A feasibility study of a psychoeducational intervention program for gynecological cancer patients.

European Journal of Oncology Nursing xxx (2014) 1e8

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European Journal of Oncology Nursing journal homepage: www.elsevier.com/locate/ejon

A feasibility study of a psychoeducational intervention program for gynecological cancer patients Ka Ming Chow a, *, Carmen W.H. Chan a, Joanne C.Y. Chan a, Kai K.C. Choi a, K.Y. Siu b a b

The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong Special Administrative Region Department of Obstetrics & Gynecology, Prince of Wales Hospital, The Hospital Authority, Hong Kong Special Administrative Region

a b s t r a c t Keywords: Psychoeducational intervention Gynecological cancer Randomized controlled trial Feasibility study Hong Kong Chinese

Purpose of the research: This study aimed to test the feasibility of implementing a psychoeducational intervention program for gynecological cancer patients. Methods and sample: A single-blinded randomized controlled trial and mixed-method design were used. Study subjects were newly diagnosed gynecological cancer patients with surgery as the first-line treatment. They were randomly assigned to the intervention group, in which a psychoeducational intervention program based on a thematic counseling model was offered, or to the attention control group. Quantitative data on sexual functioning, quality of life, uncertainty, anxiety, depression and social support were collected at recruitment, post-operative and during the in-hospital period, and eight weeks after the operation. Participants in the intervention group and three nurses working in the clinical setting were invited to have semi-structured interviews. Key results: Of the 30 eligible subjects, 26 were successfully recruited into the study. Following the psychoeducational intervention program, there was significant improvement in the level of inconsistent information about the illness within the category of uncertainty among participants in the intervention group. In addition, trends towards improvement were demonstrated in quality of life, uncertainty, depression and perceived social support with the provision of the interventions. Qualitative data indicated the interventions were desired and appreciated by the participants, as well as being feasible and practical to implement in Hong Kong clinical settings. Conclusions: The findings suggest that it is feasible to deliver the psychoeducational intervention program and it may have beneficial effects in gynecological cancer patients. A full-scale study is warranted to confirm the results. Ó 2014 Elsevier Ltd. All rights reserved.

Introduction The diagnosis and treatment of gynecological cancer have detrimental effects on sexual functioning, quality of life and psychological outcomes of the patients. According to the National Cancer Institute (2012), 50% of gynecological cancer survivors suffered from long-term sexual dysfunction. Sexual morbidity was found to be associated with greater depression and stress symptoms among the patients (Levin et al., 2010). Both of these outcomes had negative impact on patients’ quality of life (Vaz et al., 2011).

* Corresponding author. 7/F, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong Special Administrative Region. Tel.: þ852 39434431; fax: þ852 26035269. E-mail address: [email protected] (K.M. Chow).

It is recommended that psychoeducational interventions should be incorporated into routine practice for gynecological cancer care to improve patient outcomes (Hordern and Currow, 2003; Levin and Silver, 2007). Caldwell et al. (2003) delivered a 12-week group psychoeducational intervention to post-operative gynecological cancer patients and found that their sexual functioning and mood disturbance improved. Brotto et al. (2008) also developed a brief, three-session psychoeducational intervention for women suffering from gynecological cancer and indicated that there was significant improvement in sexual functioning, distress, mood, quality of life and depression level. Nelson et al. (2008) delivered a six-session psychoeducational intervention program to cervical cancer survivors and found that the interventions enhanced their quality of life significantly, resulting in better clinical outcomes including survival. A systematic review of the effectiveness of psychoeducational interventions on gynecological cancer patients further confirmed

http://dx.doi.org/10.1016/j.ejon.2014.03.011 1462-3889/Ó 2014 Elsevier Ltd. All rights reserved.

Please cite this article in press as: Chow, K.M., et al., A feasibility study of a psychoeducational intervention program for gynecological cancer patients, European Journal of Oncology Nursing (2014), http://dx.doi.org/10.1016/j.ejon.2014.03.011

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K.M. Chow et al. / European Journal of Oncology Nursing xxx (2014) 1e8

that the interventions might improve depressive symptoms among gynecological cancer patients. In addition, the interventions appeared to improve patients’ sexual functioning, as well as reducing anxiety and distress to a certain extent (Chow et al., 2012). Furthermore, the review suggested the effective design of the interventions: theory-based, incorporating three components consisting of information provision, behavior therapy and psychological support, in which information concerning knowledge of the illness, treatment and self-care were given to the participants; behavior therapy, such as relaxation breathing exercises and coping skills, was carried out; psychological support was offered during the intervention process through counseling. Nurse was regarded as the most effective intervention provider, and a total of four sessions each lasting between 30 minutes and one hour, with the sessions starting before the beginning of the cancer treatment and continuing after discharge should be provided (Chow et al., 2012). The content covered in the psychoeducational interventions was driven by the thematic counseling model (Cain et al., 1986). The model was developed based on the findings of a long-term structured support group for gynecological cancer patients. This model was adopted in a previous study to design a psychosocial intervention for patients with soft tissue sarcoma to address their informational needs and psychological distress (Payne et al., 1997). A co-therapist format involving a clinical psychologist, research associate and surgeon was utilized as the intervention providers. The results showed that the participants had significantly reduced levels of feelings of isolation, anger, depression and anxiety. Moreover, they showed significant improvement in self-confidence. It was suggested that the intervention might enhance the quality of life of the patients (Payne et al., 1997). In Hong Kong, current clinical practice offers no psychoeducational interventions for gynecological cancer patients after discharge from hospital. Most information related to the disease and treatment, as well as post-operative care is provided as requested and on an ad-hoc basis. Care and interventions in sexual area have been especially neglected (Katz, 2005). The reasons for not discussing sexual issues include lack of time, lack of privacy, lack of education, and the belief that it was unnecessary to handle (Hautamäki et al., 2007). From the perspective of gynecological cancer patients, they wished to get sufficient information about the disease and its effects on sexual life (Rasmusson and Thomé, 2008). Marital satisfaction was found to be significantly correlated with sexual satisfaction in Chinese families (Guo and Huang, 2005). With this observation in mind, a psychoeducational intervention program is needed to address patients’ needs in Hong Kong. In the current study, the psychoeducational intervention program was designed for gynecological cancer patients according to the findings of the systematic review and thematic counseling model. The program is congruent with the Chinese culture that patients prefer to receive practical information first, followed by psychological care (Chan et al., 2011, 2012; Li et al., 2002). However, Chinese women are known to be reticent when discussing sexual topics with others: including health care professionals and partners (Gu et al., 2010, 2012). Therefore, the pilot study aimed at testing the feasibility and acceptability of the interventions to the patients in the Hong Kong Chinese context. On the other hand, cultural differences between other countries and Hong Kong may influence the effectiveness of the interventions. The effectiveness of the program on patient outcomes was also estimated in this study. As a result, the objectives of this feasibility study were to design a psychoeducational intervention program for gynecological cancer patients and test the feasibility of implementing the program in Hong Kong. The effectiveness of the program on sexual functioning, quality of life, uncertainty,

anxiety, depression and social support of the patients was also estimated. Methods The study was a single-blinded randomized controlled trial with a mixed-method design. Blinding was only performed on randomization. All the interventions and outcome measures were conducted by the researcher. As the psychoeducational intervention program was a series of complex interventions consisting of multiple components, evaluation of it required the use of quantitative and qualitative evidence (Campbell et al., 2000). A mixed method design allowed the collection of both types of data in the study process, and parallel data analysis permitted comparison of both data during the interpretative stage to understand whether the psychoeducational intervention program was feasible and acceptable to the target population. Quantitative and qualitative data can be used to supplement each other to provide comprehensive comments on the interventions (Östlund et al., 2011). The study setting was the obstetrics and gynecological department of a teaching hospital in Hong Kong. The study was undertaken between September 2012 and February 2013. Approval for the study was obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC). This randomized controlled trial has been registered in the Chinese Clinical Trial Registry (ChiCTR) with the registration number ChiCTR-TRC-12002663. Inclusion criteria for recruitment included women who had been newly diagnosed with gynecological cancer, scheduled to have surgery as the first-line treatment for the disease, over 18 years old, able to understand spoken Cantonese, a Chinese dialect, and to read Chinese wordings. The researcher approached eligible subjects in the out-patient clinic of the department and explained the study aims. An information sheet about the study was given to the participants and written informed consent was signed by them. Those consented to participate in the study were randomized into either an intervention group or an attention control group by a computer generated random codes in serially numbered opaque sealed envelopes. The randomization was performed by an independent statistician. Interventions Participants in the intervention group received a psychoeducational intervention program which was designed according to recommendations derived from the systematic review which has been illustrated before (Chow et al., 2012). A total of four sessions were provided in the program. The first session was delivered on recruitment in the out-patient clinic where surgeons met gynecological cancer patients to discuss their treatment plan. The other three sessions were implemented post-operatively and during the rehabilitative period. An individual format was used in the first three sessions, and a group format was adopted in the last session in order to conduct group counseling so as to provide opportunity for the participants to talk about their feelings and gain support from other people in similar situations. All the sessions were conducted by the researcher who was a registered nurse with eight years of clinical experience in gynecological oncology and three years of teaching experience. The schedule and details of the intervention program are listed in Table 1. In the attention control group, participants received attention from the researcher on four occasions over the same period as the intervention group. They met the researcher on recruitment, after the operation and during the in-hospital period. They were contacted four weeks after the operation via telephone, and invited to



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Table 1 Schedule and details of the psychoeducational intervention program. Session

Content

Activity

Components

1st session (before the start of cancer treatment) Individual format (45e60 min)

1. What is gynecological cancer? 2. Causes of gynecological cancer

- Provide accurate knowledge about cancer - Encourage expression of ideas about causes, and view that cancer is a disease with possibly multiple causes, but many are unknown - Provide accurate knowledge about common treatment for gynecological cancer: operation, chemotherapy, radiotherapy - Provide accurate knowledge about side effects of the related treatment - Management for these common side effects - Discuss the impact of related treatment on body image, sexuality and fertility - Clarify beliefs and values in sexuality - Correct any misunderstandings about sexual functioning - Encourage free discussion of fears and anxieties - Encourage expression of feelings and thoughts - Provide emotional support - Teach post-operative wound management and dietary advice - Demonstrate and return demonstrate deep breathing exercises - Discuss problem- and emotionfocused coping skills - Ask about general conditions after discharge - Counsel for problems encountered after operation and discharge - Encourage feelings expression, problems encountered and solutions - Positive group support - Impact of treatment on sexual functioning - Practical solutions to solve sexual problems - Encourage feelings expression on sexual life - Discuss communication skills - Encourage acceptance of feelings - Provide information of self-help groups and support groups in Hong Kong - Discuss issues of financial impact, returning to work

Information provision and psychological support

3. Treatment for gynecological cancer

4. Common side effects of related treatment

5. Impact of treatment on body image and sexuality

6 Psychological feelings after diagnosis of gynecological cancer 2nd session (after the operation and during the in-hospital period) Individual format (30e45 min)

1. 2. 3. 4.

Post-operative wound management Dietary advice Deep breathing exercises Coping skills

3rd session (4 weeks after the operation) Telephone (30 min)

- Discussion of issues arising after discharge

4th session (8 weeks after the operation) Group format with 2e3 patients (60 min)

1. General conditions after operation

2. Sexuality

3. Communication skills with family and friends 4. Social support networks

5. Social role changes

join a self-help group eight weeks after the operation. As the psychoeducational intervention program consisted of complex interventions with multiple sessions, giving the same amount of attention to both the intervention and control groups enabled the outcome variables to be distinguished as solely due to the interventional effect, and not the researcher’s attention (Beal et al., 2009). Data collection and statistical analysis Socio-demographic and clinical data were gathered during recruitment (time 1). Baseline data on outcome variables were also measured at time 1. Both groups of participants were then reassessed post-operatively and during the in-hospital period (time 2), and eight weeks after the operation (time 3). Well-validated quantitative outcome measures were utilized to assess sexual functioning, quality of life, uncertainty, anxiety, depression and social support.

Information provision, behavior therapy and psychological support



Sexual functioning was assessed by the Chinese version of the Sexual function-Vaginal changes Questionnaire (SVQ) at time 3. It consists of 20 core items measuring sexual and vaginal problems after treatment for gynecological cancer. Seven additional items compare current sexual functioning with pre-diagnosis. The 20 core items are grouped into five subscales: intimacy (IN), global sexual satisfaction (GS), sexual interest (SI), vaginal changes (VC) and sexual function (SF). The items in the IN, GS and SI are directed to all patients irrespective of partner availability and sexual activity. The other two subscales, VC and SF, are only applicable to sexually active respondents. Five subscale scores are provided with high scores indicating better sexual functioning (Chow et al., 2010). Quality of life was measured at two time points, times 1 and 3, with the use of the Traditional Chinese version of the Functional Assessment of Cancer Therapy-General (TCHI FACT-G) Version 4. The scale includes 27 items on 5-point Likert scales covering four domains of quality of life: physical (PWB), emotional (EWB), social (SWB) and functional well-being (FWB). In addition to four


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subscale scores, a total score ranging from 0 to 108 is provided with higher scores indicating a better quality of life (Lau et al., 2002). The Chinese version of the Mishel’s Uncertainty in Illness Scale (C-MUIS) was used to measure perceived uncertainty associated with gynecological cancer diagnosis and treatment in the study at times 1, 2 and 3. The C-MUIS consists of 33 items with a 5-point Likert scale divided into four subscales: ambiguity, complexity, inconsistency and unpredictability. Subscale and total scores are provided, with total score ranging from 33 to 165. Higher scores indicate higher levels of uncertainty (Taylor-Piliae and Molassiotis, 2000). The Chinese version of the Hospital Anxiety and Depression Scale (HADS) was used to assess anxiety and depression levels in the participants over the three time points. There is a total of 14 items in the scale which are equally distributed into anxiety and depression subscales. Higher scores reflect greater psychological distress (Leung et al., 1999). Perceived social support among the gynecological cancer patients was measured by the Chinese version of the Medical Outcomes Study Social Support Survey (MOS-SSS-C) at the three time points. The MOS-SSS-C is a 20-item scale with a 5-point Likert scale. There are 19 items representing four dimensions of social support in four subscales, including tangible support, affectionate support, positive social interaction and emotional-informational support. The remaining item assesses the size of the social network of close relatives and friends. Four subscale scores and the overall support index can be calculated, higher scores indicating more availability of social support (Yu et al., 2004). Qualitative data was collected from those participants in the intervention group and three nurses working on the study site. Interviewing the participants enabled to investigate the acceptability of the interventions, while interviewing the nurses aimed at determining the feasibility of implementing the interventions in clinical area and the potential for incorporating the program into clinical practice. All the interviewees were invited to have semistructured interviews to give their opinions and feelings concerning the interventions. The interview questions were “How do you feel about the interventions?”, “What is the usefulness of the interventions?”, and “Any suggestions for the interventions?” The interviews were conducted at time 3 for the intervention recipients and closest to the end of the study period for the nurses. All the interviews were conducted in group format with two to three participants together, and recorded on audio-tapes. All statistical analyses were performed on the basis of the intention-to-treat principle and missing data were imputed by the last observation carried forward method. Continuous demographic and clinical variables of the participants were summarized by their means and standard deviations, whereas categorical data were presented in frequencies and percentages. Given the small sample size, which made it difficult to justify the normality assumption of the continuous outcome variables, non-parametric inferential statistical tests including Mann-Whitney U and Kruskal-Wallis tests were used to analyze the quantitative data to assess interventional effects between the intervention and attention control groups (Polit, 2010). The results of the outcomes were reported as median scores with effect size calculated. All statistical tests were twotailed and the level of statistical significance was set at 0.05. Qualitative data were analyzed by content analysis. The recorded tapes were transcribed verbatim, and the transcripts were analyzed to identify themes and categories which were then translated into English. The themes and categories were reviewed by two researchers and an international scholar to improve accuracy. The equivalence of translation of the themes was also checked by the two researchers who were bilingual and familiar with qualitative study.

Results Participants’ recruitment flow and compliance Of the 30 eligible subjects invited to participate, 26 agreed and were randomly assigned into either the intervention or attention control group. Fig. 1 shows the details of recruitment and the flow of participants through the study. In the intervention group, the compliance rate was 69.2% and the attrition rate was 7.7%. Reasons given for not attending the fourth session of the program were returning to work, caring for a sick family member, and feeling tired due to chemotherapy. In the attention control group, the compliance and attrition rates were 46.2% and 0%, respectively. The reasons for not joining the self-help group were undergoing adjunctive therapy and the lack of companion.

Participant characteristics Among the 26 participants, six suffered from cervical cancer, 13 had uterine cancer and seven had ovarian cancer. The mean age was 54.5 years. The major diagnostic stage of the cancer was stage I (73.1%), and 50% of the participants had only been operated on as

Eligible patients N = 30

Recruited participants N = 26

Intervention group N = 13

Intervention group N = 13

Baseline (time 1)

Post-op (time 2)

Attended all sessions n=9

Attention control group N = 13

Attention control group N = 13

Received all attention n=6

Lost to follow-up (n = 1) Lost contact at time 3

Completed outcome

Post-op

Completed outcome

data N = 12

8 weeks (time 3)

data N = 13

Fig. 1. Recruitment of participants.


K.M. Chow et al. / European Journal of Oncology Nursing xxx (2014) 1e8 Table 2 Demographic and clinical characteristics of participants. Characteristics

Age (mean, SD) Education Less than primary Primary or secondary Tertiary or above Marital status Partnered Non-partnered Having children Yes No Type of gynecological cancer Cervical Uterine Ovarian Stage of gynecological cancer Stage I Stage II Stage III Treatment modality Operation only Operation þ adjuvant therapy

Intervention

Attention control

[n ¼ 13, f(%)]

[n ¼ 13, f(%)]

51.4 (8.0)

57.7 (13.4)

1 (7.7) 11 (84.6) 1 (7.7)

2 (15.4) 9 (69.2) 2 (15.4)

12 (92.3) 1 (7.7)

10 (76.9) 3 (23.1)

11 (84.6) 2 (15.4)

11 (84.6) 2 (15.4)

4 (30.8) 7 (53.8) 2 (15.4)

2 (15.4) 6 (46.2) 5 (38.5)

10 (76.9) 3 (23.1) 0 (0.0)

9 (69.2) 1 (7.7) 3 (23.1)

8 (61.5) 5 (38.5)

5 (38.5) 8 (61.5)

p-value

0.157a 0.680b

0.593b

0.999b

0.466b

0.205b

0.434b

Note. *p < 0.05. a Independent t-test. b Exact test.

the treatment modality for the disease. Homogeneity of participants in the intervention and attention control groups was tested by independent t-test and Exact test. There was no significant difference between the two groups with regard to their demographic and clinical characteristics at the baseline (Table 2). Outcomes The effectiveness of psychoeducational interventions on outcome variables was analyzed by comparing the results between

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the intervention and attention control groups. Furthermore, the trend of changes in the outcome variables between the groups was presented if the statistical significance (p < 0.05) could not be achieved with the small sample size. In comparing the baseline outcome variables of the two groups, no significant difference was found, except for the number of close friends. The intervention group had more close friends than the attention control group at baseline (median score: 2.0 vs. 0.0, p ¼ 0.018). With regard to the interventional effects on patient outcomes, there was no significant difference between the two groups in all outcome variables except uncertainty. There was a statistically significant difference found in the inconsistency subscale of the CMUIS between the two groups at time 2 (p ¼ 0.026). Participants in the intervention group had received less inconsistent information about the illness after the operation and during the in-hospital period when compared with baseline. In relation to trends of change, the intervention group demonstrated a better trend for improvement than the attention group in all subscales and the overall scale of C-MUIS. There was a significant effect size of 0.93 in the trend of improvement in the inconsistency subscale in the intervention group. However, there were contradictory results in the scales measuring quality of life, perceived social support, anxiety and depression (Table 3). The intervention group only demonstrated an insignificant small effect size of improvement in the subscales of EWB in TCHI FACT-G, affectionate support and positive social interaction in MOS-SSS-C, and depression in HADS (r ¼ 0.24 to 0.42). As sexual functioning was measured at only one time point, no trend of changes could be compared between the intervention and attention control groups. Of the 26 participants, only one participant was sexually active at data collection. Therefore, no comparison could be made in the two subscales, VC and SF, which are only applicable to sexually active respondents. Results found that there was no significant difference in the IN, GS and SI subscales of SVQ between the two groups at time 3.

Table 3 Summary of gynecological cancer patient outcome measures and change in outcomes. Time 1

Time 2

Time 2 e Time 1

Time 3

Time 3 e Time 1

Intervention Control Intervention Control Intervention Control Intervention Control ES TCHI FACT-G PWB subscale 20.0 SWB subscale 21.0 EWB subscale 14.0 FWB subscale 21.0 Total score 73.0 C-MUIS Ambiguity subscale 40.0 Complexity subscale 14.0 Inconsistency subscale 15.0 Unpredictability subscale 18.0 Total score 86.0 MOS-SSS-C No. of close relatives 3.0 No. of close friends 2.0 Tangible support subscale 87.5 Affectionate support 100.0 Positive social interaction scale 81.3 Emotional-informational support scale 62.5 Total score 85.9 HADS Anxiety subscale 5.0 Depression subscale 8.0 Total score 14.0

19.0 18.7 15.0 18.0 73.0

e e e e e

e e e e e

25.0 22.0 18.0 20.0 81.0

22.0 18.0 17.0 19.0 76.0

e e e e e

e e e e e

e e e e e

40.0 16.0 13.0 17.0 85.0

33.0 12.0 11.0 16.0 74.0

35.0 14.0 14.0 15.0 77.0

30.0 14.0 12.0 14.0 76.0

34.0 14.0 13.0 15.0 73.0

5.0 3.0 4.0 2.0 14.0

5.0 1.0 1.0 0.0 6.0

0.29 0.50 0.93* 0.31 0.68

2.0 0.0 81.3 91.7 68.8 43.8 66.9

3.0 3.0 93.8 100.0 93.8 68.8 86.7

2.0 0.0 75.0 91.7 75.0 53.1 73.7

5.0 3.0 87.5 100.0 93.8 75.0 88.3

3.0 2.0 81.3 75.0 56.3 43.8 64.3

0.0 0.0 6.2 0.0 12.5 9.4 5.5

0.0 0.0 0.0 0.0 6.2 6.2 0.3

7.0 5.0 12.0

3.0 6.0 8.0

1.0 7.0 8.0

2.0 5.0 9.0

1.0 5.0 8.0

2.0 0.0 4.0

6.0 1.0 8.0

Intervention Control ES 0.0 1.0 2.0 0.0 4.0

2.0 0.3 1.0 2.0 9.0

0.02 0.10 0.29 0.20 0.07

7.0 0.0 1.0 4.0 12.0

6.0 0.0 0.0 3.0 11.0

0.31 0.00 0.32 0.20 0.42

0.22 0.00 0.05 0.17 0.24 0.23 0.08

0.0 0.0 0.0 0.0 0.0 9.4 3.9

1.0 1.0 6.2 8.3 12.5 9.4 2.1

0.11 0.22 0.17 0.38 0.42 0.13 0.25

0.72 0.18 0.28

3.0 3.0 6.0

4.0 1.0 6.0

0.30 0.24 0.04

Data are presented as median, except the effect sizes (ES); *p < 0.05. ES: Cohen’d effect size (positive ES favors intervention, and vice versa).


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Feasibility of implementation From the perspective of the intervention recipients, the majority of them regarded the psychoeducational intervention program as offering emotional support and helpful for their psychological status. As participants said: “After meeting you (the researcher), I feel more psychologically comfortable and relaxed as my stress levels are reduced .” A few participants further acknowledged that the interventions would remove worries about their sexual life. One woman said: “Now, I know how my sex life will be after the operation. I don’t need to worry so much .” In addition, all the participants acknowledged the interventions provided informational support. They acquired knowledge of gynecological cancer and related treatments from the program. Examples include the following narratives: “I know more about the disease and impending treatment. I am not so worried about the side effects now .”, and “The knowledge prepared us psychologically for the operation, as unknown issue always cause anxiety and stress .” They also indicated the usefulness of relaxation breathing exercises during the post-operative period, “Whenever I can’t get to sleep, I remember what you taught me. For example, deep breathing exercises help me sleep better .” Some participants identified available resources in the community when financial difficulties were encountered. They said: “If I have financial problems, I know I can contact a social worker now. Actually, the government provides this type of assistance .” With regard to the design of the interventions, most participants considered it appropriate in its provision time frame, frequency and provider. For example, many participants stated: “The arrangement of the program is very good. Nothing needs to be revised .” Overall, the content of the information provided was adequate for most of the participants. However, one participant commented that postoperative care should be covered more thoroughly. She said that: “I want to know more. For example, the healing time for the abdominal wound, the duration of vaginal bleeding after the operation, and the feelings when stitches removal. These can help to relieve me of doubt and worries .” The majority of the participants had positive feelings towards the intervention program, as the following narrative depicted such feelings: “You (the researcher) help me a lot. I am so touched. The information and psychological support of the interventions are so important to me .” A few participants also commented about limited health education on gynecological cancer in the community. They said: “I don’t know about the signs and symptoms of the illness, and the need to have regular gynecological check-ups beforehand .” The intervention recipients’ opinions and feelings about the psychoeducational intervention program were categorized into four themes, summarized in Table 4.

Table 4 Themes developed from the qualitative data of intervention recipients. Emotional support Offering psychological support Removing worries about sexual life Informational support Acquiring knowledge on illness Behavior therapy helpful in post-operative care Resources available in the community Elements of the program Appropriate design of the interventions Content of information provided Feelings towards the program Appreciation of the interventions Lack of gynecological cancer health education in the community

Table 5 Themes developed from the qualitative data of health care providers. Opinions regarding the program Quality of information provided Usefulness of the interventions Suggestions for improvement Content of information provided Format of the interventions Coverage of the patient population Feasibility of implementing the program Anticipated barriers Solutions to the barriers

From the perspective of health care providers, all the nurses regarded the design of the program as appropriate in terms of the information provision. They said that: “The information is adequate for the patients. It is clear and detailed enough for them to have a basic knowledge of the disease .” They regarded the interventions as useful for newly diagnosed gynecological cancer patients, “The interventions are useful for newly diagnosed patients and can reduce their psychological distress. This also provides a channel for them to discuss sexual life, as patients usually feel embarrassed to ask direct questions about sex .” Suggestions were made to improve the interventions. Regarding the content of the information provided, they said: “It would be better to provide some web-sites related to gynecological cancer in the first individual session of the program, instead of the last session of group counseling. You know, the information is copious now, and patients can access it earlier if needed .” Further “You should provide more information about the services on sexuality provided by nongovernment organizations (NGOs). Hong Kong people hesitate to talk about sex in public, and it’s difficult to ask nurses to discuss this with patients in the ward. If information about NGOs is provided, patients can approach the related organizations for further sexual counseling, if needed .” Opinions about the format of the program were also given. One nurse said: “Involving the partner in the interventions may facilitate discussion of sexuality. The couples can discuss the topic openly and find solutions to sexual problems .” As the interventions were identified as useful for general gynecological patients, it was suggested “The interventions should be implemented phase by phase for coverage of a wider patient population.” Overall, all the nurses identified the implementation of the program as feasible and practical for gynecological cancer patients. However, a few barriers were foreseen: “The most important problem is shortage of manpower. Limited evidence on the effectiveness of the interventions on patient outcomes also makes it hard to fight for a budget. Inadequate training for nurses is another issue. If you can solve all the problems, it’s feasible to implement the interventions .” In order to remove the barriers, some solutions were identified by the nurses, “More research should be conducted to demonstrate the effectiveness of the interventions on gynecological cancer patients so that resources and budgets could be requested with evidence support. Then, further training could be provided for nurses to facilitate implementation of the interventions in clinical settings .” Views from health care providers on the psychoeducational intervention program and the feasibility of implementing it in the clinical settings were categorized into three themes, summarized in Table 5. Discussion Psychoeducational interventions for gynecological cancer patients are scarce in Hong Kong. An evidence- and theory-based psychoeducational intervention program is adopted in this pilot randomized controlled study. Results suggest that the program is feasible to be implemented for gynecological cancer patients in



clinical settings aims at improving their sexual functioning, quality of life, uncertainty, anxiety, depression and social support. In addition, a statistically significant improvement in the aspect of inconsistent information about the illness is demonstrated in the intervention group. Trends towards improvement are also shown in certain subscales measuring quality of life, perceived social support as well as depression in the intervention group although the findings are statistically insignificant. With adequate sample size in future study, it is expected that the outcomes will be more prominent. The psychoeducational intervention program was shown to be well accepted by the participants in the intervention group as evidenced by the qualitative interviews as well as high consent rate and low attrition rate. The consent rate for the study was 87%, with 26 participants agreed to participate in the study while 30 were invited. Even though the compliance rate for the psychoeducational intervention program was fair, 69.2%, the participants had compelling reasons for the absence from the last session. At the same time, they requested to receive the information covered in the missed session over the phone, and completed the data collection at all time-points. This indicated participants’ willingness to accept the program and stay in the study. In view of the feasibility of implementing such a program in clinical settings, the expression of views and feelings about the program by the intervention recipients and health care providers demonstrated the findings. Overall, the intervention recipients appreciated the provision of the interventions which prepared them psychologically for the treatment process and reduced their psychological distress. Health care providers’ opinions were consistent with those of the participants, affirming the interventions were useful for newly diagnosed gynecological cancer patients. Although Hong Kong Chinese people are known to be reticent talking about sex in public (Tang et al., 2010), the interventions provide chances for the participants to discuss this sensitive issue which is regarded as an important factor in marital satisfaction (Guo and Huang, 2005). With regard to the patients’ outcomes, a significant reduction in the inconsistency subscale of the C-MUIS was demonstrated in the intervention group from time 1 to time 2. According to the MUIS manual (Mishel, 1997), inconsistency means that the information changes frequently or is not congruent with what has been previously provided. In the study, the intervention group found the information about the illness and treatment provided before the operation to be congruent and consistent over time. In fact, patients always receive information from multiple sources such as friends, relatives, health care professionals and from websearching during the treatment process. Such information is likely to be inconsistent and causes confusion, but the psychoeducational intervention program during the treatment process clarifies the misconceptions and incorrect information the patients might have received. Thus, the participants had less inconsistent information about the illness after the completion of the operation. Meanwhile, improvement in inconsistency reduces uncertainty with the buildup of a knowledge base and familiarity with symptoms through education and social support from credible authority as supported by the Antecedents of Uncertainty theory (Mishel and Braden, 1988). It is recommended to measure uncertainty as a primary outcome in future trials to build up the knowledge base in this field. Although this study was not sufficiently powered to demonstrate the efficacy of the psychoeducational interventions in all outcome variables, the intervention group demonstrated better trends of improvement in emotional well-being of quality of life, affectionate social support, positive social interaction and depression over the attention control group. All of these indicated that the

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psychoeducational intervention program appears to be beneficial to the gynecological cancer patients. Major strengths of this study include: a randomized controlled trial with an attention control group which allows assessment of the interventional effects on patient outcomes, but excludes the possibility of the attention effect from the researcher, a collection of both quantitative and qualitative data to enrich the understanding of the interventions, and the use of reliable and valid outcome measures for data collection. In addition, the psychoeducational intervention program was an evidence-based practice which was designed according to the findings of a systematic review and the thematic counseling model. This makes a consistent and effective design for gynecological cancer patients. Future developments may consider incorporating the program into routine practice for gynecological cancer patients and evaluating its clinical effects on the patients. Certain limitations restricted the validity and generalizability of the study results. First, the use of non-parametric tests might underestimate the interventional effects causing type II error. Moreover, one study site limited the generalizability of the findings to the whole population of gynecological cancer patients in Hong Kong. Various types of gynecological cancer of the participants might not show the effect of the interventions towards a particular cancer group. Furthermore, blinding on randomization only might lead to the experimenter effect where the behavior of the intervener may unconsciously influences the participant’s response to the interventions or questionnaires (Portney and Watkins, 2009). There was also the possibility of contamination between the intervention and attention control groups because all the participants were admitted to the same ward and followed up at the same out-patient clinic. Finally, the long-term effects of the interventions on patient outcomes were not measured: especially the quality of life and sexual functioning which were expected to demonstrate the effects over a longer period of time. Findings of this pilot study support the value and feasibility of conducting a full-scale main study. Future studies would aim to recruit an adequate sample and blind the outcome assessor to reduce the bias of data collectors. To address the patients’ feedback in future trials, web-site information related to gynecological cancer will be provided in the first session. More information about the services on sexuality available in the community will be provided. Moreover, the involvement of partner in the interventions will be restricted to the first and second sessions only, as the presence of male partner in the last session which is a group format may induce embarrassment. In addition, the follow-up period should be extended to measure the long-term effects of the interventions among the patients. It is also necessary to recruit samples from hospitals in different regions of Hong Kong to make the participants more representative of the whole population. The program can also be tested in other countries to increase the generalizability of the psychoeducational interventions. Cost-effectiveness is an important issue needed to be addressed in the full-scale study. As mentioned by the health care providers in the interview, additional manpower is necessary to implement these interventions in clinical settings. Theoretically, this cost could be offset by the improved patient outcomes so that patients will utilize health care services less for the problems of psychological distress, sexual dysfunction and anxiety disorder. As a result, resource utilization and cost effectiveness of the program should be measured in future studies. Conclusions This pilot study demonstrates the feasibility and acceptability of implementing the psychoeducational intervention program for gynecological cancer patients in Hong Kong clinical settings. The


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program also appears to be effective in improving patient outcomes. We believe that this population of patients has unmet health care needs regarding the treatment trajectory, and nurses can take active roles to provide the care to fill the practice gap. The study warrants a full-scale investigation to confirm the findings. Conflict of interest statement There is no potential conflict of interest. Acknowledgements There are no acknowledgements. References Beal, C.C., Stuifbergen, A., Volker, D., Becker, H., 2009. Women’s experiences as members of attention control and experimental intervention groups in a randomized controlled trial. The Canadian Journal of Nursing Research 41, 16e31. Brotto, L.A., Heiman, J.R., Goff, B., Greer, B., Lentz, G.M., Swisher, E., et al., 2008. A psychoeducational intervention for sexual dysfunction in women with gynecologic cancer. Archives of Sexual Behavior 37, 317e329. Cain, E.N., Kohorn, E.I., Quinlan, D.M., Latimer, K., Schwartz, P.E., 1986. Psychosocial benefits of a cancer support group. Cancer 57, 183e189. Caldwell, R., Classen, C., Laganà, L., McGarvey, E., Baum, L., Duenke, S.D., et al., 2003. Changes in sexual functioning and mood among women treated for gynecological cancer who receive group therapy: a pilot study. Journal of Clinical Psychology in Medical Settings 10, 149e156. Campbell, M., Fitzpatrick, R., Haines, A., Kinmonth, A.L., Sandercock, P., Spiegelhalter, D., et al., 2000. Framework for design and evaluation of complex interventions to improve health. British Medical Journal 321, 694e696. 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, 347e357. Chan, C.W.H., Richardson, A., Richardson, J., 2012. Evaluating a complex intervention: a process evaluation of a psychoeducational intervention in patients receiving palliative lung cancer radiotherapy. Contemporary Nurse 40, 234e 244. Chow, K.M., Chan, C.W.H., Chan, J.C.Y., 2012. Effects of psychoeducational interventions on sexual functioning, quality of life, and psychological outcomes in patients with gynecological cancer: a systematic review. JBI Library of Systematic Reviews 10, 4077e4164. Chow, K.M., So, W.K.W., Chan, C.W.H., 2010. Assessing sexual function amongst Hong Kong Chinese patients with gynecological cancer: translation and validation of the Sexual Function-Vaginal Changes questionnaire (SVQ). Clinical Oncology and Cancer Research 7, 230e233. Gu, C., Chan, C.W.H., He, G.P., Choi, K.C., Yang, S.B., 2012. Chinese women’s motivation to receive future screening: the role of social-demographic factors, knowledge and risk perception of cervical cancer. European Journal of Oncology Nursing. http://dx.doi.org/10.1016/j.ejon.2012.04.005. Gu, C., Chan, C.W.H., Twinn, S.F., 2010. How sexual history and knowledge of cervical cancer and screening influence Chinese women’s screening behavior in Mainland China. Cancer Nursing 33, 445e453. Guo, B., Huang, J., 2005. Marital and sexual satisfaction in Chinese families: exploring the moderating effects. Journal of Sex & Marital Therapy 31, 21e29.

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