducational program in the management of CANV and anxiety, a stronger effect will be expected. Since nurses are playing a vital role in CANV prevention and management, they should be well-equipped to facilitate assessment, education and management of CANV (Krishnasamy et al., 2013; So et al., 2013). Conclusion From the experience of the current pilot study, the study design is feasible and appropriate in terms of the recruitment of
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participants, randomization, and the implementation of interventions and the measurement of outcomes. Both relaxation and education are well accepted by the patients and their parents. Also, better responses to the intervention process and higher levels of perceived usefulness of intervention were given by patients in the relaxation group compared to those in the education group. The sample was far too small to detect any difference in outcomes across the different study groups. Nevertheless, descriptive data suggest that there are beneficial effects of interventions in reducing vomiting, and promoting the intake of antiemetics as a preventive measure. Acknowledgments The project was funded by the Health and Health Service Research Fund in Hong Kong e Ref: 02030031. We are indebted to the patients, nursing and medical staff in the Department of Pediatrics at the Prince of Wales Hospital for their invaluable support and assistance in carrying out this study. Appendix. A Patients' and parents' education. Contents
Activities
Duration
Provision of age-specific information
1 Provide preparatory information on CANV 2 Screen risk factors such as motion sickness and emotional state 1 Explain the actions of antiemetics 2 Explore patient/parent perception of the use of antiemetics 3 Clarify misconceptions 4 Recommend creative ways in the administration of antiemetics such as the use of distraction 1Screen noxious stimuli and discuss ways to avoid them 2 Assess child's food preferences 3 Explain the importance of nutritional and hydration support 4Discuss principles of meal preparation during CANV 5 Emphasize individual differences in meal preparation and encourage parents to share their concerns
10 min
Promoting the use of antiemetics
Advice on meal preparation to enhance hydration and nutritional intake
Interventions and data collection periods are stipulated, as follows: Day Day Day Day Day Day Day Day Day Day 0 1 2 3 4 5 6 7 30 60 Group 1 intervention: relaxation (including PMR and GI) Group 2 intervention: education MANE Anxiety Satisfaction with care Caloric intake, body weight, antiemetics use Performance status Usefulness of intervention Intervention log Pulse and blood pressure (Group 1 only) Health diary of PMR and GI (daily for two months continuously) (Group 1 only) Control group historical data: body weight, vomiting, antiemetics use
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Day 0 ¼ one day prior to chemotherapy; day 1 ¼ chemotherapy commencement date.
Conflict of interest 10 min
None declared.
References 10 min
1 The patient education protocol was developed based on recommendations from Chan et al. (2011), Fessele (1996), and Keller (1995), and it has been rated as relevant and appropriate by an expert panel of academics and clinicians. 2 Patients and parents are allowed to have time to ask questions and they have the opportunity for obtaining repeated information in an unhurried manner.
Appendix. B
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Arakawa, S., 1997. Relaxation to reduce nausea, vomiting, and anxiety induced by chemotherapy in Japanese patients. Cancer Nursing 20 (5), 342e349. Burish, T.G., Tope, D.M., 1992. Psychological techniques for controlling the adverse side effects of cancer chemotherapy: findings from a decade of research. Journal of Pain and Symptom Management 7 (5), 287e301. Chan, C.W.H., Chang, A.M., 1999. Stress associated with tasks for family caregivers of patients with cancer in Hong Kong. Cancer Nursing 22 (4), 260e265. Chan, C.W.H., Chang, A.M., Molassiotis, A., Lee, I.Y.M., Lee, G.C.T., 2003. Oral complications in Chinese cancer patients undergoing chemotherapy. Supportive Care in Cancer 11, 48e55. Chan, C.W.H., 2005. Psychoeducational intervention: a critical review of systematic analyses. Clinical Effectiveness in Nursing 9 (3e4), 101e111. Chan, C.W.H., Thompson, D.R., 2006. The use of placebo in clinical nursing research. Journal of Clinical Nursing 15, 521e524. Chan, C.W.H., Cheng, K.K.F., Lam, L.W., Li, C.K., Chik, K.W., Cheung, J.S.S., 2007. Theory-driven intervention for reducing nausea and vomiting and promoting quality of life in pediatric cancer patients: a pilot study. Paper Presented at the Shanghai International Nursing Conference 125e126. Chan, C.W.H., Richardson, A., Richardson, J., 2011. Managing symptoms in patients with advanced lung cancer during radiotherapy: results of a psychoeducational randomized controlled trial. Journal of Pain and Symptom Management 41 (2), 347e357. Chan, C.W.H., Richardson, A., Richardson, J., 2012. Evaluating complex intervention: a process evaluation of a psychoeducational intervention in patients receiving palliative lung cancer radiotherapy. Contemporary Nurse 40 (2), 234e244. Fessele, K.S., 1996. Managing the multiple causes of nausea and vomiting in the patient with cancer. Oncology Nursing Forum 23 (9), 1409e1415. Hockenberry-Eaton, M., Benner, A., 1990. Patterns of nausea and vomiting in children: nursing assessment and intervention. Oncology Nursing Forum 17 (4), 575e584. Holdsworth, M.T., Raisch, D.W., Duncan, M.H., Chavez, C.M., Leasure, M.M., 1995. Assessment of chemotherapy-induced emesis and evaluation of a reduced-dose intravenous ondansetron regimen in pediatric outpatients with leukemia. The Annals of Pharmacotherapy 29 (1), 16e21. Ismail, Z., So, W.K.W., Li, P.W.C., 2010. Preoperative uncertainty and anxiety among Chinese patients with gynecologic cancer. Oncology Nursing Forum 37 (1), E67eE74. Joss, R.A., Brand, B.C., Buser, K.S., Cerny, T., 1990. The symptomatic control of cytostatic drug-induced emesis. A recent history and review. European Journal of Cancer 1 (26 Suppl. l), S2eS8.
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Keller, V.E., 1995. Management of nausea and vomiting in children. Journal of Pediatric Nursing 10 (5), 280e286. Krishnasamy, M., So, W.K.W., Yates, P., de Calvo, L.E.A., Annab, R., Wisniewski, T., et al., 2013. The nurse's role in managing chemotherapy-induced nausea and vomiting: an international survey. Cancer Nursing. http://dx.doi.org/10.1097/ NCC.0b013e3182a3534a. Ladas, E.J., Post-White, J., Hawks, R., Taromina, K., 2006. Evidence for symptom management in the child with cancer. Journal of Pediatric Hematology/ Oncology 28 (9), 601e615. Lansky, L.L., List, M.A., Lansky, S.B., Cohen, M.E., Sinks, L.B., 1985. Toward the development of a play performance scale for children (PPSC). Cancer 56, 1837e1840. Leung, S.S.F., 1996. Growth standard of southern chinese. Department of Pediatrics. The Chinese University of Hong Kong. Available from: http://www.cuhk.edu.hk/ proj/growthstd/english/gs_food.htm. Li, C.K., Chan, C.W.H., Goggins, W., Cheng, K.K.F., Chien, W.T., Yuen, H.L., et al., 2010. A survey on health status and health related quality of life of childhood cancer survivors in Hong Kong. Pediatric Blood & Cancer 55 (5), 840. Li, W.H.C., Lopez, V., 2004. Psychometric evaluation of the Chinese version of the state anxiety scale for children. Research in Nursing & Health 27 (3), 198e207. Li, H.C.W., Wong, M.L.E., Lopez, V., 2008. Factorial structure of the Chinese version of the state anxiety scale for children (short form). Journal of Clinical Nursing 17 (13), 1762e1770.
Molassiotis, A., Yung, H., Yam, B.M.C., Chan, F.Y.S., Mok, T.S.K., 2002. The effectiveness of progressive muscle relaxation training in managing chemotherapyinduced nausea and vomiting in Chinese breast cancer patients: a randomized controlled trial. Supportive Care in Cancer 10 (3), 237e246. Morrow, G.R., 1992. A patient report measure for the quantification of chemotherapy-induced nausea and emesis: psychometric properties of the Morrow assessment of Nausea and Emesis (MANE). British Journal of Cancer 19 (66 Suppl. l), S72eS74. Redd, W.H., Montgomery, G.H., DuHamel, K.N., 2001. Behavioral intervention for cancer treatment side effects. Journal of National Cancer Institute 93 (11), 810e823. Snyder, M., Lindquist, R., 2002. Complementary/Alternative Therapies in Nursing, fourth ed. Springer Publishing Company, New York. So, W.K.W., Chan, D.N.S., Chan, H.Y.L., Krishnasamy, M., Chan, T., Ling, W.M., et al., 2013. Knowledge and practice among Hong Kong oncology nurses in the management of chemotherapy-induced nausea and vomiting. European Journal of Oncology Nursing 17 (3), 370e374. Tsoi, M.M., Ho, E., Mak, K.C., 1986. Becoming pregnant again after still birth or the birth of a handicapped child. In: Dennerstein, L., Fraser, I. (Eds.), Hormones and Behavior. Elsevier Science, Amsterdam, pp. 310e316. Wong, E.M.L., Chan, S.W.C., Chair, S.Y., 2010. Effectiveness of an educational intervention on levels of pain, anxiety and self-efficacy for patients with musculoskeletal trauma. Journal of Advanced Nursing 66 (5), 1120e1131.
Contents lists available at ScienceDirect
European Journal of Oncology Nursing journal homepage: www.elsevier.com/locate/ejon
Feasibility of psychoeducational interventions in managing chemotherapy-associated nausea and vomiting (CANV) in pediatric oncology patients Carmen W.H. Chan a, *, Lai Wah Lam a, Chi Kong Li b, Jeanny S.S. Cheung b, Karis K.F. Cheng c, Ki Wai Chik b, Helen Y.L. Chan a, Winnie K.W. So a, Winnie P.Y. Tang a a b c
Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong Department of Paediatrics, Prince of Wales Hospital, Hong Kong National Singapore University, Hong Kong
a b s t r a c t Keywords: Oncology Pediatric Nausea Vomiting Chemotherapy Psychoeducation intervention
Purpose: Childhood cancer patients often suffer from Chemotheraphy-Associated Nausea and Vomiting (CANV). To alleviate CANV, relaxation techniques and patient education were combined to develop a multidimensional psychoeducational intervention package. The aim of this pilot study was to assess the feasibility of the two major components, namely, (1) relaxation, and (2) patient education, of a psychoeducational intervention, prior to the commencement of the main study. Methods: A pre-testepost-test control group design was adopted. Twenty patients were allocated equally to the relaxation group (10 participants) and to the educational group (10 participants). Twenty historical matched control cases were identified to form the control groups. Besides, a process evaluation was adopted to assess the feasibility of the study. Results: In relation to episodes of vomiting on day 3, a significant difference was detected from the results (X2 ¼ 8.54, p ¼ 0.036), in that fewer patients in the relaxation group experienced vomiting. A significant difference was not found in both the use of antiemetics and body weight between the groups. All subjects in the intervention groups adhered to the intervention and completed the questionnaire without difficulty. Patients and parents perceived the intervention as being moderately useful. Conclusions: Although the beneficial effect of relaxation and education in alleviating CANV was not wellsupported statistically, the findings from descriptive data suggest that these interventions promoted the intake of antiemetics as a preventive method. Both interventions and instruments were well-received by the patients and also by their parents. © 2014 Elsevier Ltd. All rights reserved.
Introduction In the treatment of childhood malignancies, intensive chemotherapy (CT) regimens are often used. In general, they are more emetogenic compared to those used in adults (Chan et al., 2007). CANV normally appears one to 2 h after CT has started and it then persists for six to 12 h or even for a few days post the CT cycle (Molassiotis et al., 2002; Chan et al., 2003). Limited studies were carried out on the management of CANV in children, and a majority of the existing literature places an emphasis on pharmacological intervention.
* Corresponding author. E-mail address: [email protected] (C.W.H. Chan). http://dx.doi.org/10.1016/j.ejon.2014.09.002 1462-3889/© 2014 Elsevier Ltd. All rights reserved.
The immediate adverse effects of CANV in young children include dehydration, electrolyte imbalance, and weight loss (Keller, 1995). Later problems can follow; these are, for example, an increased susceptibility to infections and a decreased renal elimination of drugs (Joss et al., 1990). Without the proper initial control of CANV, the development of conditioned nausea and vomiting, avoidance of care, patients' self-deprecation, and even a refusal of CT can be found in pediatric patients, together with parental anxiety (Chan et al., 2007). Because children with CANV often experience changing preferences towards food, the odors or colors that are particular to the ward can nauseate them (Hockenberry-Eaton and Benner, 1990). It has been reported that CANV is significantly correlated with motion sickness, the child's anxiety, and parental anxiety (Chan et al., 2007). This may seriously compromise the
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quality of life of pediatric patients suffering from CANV (Li et al., 2010). Theoretical framework Nausea and vomiting result from the stimulation of the vomiting center in the brain (Fessele, 1996). This can happen through the following four pathways: (a) the cerebral cortex and limbic system; (b) the vestibular system; (c) the chemoreceptor trigger zone; and (d) the afferent vagal and visceral nerves. Despite the growing availability of more potent antiemetics every year, the efficacy of these drugs is not guaranteed to all patients and no single drug can be effective against CANV which results through multiple pathways (Fessele, 1996; Holdsworth et al., 1995). A hypothesis is proposed that multi-dimensional intervention is more effective provided that more than one pathway is blocked (Fig. 1). Preventive measures for chemotherapy-naïve patients are regarded as the most effective treatment because the severity of CANV may increase with time (Chan et al., 2007). Founded on the theoretical framework of the neural pathways involved in transmitting emetic stimuli (Fessele, 1996), the authors have developed a multi-dimensional psychoeducational program which combines the use of relaxation techniques and patient education (Chan and Thompson, 2006; Chan et al., 2011; Fessele, 1996; Keller, 1995) (Fig. 1). Relaxation works by blocking the cerebral cortex pathway whereas patient education emphasizing risk assessment, the use of antiemetics, and meal preparation works by blocking the remaining three pathways. Although it sounds logical to block all the pathways of emetic stimuli by adopting a comprehensive program, every major component of the program has to be examined individually in an exploratory trial to ascertain its effect (Chan and Thompson, 2006). Most studies have reported that psychoeducational interventions are effective in treating CANV in adults (Arakawa, 1997; Molassiotis et al., 2002; Redd et al., 2001). Other effects reported are the reduction of negative emotions and physiological arousal, and an improvement in caloric intake and greater satisfaction with the care received (Burish and Tope, 1992). Among these psychoeducational interventions, relaxation techniques are the most widely researched; they include the combined use of progressive muscle
Reducing anxiety by PMR and GI
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relaxation (PMR) and guided imagery (GI) (Chan et al., 2011). As defined, PMR is the progressive tensing and relaxing of successive muscle groups, and GI is a technique which uses a favorable and relaxing mental image to distract an individual's attention from the distressful side of the CT administration (Snyder and Lindquist, 2002). It has been reported that nurses can successfully deliver PMR and GI to cancer patients and receive favorable responses (Chan et al., 2011, 2012; Molassiotis et al., 2002). Young children undergoing the pre-operational and concrete operational developmental stages (aged 4e11) are more responsive to distraction and imagination and they also have the faculty of logical thought. Therefore, the PMR and GI techniques which are taught to adults can also be adopted for children as young as preschoolers (Ladas et al., 2006; Redd et al., 2001). Although the adoption of psychoeducational interventions in handling pain and general distress is frequently suggested in pediatric oncology literature (Chan, 2005; Ladas et al., 2006), the effect of such interventions on CANV has rarely been examined in children. This pilot study serves as a pioneer which explores multiple components in a comprehensive program with the ultimate aim of blocking all four emetic pathways. Aims The aim of this pilot study was to assess the feasibility of the two major components, namely, (1) relaxation, and (2) patient education, of a psychoeducational intervention, prior to the commencement of the main study. The objectives of this pilot study were as follows: (1) to estimate the effect size of relaxation and patient education on the reduction and occurrence of CANV, improvement in the use of antiemetics, calorie intake, body weight, anxiety, satisfaction with care, and performance status; (2) to assess the feasibility of the study design, including recruitment, implementation of intervention, and measurement of outcomes, by process evaluation; and (3) to evaluate the suitability of using the instruments the Morrow Assessment of Nausea and Emesis (MANE) (Morrow, 1992) and the Chinese version of A-State scale of the StateTrait Anxiety Inventory (STAI) (Tsoi et al., 1986) in children
Cerebral cortex pathway (related to mood, feeling, and emotion)
Chemoreceptor trigger zone (related to chemical signals from the bloodstream)
Advice on and support for the use of antiemetics
Stimulation of vomiting center
Advice on risk factors, e.g., motion sickness
Vestibular system (related to motion sickness)
Afferent vagal and visceral nerves (related to gastrointestinal irritation or distension)
Advice on meal preparation
Remarks: PMR: progressive muscle relaxation; GI: guided imagery. Fig. 1. Theoretical rationale supporting the relationship between CANV and proposed intervention. PMR: progressive muscle relaxation; GI: guided imagery.
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(2) having advanced-stage cancer.
aged 4 to11 by assessing the level of completeness of these instruments.
Materials and methods Design This pilot study was an exploratory trial using a pre-testeposttest control group design. Process evaluation was also adopted to assess the feasibility, acceptance and appropriateness of the study. Setting and participants The research assistant (RA) recruited a total of 20 patients and their parents from the pediatric oncology unit of a publicly-funded hospital in Hong Kong. The most common age of the patients receiving treatment at the participating hospital was 5.4-years-old and there were about 25e30 eligible participants per year. The inclusion criteria of patient participants were as follows: (1) (2) (3) (4) (5)
aged 4e11; diagnosis of cancer and receiving CT; chemotherapy-naïve; able to understand Chinese; and signed informed consent (both by patients and parents).
The exclusion criteria were as follows: (1) having brain metastasis; and/or
We formed a total of two intervention groups and two control groups. Eligible and consenting patients were randomly recruited to form Group 1 (10 participants) (the relaxation group) and Group 2 (10 participants) (the education group) by the lucky draw method (Fig. 2). Historical data, including body weight, occurrence of vomiting, and intake of antiemetics, were collected from another 20 matched control participants identified from medical records. The control participants' age, disease, and the emetogenicity of chemotherapy agents were matched with intervention participants. Group 3 was formed by ten historical control cases who matched the characteristics of the Group 1 participants, whereas the other ten historical control cases matching the characteristics of the Group 2 participants formed Group 4. Interventions The authors have developed a psychoeducational program with reference to the recommendations from existing literature (Fessele, 1996; Keller, 1995; Li et al., 2008). An expert panel of academics and clinicians has rated the program as relevant and appropriate. It consists of two major components: relaxation, and patient's education. Patients in Group 1 received six sessions of daily PMR and GI training (day 0 to day 5) (30 min/session), as recommended by Chan et al. (2011) and Molassiotis et al. (2002), and daily selfpractice of the skill for a period of two months. Participants were provided with a PMR and GI audiotape.
Assessed for eligibility (n = 75)
Enrollment
Excluded (n = 10) Declined to participate (n = 45)
Randomized (n = 20)
Allocated to PMR group (n = 10) Received allocated intervention (n = 10 ) Did not receive allocated intervention (n = 0)
Allocation
Allocated to education group (n = 10) Received allocated intervention (n = 10) Did not receive allocated intervention (n = 0)
Lost to follow-up from day 0–day 60 (n = 0) Discontinued intervention (n = 0)
Follow-up
Lost to follow-up from day 0–day 60 (n = 0) Discontinued intervention (n = 0)
Analysis
Included in PMR group analysis (n = 10)
Included in PMR group analysis (n =10)
Fig. 2. Consolidated standards of reporting trails (CONSORT) flowchart.
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Patients in Group 2 received two sessions of patients/parents education (on day 0 and day 2) (30 min per session); this focused on risk assessment, antiemetics use and meal planning. Details are shown in Appendix A. Parents were invited to participate as co-learners and supporters in both of the intervention groups. They also encouraged and assisted the young children to respond to the questionnaire. An RA with two years of pediatric nursing experience delivered the intervention. The RA underwent a two-day training program; this focused on communication skill, latest cancer treatment and side-effects, and the practice of PMR and GI. The usual care of the participating patients (including the control subjects) in the ward involves antiemetic Ondansetron intravenously on a need base and the usual diet advice focusing on avoiding spicy and greasy food. Recommended food should be easily swallowed and digested. Participants in both of the intervention and control (historical data) groups received this usual care. Outcome measures Primary outcome measures: occurrence of nausea and vomiting. Secondary outcome measures: use of antiemetics, anxiety (child and parent), physiological indices (caloric intake, changes in body weight), performance status, satisfaction with care (child and parent). Process evaluation data Self-rating of the usefulness of intervention (child and parent), activity log, and daily PMR and GI practice. Instruments Instruments 1 to 8 were used to estimate the effect size of the tested interventions. Nausea and vomiting The MANE (Morrow, 1992) was used to measure the occurrence, intensity and the duration of CANV. A higher score indicates more severe CANV. The mean testeretest reliability coefficients of MANE ranged from 0.72 to 0.96 across different studies. A Chinese version of the scale was translated by Molassiotis et al. (2002) and it tested as valid and reliable. It has been further tested by the research team in 15 eligible child cancer patients (aged 6e18) with a testeretest reliability of 0.82e0.9. These children did not report any difficulty in answering the questions. Its appropriateness for children aged 4 to 11 was pilot-tested in this study. Anxiety The Chinese version of the A-State scale of the State-Trait Anxiety Inventory (STAI) (Tsoi et al., 1986) was used to assess the state of anxiety of the parents. The A-State scale consists of 20 items for measuring the immediate feelings of apprehension, nervousness and worry. A higher score indicates more severe anxiety. An internal consistency of 0.92 has been reported in the Chinese version of A-State scale (Ismail et al., 2010). The Chinese version of the Children STAI A-State scale was selected to assess the anxiety of pediatric patients (Li and Lopez, 2004; Li et al., 2008). The testeretest reliability coefficients for the Chinese children A-State scale were 0.80 and 0.78, and internal consistencies ranged from 0.84 to 0.94 in studies of patients with different age groups. Criterion-related validity was confirmed by
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positive correlation of the Chinese A-State scale with children's heart rate (r ¼ 0.49) and mean blood pressure (r ¼ 0.40). The construct validity of the scale was confirmed by administering the scale to 237 primary school students (aged 6e12) in Hong Kong. Usage of antiemetics This was obtained from the medical record of the actual use of the antiemetics. History of motion sickness This history was obtained from interviewing parents and patients, and it was then verified by reference to medical records. Physiological indices Pulse rate and blood pressure (for Group 1 only) was recorded 15 min before and after each PMR and GI session to assess the immediate physiological relaxation effects. Caloric intake was collected by asking parents and patients (of both Groups 1 and 2) to maintain an accurate food diary of the patients' intake of all foods and fluids. The RA calculated the caloric value of each food item in accordance with the Growth Standard of Southern Chinese published by the Department of Pediatrics, The Chinese University of Hong Kong (Leung, 1996). Daily body weight Body weight was measured daily before breakfast at 7 or 8 a.m. For the patients who had been discharged home, their parents followed our instructions to collect daily body weight before breakfast. Satisfaction with care Patients' and parents' satisfaction with their care during the intervention period was examined by a self-reported 4-point likert scale; this indicates “extremely unsatisfactory” (0) to “extremely satisfactory” (3). Self-reporting likert scales are commonly used as a tool to assess satisfaction levels. Performance status Patients' performance status was assessed by the Play Performance Scale for Children (Lansky et al., 1985). The scale is a simple score of 0e100, checked by the RA. A higher score indicates better performance. The scale has been validated in the participating hospital with pediatric oncology patients aged 1 to 16. The major roles of children focus on play, and therefore play is adopted as the yardstick of performance. Changes in a child's performance are generally accepted as an aid to evaluate the efficacy of treatment and a child's quality of life (Lansky et al., 1985). Items 9, 10, and 11 hereunder were used to measure the process outcomes. Intervention activity log The authors have set up an intervention activity log to evaluate the process of intervention delivery. In each session, the RA used the activity log to record problems encountered during the implementation of the interventions. The comments and concerns raised by the participants about the interventions were recorded. The RA also checked the patients' actual time spent on the
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intervention and the participation levels, such as their attention span and their ability to demonstrate the PMR and GI. Self-rating of the usefulness of intervention The patients' and parents' self-rating of the usefulness of each intervention component was assessed by a 6-point likert scale; this indicates “extremely useful” (5) to “not at all useful” (0). Practice of PMR and GI Parents and patients in intervention Group 1 were required to keep a simple health diary to record the patient's self-practice of PMR and GI for a period of two months. Procedures Appendix B shows a flow chart of the procedure and data collection period. All consenting participants completed a whole set of instruments at baseline and at seven days after CT was implemented, with eight days' measurements in total. This data collection schedule was recommended in previous studies to assess the acute and delayed CANV (Arakawa, 1997; Molassiotis et al., 2002). Longterm data collected at the end of one month and two months, respectively, were performance status, anxiety, compliance with PMR and GI (Group 1 only), and satisfaction with care. Generally, two cycles of CT were covered in this two-month data collection period. Data collection and interventions were carried out either at the patient's home or on the ward (where more feasible); this was because most of the patients were discharged home at day 2 to day 3 after CT was completed. In 20 matched control participants, historical data, including body weight, occurrence of vomiting, and intake of antiemetics, were collected from the medical records. The control participants' age, disease and emetogenicity of the chemotherapy agents were matched with intervention participants by the RA. All these data were objective in nature and easily traced from the patients' medical records. Data analysis Chi-square, ManneWhitney U tests and Kruskal Wallis tests were used to compare the characteristics and outcomes of participants between the intervention and the control groups. Withingroup comparisons were done by the use of Friedman tests. Results We approached 65 patients who met the eligibility criteria and 20 of them consented to participate in the study, yielding a response rate of 30.7%. Despite the low response rate, none of the recruited patients withdrew throughout the 60 days of the data collection period. Baseline characteristics of the study sample The age of study participants ranged from 4 to 11 years old, with the mean age of 8.6 years old. The majority of them (n ¼ 20) suffered from lymphocytic leukaemia, followed by osteosarcoma (n ¼ 12). No participant had experienced vomiting immediately after CT at baseline (day1). To analyze the baseline characteristics of participants between the intervention and control groups at day 0, Chi-square and Kruskal Wallis tests were used. No difference was found in their diagnoses, age, and body weight at baseline.
To compare the baseline outcome measures between the two intervention groups, Chi-square and ManneWhitney U tests were used. The results showed that patients in Group 1 had significantly lower levels of child anxiety (Z ¼ 2.14, p ¼ 0.032) at baseline. Parents of patients in Group 1 also had a lower mean score of anxiety, but it is not statistically significant. Regarding other demographic and clinical variables, no difference was found. Outcome evaluation from day 0 to day 7 Comparison between intervention groups and control groups The body weight, occurrence of vomiting, and the use of antiemetics between the intervention and control groups was compared by Kruskal Wallis tests and Chi-square tests. Withingroup changes were tested by Friedman tests. Because the historical control groups did not have data on the severity and duration of vomiting, only the occurrence was reported here for comparison. Table 1 shows the comparison of body weight from day 0 to day 7. No significant difference (p > 0.05) was detected between the groups at each data collection time. All groups experienced a slight decrease in body weight (less than 1 kg) over the eight-day period. Significant within-group changes in body weight were found in Group 2 only (p ¼ 0.01). Due to the small sample size, the research team was unable to compare changes over time between the groups. A significant difference in the occurrence of vomiting after the commencement of CT was detected only on day 3 (Pearson Chi Square ¼ 8.54, p ¼ 0.036), thereby indicating that fewer patients in the relaxation group (Group 1) experienced vomiting (Table 2). Descriptive data show that on day 0, none of the patients in the control groups took antiemetics. On day 2, more patients in the control groups than those in the intervention groups took antiemetics. On the other hand, more patients in the intervention groups took antiemetics on day 0 and day 1, and subsequently fewer patients in these groups took antiemetics from day 2 onwards. Comparison between the relaxation group and the education group There were no statistical differences in body weight, the occurrence of nausea and vomiting, the intake of antiemetics, and anxiety level (p > 0.05) between the two intervention groups (Tables 1e3). Both Groups 1 and 2 had significant within-group changes in parent anxiety levels (Group 1 at p ¼ 0.005, Group 2 at p ¼ 0.001), in that the parents' levels of anxiety decreased over time from day 0 to day 60. However, the with-group changes in the children's anxiety level were not significant in both Groups 1 and 2 (Table 3). There was no significant difference in the children's performance status and the parents' satisfaction with care between the Table 1 Body weight of each study group from day 0eday 7 (in kg). Group Gp 1 Gp 2* Gp 3 Gp 4 Total
Mean SD Mean SD Mean SD Mean SD Mean SD
Day 0
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
37.93 16.52 41.29 14.63 40.83 19.16 45.19 17.37 41.31 16.54
38.29 16.96 41.65 14.80 40.99 19.57 44.88 17.64 41.45 16.81
38.08 16.97 41.51 14.96 40.87 19.39 44.85 17.52 41.32 16.78
37.69 16.57 41.18 14.59 40.49 19.28 44.66 17.57 41.00 16.61
37.54 16.38 40.82 14.40 40.31 19.22 44.56 17.60 40.80 16.52
37.80 16.30 41.02 14.30 40.14 19.26 44.49 17.71 40.86 16.50
37.49 15.97 40.95 14.40 40.24 19.33 44.30 17.65 40.74 16.46
37.43 15.76 40.93 14.19 40.20 19.10 44.28 17.44 40.71 16.26
*significance level at p < 0.05. Gp 1: relaxation group. Gp 2: education group. Gp 3: historical controls that matched the characteristics of Group 1. Gp 4: historical controls that matched the characteristics of Group 2.
C.W.H. Chan et al. / European Journal of Oncology Nursing 19 (2015) 182e190 Table 2 Number of patients in each group who had experienced nausea, vomiting and the intake of antiemetics from day 0eday 7.
Intake of antiemetics
Nausea before CT Vomiting before CT *Vomiting after CT
Nausea after CT
Group
Day 0
Day 1
Day 2
*Day 3
Day 4
Day 5
Day 6
Day 7
Gp Gp Gp Gp Gp Gp Gp Gp Gp Gp Gp Gp Gp Gp
5 7 0 0 1 1 5 3 0 0 0 0 0 0
5 6 3 4 1 3 0 0 0 0 1 0 2 5
4 3 8 10 2 4 1 3 2 3 3 7 5 6
2 5 3 3 3 6 2 5 4 7 6 10 4 8
1 4 2 3 2 6 1 3 3 7 7 6 4 8
1 4 1 3 2 4 1 1 2 1 5 6 4 8
0 0 1 1 3 2 1 1 2 2 6 5 5 4
1 0 0 0 3 2 2 1 4 1 5 5 6 6
1 2 3 4 1 2 1 2 1 2 3 4 1 2
*significance level at p < 0.05. Gp 1: relaxation group. Gp 2: education group. Gp 3: historical controls that matched the characteristics of Group 1. Gp 4: historical controls that matched the characteristics of Group 2.
relaxation group (Group 1) and the education group (Group 2). There was a trend that the children's performance status was lower at day 3 to day 30 than the rest of data collection period in both groups. There was no significant difference in calorie intake between the relaxation group and the education group. There was a trend that patients in both groups had their lowest calorie intake at day 2 to day 3. Their calorie intake gradually improved from day 4 to day 7 (Table 4). A Friedman test showed that the within-group changes of calorie intake in Group 2 were significant (p ¼ 0.001), with a drastic reduction in day 2 to day 3. Process evaluation As revealed by data collected from the intervention log, the patients in the relaxation group demonstrated a high attention to coaching, and a high ability to follow instructions and to perform returned demonstration with most of them staying full-time in the sessions. Meanwhile, the education group also demonstrated a high attention during the education session. Nevertheless, their level of
Table 3 Level of parent anxiety and child anxiety between the relaxation group (Group 1) and education group (Group 2) from day 0eday 60. Group
Parent anxiety (20e80)
Day 0
Day 3
Day 7
Day 30
Day 60
Gp 1**
Mean Std deviation Mean Std deviation Mean Std deviation
55.00 9.447 62.33 10.642 58.67 10.466
53.20 10.497 62.00 9.684 57.60 10.816
46.10 13.059 49.50 8.343 47.80 10.807
54.10 8.582 54.00 6.342 54.05 7.345
47.10 6.590 46.30 9.381 46.70 7.901
Gp 2*** Total Group
Child anxiety (20e80)
Day 0*
Day 3
Day 7
Day 30
Day 60
Gp 1
Mean Std deviation Mean Std deviation Mean Std deviation
41.60 7.043 49.00 6.481 45.30 7.603
45.40 8.249 48.20 7.131 46.80 7.641
47.00 7.180 47.60 5.985 47.30 6.441
44.20 7.084 46.20 7.146 45.20 7.001
43.10 6.557 46.30 7.959 44.70 7.284
Gp 2 Total
*significance level at p < 0.05. **significance level at p < 0.01. *** significance level at p < 0.001.
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Table 4 Calorie intake of the relaxation group and education group from day 0eday 7. Group Gp 1 (n ¼ 10) Gp 2* (n ¼ 10) Total (n ¼ 20)
Day 0 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Mean 1894 SD 795 Mean 2155 SD 760 Mean 2024 769
1328 678 1476 775 1402 713
1213 1203 801 515 1007 925
1147 737 804 658 976 703
1473 1177 1333 1133 1403 1126
1642 987 1479 859 1560 905
1682 1200 1748 950 1715 1054
1495 649 1632 464 1567 547
*significance level at p < 0.05.
interest and participation during discussions were moderate and they tended not to ask for further information. According to the results from the health diaries, a majority of the patients practiced PMR three or four times per week at home. This indicated a moderate compliance towards PMR self-practice. Regarding blood pressure or pulse after the practice of PMR, ManneWhitney tests did not detect a significant change. Patients' and parents' perceived usefulness of the interventions were moderately useful. A ManneWhitney U test detected a significant difference only in the day 1 anxiety reduction of parents (Z ¼ 0.314, P ¼ 0.032), thereby indicating that they perceived PMR to be a more useful practice in anxiety reduction. A trend was observed that the overall “usefulness of intervention” scores in the relaxation group were higher in comparison with those in the education group. Discussion The first objective was to make an estimate of the effect size of relaxation and patient education, as used in managing CANV among pediatric cancer patients. Due to the small sample size and the use of non-parametric tests, the findings were not confirmatory in most comparisons, and therefore they could not fulfill the objective. However, a significant reduction in vomiting as a possible result of the effect of relaxation was reported at day 3, the day that most patients in the study experienced CANV and a lowered level of performance status and satisfaction with care. From day 2 to day 7, the descriptive data in Table 2 records that fewer patients in both of the intervention groups suffered from vomiting when compared with the control groups. These are evidence of how the theoretical framework of neural pathways was at work, transmitting emetic stimuli (Fessele, 1996) to patients in the intervention groups. The advantage of relaxation and education in reducing vomiting could be attributed to their functions in interfering with the stimulation transmission of the cerebral cortex pathway, the vestibular system, the chemoreceptor trigger zone, and the afferent vagal and visceral nerves (Wong et al., 2010). Despite there being no statistical difference in the intake of antiemetics between the intervention and the control groups, descriptive data suggest that more patients in the intervention groups used antiemetics at day 0 before the commencement of CT, whereas no patient in the control groups did this. A major part of the educational component was promoting the use of antiemetics as a preventive measure. This increase in antiemetic intake was viewed as an outcome measure of the intervention, as well as a mediating factor that produced an improvement in the management of nausea and vomiting. Given that the severity of CANV increases with time, the findings in this pilot study consolidate the importance of providing chemotherapy-naïve patients with preventive measures before CT starts. Common problems, such as anticipatory nausea and vomiting, experienced by 40% of patients (n ¼ 8) prior to CT in this study, may also be alleviated through the early intake of antiemetics.
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As for the management of CANV and the maintenance of body weight, no evidence was found to support the superiority of relaxation over patient education, or vice versa. Furthermore, there are variations of body weight from day to day resulting from many factors such as fluid status. The changes in body weight may not be clinically meaningful in nausea and vomiting research, whereas the possible effects in parental anxiety reduction were suggested because the parents' anxiety levels within both intervention groups reduced over time. Because previous studies have reported a significant correlation between CANV and parental anxiety, the intervention used in this pilot study has an important benefit towards the management of parental anxiety (Chan and Chang, 1999). The significant difference found between relaxation and education lies solely in their effects on calorie consumption. Opposite to the original idea that education sessions may help the patients to select an appropriate diet and promote calorie intake, it is surprising that calorie intake was significantly reduced in day 2 and 3 in the education group. Due to the small sample size, the result may be a reflection of a drastic reduction in caloric intake in a single child. Nevertheless, it seems that calorie intake is relatively stable in the relaxation group. The beneficial effect of relaxation on calorie intake found is consistent with the findings in a previous study (Burish and Tope, 1992). However, caloric intake is likely to fluctuate and to be influenced by many factors, such as adjustment to the hospital environment and the cancer diagnosis. Likewise, the daily body weight also greatly fluctuates because of intravenous hydration. This raises concerns about the problem of using daily body weight and caloric intake as outcome measures. The second objective of this pilot study was to make an assessment of the feasibility of the study design. The recruitment of the sample in this pilot study was feasible. However, it took 18 months (which was longer than expected) to recruit 20 eligible and consenting patients and parents when 65 eligible patients and parents were approached. The low response rate (30%) is expected in most pediatric studies. In many households in Hong Kong both parents are working, thus leaving them little time and energy to participate in research studies. Nevertheless, these ageappropriate interventions and the data collection process seemed appropriate, as all patients in the intervention groups adhered to the intervention and completed the instruments without difficulty. Data from process evaluation support the feasibility of both interventions. It appears that the patients' response to relaxation is better than those to education in aspects such as attention and the ability to follow instructions. The moderate to low levels of interest and participation in the education group are likely attributable to the sickness of the patients. Patients' and parents' perceived usefulness of intervention, especially the usefulness in anxiety reduction, also seem to be higher compared to that in the education group. Because relaxation works directly on the cerebral cortex pathway, which is associated with moods and emotions, the beneficial effect on anxiety reduction in the relaxation group is expected. Based on data from process evaluation, patients and parents appear to prefer relaxation to the education intervention. The third objective of the study was to make an assessment of the appropriateness of using the instruments MANE and STAI in children aged 4 to 11. All patients in this study gave a response in full to these Chinese instruments without any difficulty in understanding the statements reported. It is not feasible to establish the psychometric properties of these instruments due to the small sample size. Therefore, further testing in a larger study is warranted.
Limitations There are a few limitations in this pilot study. To begin with, the validity of findings was threatened by biased results which arose from the baseline difference in the child anxiety level between the two intervention groups. This covariate could not be controlled by the non-parametric tests used in this study. Because it is known that anxiety is associated with CANV, this difference would likely be prevented were a larger sample size or stratified random sampling to be used in future studies. Another limitation was the use of historical controls; this is because great variability may exist in the documentation. In addition, the low degree of emetogenicity of most treatments in induction has limited the chance of detecting a reduction in nausea and vomiting. In regard to process evaluation, patients' actual participation in the intervention process is revealed from the intervention log. However, there is a lack of information on the patients' and their parents' feelings towards the process and the outcome of the interventions. For example, the parents in the education group tended not to ask questions. It would be useful to know if they were not interested or if they were just overwhelmed by the diagnosis of cancer in their child. In future studies, qualitative interviews should be conducted to solicit this information and to supplement the outcome data. Lastly, it is not possible to delineate the effect of intervention which combines relaxation and education; this is because this study used two intervention groups to compare the effects of relaxation alone and education alone. Future study of a four-group factorial design to compare the effect of each single component and the combined intervention with a control group is recommended. Implications In cancer care, innovative and age-appropriate strategies to control CANV in pediatric cancer patients are important. However, their effectiveness has rarely been tested. The current pilot study has contributed promising preliminary findings which serve as good preparatory groundwork in supporting the development of innovative intervention to control CANV. Relaxation and patient education, which are the major components of a combined psychoeducational intervention, were ascertained and their potential effectiveness was explored. Taking into consideration the occurrence of anticipatory nausea and vomiting as well as the increase in severity of CANV over time, the most effective treatments are preventive measures provided before the commencement of CT. Both relaxation and education appear to have similar effects in reducing CANV, although the patients' and the parents' perceived usefulness of relaxation in terms of anxiety reduction is higher compared with that towards education. In future study, a multi-dimensional psychoeducational program combining the use of relaxation and education to block all pathways of emetic stimuli will be assessed by the research team. For that combined psychoeducational program in the management of CANV and anxiety, a stronger effect will be expected. Since nurses are playing a vital role in CANV prevention and management, they should be well-equipped to facilitate assessment, education and management of CANV (Krishnasamy et al., 2013; So et al., 2013). Conclusion From the experience of the current pilot study, the study design is feasible and appropriate in terms of the recruitment of
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participants, randomization, and the implementation of interventions and the measurement of outcomes. Both relaxation and education are well accepted by the patients and their parents. Also, better responses to the intervention process and higher levels of perceived usefulness of intervention were given by patients in the relaxation group compared to those in the education group. The sample was far too small to detect any difference in outcomes across the different study groups. Nevertheless, descriptive data suggest that there are beneficial effects of interventions in reducing vomiting, and promoting the intake of antiemetics as a preventive measure. Acknowledgments The project was funded by the Health and Health Service Research Fund in Hong Kong e Ref: 02030031. We are indebted to the patients, nursing and medical staff in the Department of Pediatrics at the Prince of Wales Hospital for their invaluable support and assistance in carrying out this study. Appendix. A Patients' and parents' education. Contents
Activities
Duration
Provision of age-specific information
1 Provide preparatory information on CANV 2 Screen risk factors such as motion sickness and emotional state 1 Explain the actions of antiemetics 2 Explore patient/parent perception of the use of antiemetics 3 Clarify misconceptions 4 Recommend creative ways in the administration of antiemetics such as the use of distraction 1Screen noxious stimuli and discuss ways to avoid them 2 Assess child's food preferences 3 Explain the importance of nutritional and hydration support 4Discuss principles of meal preparation during CANV 5 Emphasize individual differences in meal preparation and encourage parents to share their concerns
10 min
Promoting the use of antiemetics
Advice on meal preparation to enhance hydration and nutritional intake
Interventions and data collection periods are stipulated, as follows: Day Day Day Day Day Day Day Day Day Day 0 1 2 3 4 5 6 7 30 60 Group 1 intervention: relaxation (including PMR and GI) Group 2 intervention: education MANE Anxiety Satisfaction with care Caloric intake, body weight, antiemetics use Performance status Usefulness of intervention Intervention log Pulse and blood pressure (Group 1 only) Health diary of PMR and GI (daily for two months continuously) (Group 1 only) Control group historical data: body weight, vomiting, antiemetics use
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Day 0 ¼ one day prior to chemotherapy; day 1 ¼ chemotherapy commencement date.
Conflict of interest 10 min
None declared.
References 10 min
1 The patient education protocol was developed based on recommendations from Chan et al. (2011), Fessele (1996), and Keller (1995), and it has been rated as relevant and appropriate by an expert panel of academics and clinicians. 2 Patients and parents are allowed to have time to ask questions and they have the opportunity for obtaining repeated information in an unhurried manner.
Appendix. B
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