Copyright B 2015 Wolters Kluwer Health, Inc. All rights reserved.

Xiaobin Lai, PhD(c) Frances Kam Yuet Wong, PhD Carenx Wai Yee Leung, MBA Lai Ha Lee, MN Jessica Shuk Yin Wong, BN Yim Fan Lo, MN Shirley Siu Yin Ching, PhD

Development and Assessment of the Feasibility of a Nurse-Led Care Program for Cancer Patients in a Chemotherapy Day Center Results of the Pilot Study

K E Y

W O R D S

Background: The increasing number of cancer patients and inadequate

Chemotherapy

communication in clinics are posing challenges to cancer patients receiving

Nurse-led care

outpatient-based chemotherapy and healthcare providers. A nurse-led care program

Nurse’s practice patterns

was proposed as one way of dealing with at least some of these challenges.

Oncologic nursing

Objective: The objectives of the pilot study were to assess the feasibility of the subject recruitment, care, and data collection procedures and to explore the acceptability of this program. Methods: A pilot study with a 1-group pretest-posttest design was conducted. Five cancer patients receiving chemotherapy in a chemotherapy day center participated. Each patient had a nurse consultation before chemotherapy and received 2 telephone calls after the first and second cycles of chemotherapy. Four questionnaires were adopted to evaluate the subjects’ quality of life, self-efficacy, symptom experiences, and satisfaction with care. Questionnaires were completed before the chemotherapy and after the second cycle. The subjects were also interviewed to understand their comments on the service. Results: The recruitment, care, and data collection procedures were completed smoothly. Slight changes were observed in quality of life and self-efficacy. All 5 subjects were highly satisfied with the care. Conclusions: The nurse-led care

Author Affiliations: School of Nursing, the Hong Kong Polytechnic University (Ms Lai and Drs Wong and Ching); and Department of Clinical Oncology, Queen Elizabeth Hospital (Mss Leung, Lee, Wong, and Lo), Hong Kong. Author contributions: Study concept and design: Ms Lai and Drs Ching and Wong. Practice protocol development: Dr Ching and Mss Lai, Leung, Lee, and Wong. Care delivery: Mss Lee, Wong, and Lo. Analysis and interpretation of data: Ms Lai. Drafting the manuscript: Ms Lai. Critical revision of the manuscript: Drs Ching and Wong and Mss Leung and Lee. Study supervision: Drs Ching and Wong.

Nurse-Led Care Program in a Chemotherapy Day Center

This study was supported by Central Research Grant from the Hong Kong Polytechnic University (grant RU0Q). The authors have no conflicts of interest to disclose. Correspondence: Shirley Siu Yin Ching, PhD, School of Nursing, the Hong Kong Polytechnic University, Kowloon, Hong Kong, China ([email protected]). Accepted for publication June 23, 2014. DOI: 10.1097/NCC.0000000000000192

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program is feasible and acceptable. Implications for Practice: The effect of the nurse-led care program will be evaluated in a single-center, open, randomized controlled trial. If the encouraging results can be confirmed, it may be an effective approach to improving the quality of ambulatory chemotherapy care. It would also shed light on the development of nurse-led care in other areas. hemotherapy affects cancer patients in many ways.1 It is common that patients suffer multiple adverse effects simultaneously, such as mucositis, nausea and vomiting, altered appetite, skin changes, insomnia, pain, and fatigue.2Y4 Psychological distress is also a common problem during chemotherapy.5 Distressful experiences in chemotherapy may lead to deterioration in a patient’s of quality of life (QOL).6 Chou et al7 report that the QOL of cancer patients during chemotherapy is low to moderate. In addition, cancer patients have particularly high unmet needs during treatment, including informational needs, psychosocial needs, needs in the activities of daily living, supportive care needs, sexual needs, and communication needs.8 Among them, information is the most frequently reported need in the treatment phase.9,10 These unmet needs cause uncertainty, anxiety, and distress to cancer patients.11 Outpatient-based chemotherapy is now widely established. Despite its benefits to healthcare institutions and cancer patients, there are attendant challenges. Cancer patients need to take care of themselves at home during each interval of chemotherapy. They feel lack of support from healthcare providers, which causes their distress levels to rise.12 Without adequate support from healthcare providers, cancer patients may not be able to properly manage chemotherapy and its effects by themselves. The poor management of adverse effects may lead to increased healthcare utilization. Baena-Canada et al13 reported that 42.2% of breast cancer patients require more than 1 unscheduled healthcare encounter during chemotherapy. Cancer patients need to develop new selfcare skills to cope with chemotherapy. Providing essential information and skills to cancer patients can increase their knowledge and control treatment-related symptoms better.14,15 Self-efficacy is believed to be an important factor in illness adaptation and self-care behaviors.16 Previous studies support the view that improvements in self-efficacy are positively related to illness adjustment, health behaviors, symptom control, and QOL.16Y19 However, the self-efficacy of cancer patients may fall during chemotherapy.20 Interventions targeting self-efficacy may promote self-care behaviors among cancer patients and facilitate their adaptation during chemotherapy. Facing increasing numbers of cancer patients and burgeoning healthcare needs, healthcare professionals must address the issue of how to improve the quality of care during chemotherapy. During the past years, the practice of oncology nursing has advanced under the wave of innovations in the whole discipline of nursing. Nurseled care is a highly recommended and innovative way of improving quality of care.21 It shows distinct advantages in terms of providing holistic care because it is based on the philosophy of the uniqueness of individuals and the multidimensionality of human beings.22 The feasibility and effects of nurse-led care are being explored in an increasing number of studies. There have been a

C

few studies of nurse-led care for cancer patients receiving outpatientbased chemotherapy.23Y26 Among these, only 2 adopt a strict study design to examine its effects. Thus, there is a need to examine the feasibility and effects of nurse-led care for cancer patients receiving chemotherapy in outpatient settings. Therefore, a nurse-led care program for cancer patients receiving chemotherapy in an outpatient setting was formulated. The aim of the study was to assess the effect of this nurse-led care program on cancer patients who received neoadjuvant/adjuvant chemotherapy in a chemotherapy day center in terms of QOL, symptom experiences, self-efficacy, healthcare utilization, and satisfaction with care. This article reports the development of the nurse-led care program and the pilot study. The pilot study adopted a 1-group pretest-posttest design, the aim of which was to assess the feasibility of the subject recruitment procedure, care procedure, and data collection procedure and to explore the acceptability of this nurse-led care program.

Conceptual Framework of the Study Undergoing chemotherapy is a process that changes over time,12 which can be regarded as one of the transitions in the whole cancer journey. The commencement of chemotherapy triggers a new start for cancer patients. They seek information and self-care skills to get themselves psychologically ready for the coming treatment. They learn to practice these skills to relieve the multidimensional impacts of chemotherapy. Meanwhile, cancer patients engage in the reframing process to adjust the impact of cancer psychologically.27 After the initial shock, they begin to actively use strategies to make senses of their situation in the prolonged adjuvant treatment.28,29 As the chemotherapy proceeds, they move toward a greater degree of acceptance.27Y29 The nurse-led care program was developed based on Bridges’30 transition theory and Meleis’ transition theory31 (Figure 1). Transition refers to passage from one life phase, condition, or status to another. Three phases are involved: entry, passage, and exit.30 The success of the transition is affected by personal and environmental factors.31 Personal factors include awareness, engagement, meaning, confidence, and preparation and knowledge; environmental factors consist of social support, organizational support, and social cultural environment.31 Healthy transitions will lead to (1) subjective sense of well-being, (2) mastery of new behaviors, and (3) the well-being of interpersonal relationships.31 In this study, undergoing chemotherapy was regarded as a transition for cancer patients in their cancer journey. The aims of the nurse-led care program were to ease the transition caused by chemotherapy and enhance the well-being of cancer patients. Nursing interventions targeted the essential personal and environmental factors mentioned above, in the hope that cancer patients could

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Figure 1 n The conceptual framework of the nurse-led care program. Abbreviations: OPD, outpatient department; QOL, quality of life. maintain a sense of well-being and good interpersonal relationships and master self-care strategies to cope with the impacts of chemotherapy.

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Methods

an appointment and prepared documents for a chemotherapy injection. Finally, the nurse gave the patient brief instruction, including the arrangement on the day of the chemotherapy injection and simple self-care skills. Subject recruitment was conducted on the day of the prechemotherapy medical consultation. One of the researchers recruited subjects when nurses booked appointments and prepared documents.

A 1-group pretest-posttest design was adopted in the pilot study.

The Nurse-Led Care Program

Subjects and Setting

The nurse-led care program consisted of a prechemotherapy nurse consultation and telephone follow-ups during chemotherapy (Figure 2). All interventions were conducted according to 4 evidence-based practice protocols developed for the study (Figure 3). The first one (ie, the Overall Status Evaluation Tool) was a scale of 0 to 10 points for evaluating the overall status of the subjects in each intervention session. The protocol for the face-to-face nurse consultation (ie, the Nursing Practice Protocol) was composed of 30 problems in 4 domains: physiological, psychosocial-spiritual, health-related behavior, and environmental domains. The other 2 protocols were designed for telephone follow-ups. One was to screen and triage the severities of 13 common problems in chemotherapy (ie, the Symptom Screening and Triage Tool), and another was for care delivery and instructions targeted at the 13 problems (ie, the Telephone Follow-up Protocol). All of the protocols were developed based mainly on information provided by the BC Cancer Agency, the National Cancer Institution, the National Comprehensive Cancer Network, the Oncology Nursing Society, and the UK Oncology Nursing Society. The weight-of-evidence classification proposed by the Oncology Nursing Society was adopted in the protocols.33 Interventions rated as levels I (recommended for practice), II (likely to be effective), and VII (expert opinions) were included in the protocols. The content validity of the protocols was evaluated by a panel of 5 experts before the start of the study, including 1 oncologist, 1 nursing researcher, 1 nurse manager, and 2 experienced oncology nurses. The content validity index was 1 for the Overall Status Evaluation Tool, 0.97 for the Overall

The pilot study was conducted in the chemotherapy day center of a public hospital in Hong Kong. It is 1 of 6 chemotherapy day centers in Hong Kong public hospitals that provide an outpatientbased chemotherapy service. The inclusion criteria of subjects included (a) being 18 years or older, (b) diagnosed with primary breast cancer or colorectal cancer, (c) receiving chemotherapy for the first time, (d ) Karnofsky Performance Scale (KPS) score 60 or greater, (e) communicating in Cantonese and reading Chinese, and (f ) can be contacted by telephone. The exclusion criteria included (a) having a history of psychiatric or intellectual impairment such as dementia, schizophrenia, mental retardation, depression, and anxiety disorder; (b) having chemotherapy before; (c) receiving concurrent chemoradiotherapy; and (d ) being at the end stage of life. Subjects would be withdrawn from the study in the event of a change in their chemotherapy scheme. The rationale for recruiting patients with breast or colorectal cancer was because new cases involving these 2 types of cancer have contributed significantly to the increase in the number of cancer cases in Hong Kong.32 Breast cancer or colorectal cancer patients in Hong Kong receive chemotherapy mainly in outpatient settings. The plan was to recruit 12 subjects in the pilot study during the 3-week recruitment period. In the study hospital, cancer patient had a medical consultation with an oncologist to decide whether to receive chemotherapy. Once the treatment plan was confirmed, it was checked by another oncologist and a pharmacist. Then, the nurse booked

Nurse-Led Care Program in a Chemotherapy Day Center

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Figure 2 n The flowchart of the nurse-led care program and the pilot study. Abbreviation: QOL, quality of life. Status Evaluation Tool, 0.94 for the Symptom Screening and Triage Tool, and 0.94 for the Telephone Follow-up Protocol. A prechemotherapy nurse consultation was arranged on the day of the first cycle before the drug injection, which was after the brief prechemotherapy instruction (Figure 2). The contents included (Figure 3) a review of the subject’s medical history, an assessment of healthcare needs, the provision of information on chemotherapy, and psychological support. Possible referrals were made to other healthcare professionals/departments, such as oncologists, medical social workers, or cancer patient resource center

if subjects had problems beyond the responsibility of the intervention nurses. In the main study, telephone follow-ups would be delivered after the first, second, fourth, sixth, and eighth cycles (Figure 2). Each telephone call would be delivered within 1 week following the day of drug injection. In the pilot study, telephone follow-ups were delivered after the first and second cycles. Each telephone follow-up consisted of 3 components (Figure 3): (1) assessment and triage: the overall status of the subject was evaluated, and the 13 chemotherapy-related problems were triaged at 4 levels: (i) red

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Lai et al

Figure 3 n Nurse-led care procedure and practice protocols. label: severe problems necessitating an immediate trip to the emergency room; (ii) yellow label: moderate problems requiring a consultation with the intervention nurse. A referral would be made afterward, if necessary; (iii) blue label: problems that can be monitored at home for 24 hours. An extra telephone call would be made on the next day to assess whether there were any changes in the problems; (iv) green label: mild problems that could be managed at home. (2) Care delivery: Home care instruction on the problems with blue/green labels was given to the subjects. (3) Evaluation: The changes in the problems were evaluated at the beginning of the next telephone call from 3 aspects: knowledge about the problem (K), self-care behavior for the problem (B),

Nurse-Led Care Program in a Chemotherapy Day Center

and the status of the problem (S). The Problem Rating Scale for Outcomes in the Omaha system was adopted for this evaluation.34 The KBS of each problem was evaluated on a scale of 1 to 5: 1 meant ‘‘no knowledge/no appropriate behavior/extreme sign or symptoms,’’ 5 meant ‘‘superior knowledge/consistently appropriate behavior/no signs or symptoms.’’ The Omaha system was adopted as the documentation system in this study. It is a comprehensive classification to document client needs, practitioner interventions, and client outcomes, consisting of 3 parts: the Problem Classification Scheme, the Intervention Scheme, and the Problem Rating Scale for Outcomes.34 To facilitate the procedure of documentation, 2 Office Excel files were Cancer NursingTM, Vol. 38, No. 5, 2015

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developed. The first Excel file (file A) was to record care for individual subjects. It consisted of 4 parts: (a) a record sheet of basic information, such as the intervention date, duration, overall status, and symptom triage results; (b) a record sheet of problems and outcomes; (c) record sheets of interventions; (d ) a summary sheet for individual subjects. The second Excel file (file B) was a data set of the data of all subjects, which was automatically extracted from file A. The nurse consultation and telephone follow-ups were conducted by nurses in the hospital. The eligibility criteria for the intervention nurses were (1) a high diploma degree in nursing or greater and (2) more than 5 years of experience in oncology settings. Finally, 3 advanced practice nurses who had worked in the oncology department for 10 to 17 years were the intervention nurses. Before the study began, the 3 intervention nurses received training to ensure that they were familiar with the conceptual framework, protocols, care procedures, and documentation procedures. The care delivery process was standardized as well. A scenario comprising a nurse consultation and 2 telephone follow-ups was used to assess the intervention fidelity and the interrater reliability of problem outcomes among the 3 nurses. An intervention fidelity checklist was developed based on the checklist used in Bakitas and colleagues’ study.35 The average intervention fidelity of 9 sessions after training was 84.3%. The interrater reliability of the KBS scores of the simulated patient’s problems was calculated. The intraclass correlation coefficients (3,3) were 0.90 for knowledge (95% confidence interval [CI], 0.58Y0.99; P = .001), 0.69 for behavior (95% CI, j0.31 to 0.99; P = .054), and 0.998 for status (95% CI, 0.94Y1.00; P G .001).

Outcome Measures The outcomes of the pilot study included QOL, symptom experiences, self-efficacy, satisfaction with care, and the subjects’ comments on the nurse-led care program. QUALITY OF LIFE

The primary outcome of the study was QOL, which was assessed by the Chinese version of the Functional Assessment of Cancer TherapyYGeneral Scale (FACT-G).36 It comprises 27 items in 4 subscales: the physical, emotional, social, and functional wellbeing. Each item is rated on a scale of 1 to 4. Each subscale has a total score. The total score of the entire questionnaire is the sum of the subscale scores. A higher score represents better QOL. A 5-point change in the FACT-G total score and a 2-point change in the subscale score are considered as clinically meaningful differences.37 The Cronbach’s " of the Chinese version is .85.38 SYMPTOM EXPERIENCES

Symptom experiences included the incidence of symptoms and the distress levels of the symptoms, as assessed by the Chemotherapy Symptom Assessment Scale (CSAS).39 Provided by one of the developers of the questionnaire (C. Dikken), the modified CSAS consisting of 22 items was adopted. Subjects answered if they had experienced any of the symptoms since the last chemo-

therapy cycle. If a symptom was present, then the distress level of the symptom would be rated on a scale of 0 to 3 (0 = not at all; 3 = very much). The Cronbach’s " of the English version is .82.40 The questionnaire was translated into Chinese by one of the researchers.41 SELF-EFFICACY

Self-efficacy was assessed by the Strategies Used by People to Promote Health Scale (SUPPH).42 The Strategies Used by People to Promote Health Scale is a 29-item scale to measure the selfefficacy of cancer patients, including 2 factors: the physiological factor and the performance factor.43 Each item is rated on a scale of 1 to 5. The total score of SUPPH is the sum of the scores for all items. A higher score represents higher self-efficacy. The Chinese version of SUPPH translated by Qian and Yuan44 was adopted in the study. The Cronbach’s " of the Chinese version is .97. SATISFACTION WITH CARE

Satisfaction with care was evaluated using a self-designed questionnaire. There were a total of 29 items in the questionnaire. The first 26 items were rated on a scale of 1 to 4 (1 = totally unsatisfied, 4 = totally satisfied). Two items were in multiple-choice format. The last item evaluated the subjects’ overall satisfaction with care on a scale of 0 to 10. A higher overall score represented higher satisfaction with care. COMMENTS FROM SUBJECTS

A structured interview was used to understand the subjects’ comments on the service. The subjects were interviewed individually when they completed the pilot study.

Data Collection Data were collected before chemotherapy (T0) and after the second cycle of chemotherapy (T1). The questionnaires, FACT-G, CSAS, and SUPPH, were filled out at both T0 and T1 by the subjects themselves. The satisfaction with care questionnaire was completed at T1. Interviews were conducted after the subjects completed the questionnaire at T1.

Date Analysis Data collected by the questionnaires were analyzed using Predictive Analysis SoftWare 19 (IBM, New York). Data for 1 subject at both T0 and T1 were missing. This subject was excluded from the data analysis. All variables were first presented by appropriate descriptive statistics. Further analyses were carried out using nonparametric statistics because of the small sample size. The differences in QOL and self-efficacy over time were analyzed using the Wilcoxon signed rank test. The McNemar test was adopted to compare the incidence of symptoms at 2 time points. The Wilcoxon signed rank test was adopted to compare the distress level of each symptom at 2 time points. The interviews were recorded and transcribed verbatim in Cantonese. Content analysis was used to analyze the contents of interviews.

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Results

Recruitment Procedure The pilot study was conducted between June and August 2012 after approval was obtained from the university and the hospital ethics committees. The recruitment procedure was completed as planned. During the 3-week recruitment period, the medical records of 24 patients were reviewed. Ten patients failed to meet the subject criteria; 5 eligible patients were excluded because they joined another research project; and 3 eligible patients refused to join. The reasons for refusal included great stress (n = 2) and unwillingness to fill out questionnaires (n = 1). In the end, 6 patients joined the study. One subject withdrew after the first cycle because his chemotherapy scheme was changed due to the progression of his disease.

of chemotherapy, 1 or 2 days after the medical consultation. One reason for this was that there was not enough time for subjects to complete all of the questionnaires before the brief instruction. Another reason was that the subjects preferred to fill out the questionnaires at home because they felt calmer and more comfortable at home. The questionnaires at T1 were completed according to the original plan. A medical consultation was arranged 1 or 2 days before the next cycle of chemotherapy. On that day, cancer patients took a blood test in the morning and saw an oncologist, who would determine whether the next cycle can be continued based on the patient’s condition and blood test results, in the afternoon. The T1 questionnaires were filled out on the morning of the day of the medical consultation before the third cycle, after the subjects took a blood test. One of the researchers then interviewed them to obtain their comments.

Patient Outcomes

Care Delivery Procedure Each intervention nurse delivered care to 2 subjects. The prechemotherapy nurse consultations were conducted on the day of the first cycle before the drug injection was administered. Telephone follow-up sessions were delivered after the first and the second cycles within 7 days following the day of the drug injection. Extra telephone calls were delivered according to the practice protocols. In total, 6 prechemotherapy nurse consultations and 13 telephone calls were delivered by the 3 intervention nurses. The average duration of the nurse consultations was 35.5 minutes (range, 30Y51 minutes). The average duration of the telephone calls was 12.2 minutes (range, 5Y24 minutes). All scheduled telephone calls were conducted within 1 week. Two extra telephone calls were delivered to 2 respective subjects after the first cycle. The intervention nurses found that making an extra telephone call on the next day was not of much help to subjects with fatigue or sleep difficulties, because the subjects needed more days to practice new strategies and examine the effect. The intervention fidelity in the pilot study was 88.7%. All intervention sessions were recorded in the computerized Omaha system. Before the nurse consultations, the subjects had an average of 9 health-related problems, dropping to 2 after the second cycle. The average knowledge score of the subjects increased from 1.01 to 2.40, and the average behavior score increased from 1.02 to 2.31, indicating an improvement in knowledge and behavior. The average status score of the subjects fell from 4.96 to 3.99, indicating that the problems became worse after the start of chemotherapy.

Data Collection Procedure Of the 6 subjects, 5 completed the questionnaires. Data collection at T0 differed somewhat from the original plan. Instead of completing the baseline questionnaires after recruitment on the day of the prechemotherapy medical consultation, subjects completed the questionnaires at home after the medical consultation and brought the questionnaires back on the day of the first cycle

Nurse-Led Care Program in a Chemotherapy Day Center

The median age of the 5 subjects was 59 years (range, 42Y69 years). Their demographic characteristics are listed on Table 1 and clinical characteristics on Table 2. One subject was a 66-year-old male patient with stage IV stomach cancer. He received palliative chemotherapy (XELOX [oxaliplatin + capecitabine] scheme). The other 4 were female subjects with breast cancer. One (who was 46 years old) received 4-cycle adjuvant chemotherapy (AC [doxorubicin + cyclophosphamide] scheme). Two (who were 42 and 55 years old) received 6-cycle adjuvant chemotherapy (TAC [docetaxel + adriamycin + cyclophosphamide] scheme and PACS01 [5-fluorouracil+ epirubicin + cyclophosphamide, 3 cycles, then docetaxel 3 cycles] scheme). The last breast cancer subject (who was 63 years old) received 8-cycle neoadjuvant chemotherapy (AC-T [doxorubicin + cyclophosphamide, 4 cycles, then docetaxel 4 cycles] scheme). The subject with XELOX scheme and the subject with AC-T scheme finished primary school education; the other 3 subjects finished secondary school education. Four subjects could be cared for by family members except the one with PACS01 scheme. The QOL of the 5 subjects at 2 time points is presented at Table 3. Although no significant changes were found, clinically meaningful differences were found in the overall QOL and 4 subscales. The overall QOL of 1 subject (20%) at T1 was clinically worse than at T0, and the physical well-being of 3 subjects (60%) at T1 was clinically worse. By contrast, the emotional wellbeing of 3 subjects (60%) at T1 was clinically better. Both clinical improvement and deterioration were observed simultaneously in the social and functional domains. The social well-being of 2 subjects (40%) improved clinically, whereas 1 subject (20%) deteriorated clinically. The functional well-being of 4 subjects (80%) at T1 was clinically worse, whereas the other one was clinically better. The self-efficacy of the 5 subjects is shown in Table 4. The scores for the overall self-efficacy (95 vs 86), physiological selfefficacy (73 vs 66), and performance self-efficacy (73 vs 66) at T1 were slightly higher than at T0, but no significant differences were found. In terms of symptoms, a few symptoms were reported at T0 (Table 5). After 2 cycles (T1), more symptoms were reported; Cancer NursingTM, Vol. 38, No. 5, 2015

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Table 1 & Demographic Characteristics at Baseline (T0) Characteristics Gender Female Male Educational background Primary Secondary Tertiary Occupation Full-time job Part-time job Staying at home Religion None Buddhist Christian Marital status Widowed Married/cohabiting

n (%) 4 (80.0) 1 (20.0) 2 (40.0) 3 (60.0) V 2 (40.0) V 3 (60.0) 3 (60.0) 1 (20.0) 1 (20.0) 1 (20.0) 4 (80.0)

Characteristics

n (%)

Living arrangements Alone With family members Primary caregiver Self Spouse/partner Parents Others Monthly family income 9HK$9999 HK$10 000Y19 999 HK$20 000Y29 999 9HK$30 000 Payment of medical expenses Government subsidy Medicare coverage Self-financed Difficulties in making payment

V 5 (100) 1 2 1 1

(20.0) (40.0) (20.0) (20.0)

1 (20.0) 2 (40.0) V 2 (40.0) 4 (80.0) V 1 (20.0) 1 (20.0)

Abbreviation: HK$, Hong Kong dollars.

the most common ones were hair loss (100%), fatigue (100%), appetite change (80.0%), and weight change (80.0%). For the symptoms reported both at T0 and T1, the incidence and distress levels did not differ significantly. All 5 subjects expressed high satisfaction with the nurse-led care. The average score for overall satisfaction was 9.4 (range, 8Y10). The average score for the first 26 items was 3.76. Most of the subjects thought that all of the nursing interventions were useful (Table 6). According to the interviews, all 5 subjects thought that they benefited from the service. The prechemotherapy nurse consultations provided them with an opportunity to raise their concerns and obtain adequate information on the upcoming chemotherapy. The subjects felt less nervous and anxious after knowing what may happen during the treatment and what they could do to handle the problems: Chatting with the nurse helped me a lot. I was bothered by some questions at that time. I asked the nurse, and she answered. It really released me of my nervousness, unhappiness, and stress. (P03) I could know more about the whole situation and expected what would happen to me. So I was not so scared when I received the drug injection. I could remember some ways to resolve the problems easily when it happened. (P04) The prechemotherapy nurse consultations helped the subjects psychologically ready to face the upcoming chemotherapy treatment. Similar to the prechemotherapy nurse consultations, all of the subjects pointed out that the telephone follow-ups were helpful as well. The telephone follow-ups played several important roles. A patient may not fully remember the information on adverse effects and self-care strategies when suffering multiple adverse effects simultaneously. The telephone calls served as reminders. The

subjects could recall some strategies after discussing with the nurses over the telephone: Although I got some leaflets before chemotherapy, I didn’t want to read them when I was very uncomfortable. At that time, the nurse’s call was like a reminder. I could remember some methods of managing my discomforts when chatting with her. These methods made the tough days easier. (P01) The intervention nurses also gave the subjects further suggestions after the comprehensive assessment: The nurse called and assessed my condition very carefullyI. She would introduce some methods if I had some problems. After the first cycle I had

Table 2 & Clinical Characteristics at Baseline (T0)

Characteristics Past health history None One disease Diagnosis Breast cancer Stomach cancer Disease stage I II III IV

n (%) 2 (40.0) 3 (60.0) 4 (80.0) 1 (20.0) 1 1 2 1

(20.0) (20.0) (40.0) (20.0)

Characteristics Chemotherapy intent Neoadjuvant Adjuvant Palliative Chemotherapy scheme AC PACS01 TAC XELOX AC-T

n (%) 1 (20.0) 3 (60.0) 1 (20.0) 1 1 1 1 1

(20.0) (20.0) (20.0) (20.0) (20.0)

Abbreviations: AC, doxorubicin + cyclophosphamide, 4 cycles; AC-T, doxorubicin + cyclophosphamide, 4 cycles, then docetaxel 4 cycles; PACS01, 5-fluorouracil+ epirubicin + cyclophosphamide, 3 cycles, then docetaxel 3 cycles; TAC, docetaxel + adriamycin + cyclophosphamide, 6 cycles; XELOX, oxaliplatin + capecitabine, 8 cycles.

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Table 3 & The Quality of Life Scores of the Subjects (n = 5) Variables

T0 Median (Min, Max)

Physical well-being Social well-being Emotional well-being Functional well-being Overall quality of life

24.0 22.0 16.0 21.0 83.0

(22.0, (16.0, (12.0, (15.0, (80.0,

T1 Median (Min, Max)

28.0) 26.0) 22.0) 26.0) 87.0)

22.0 21.0 20.0 18.0 80.7

(19.0, (18.7, (17.0, (13.0, (72.0,

27.0) 26.0) 22.0) 21.0) 91.3)

Z

Pa

j1.604 j1.095 j1.604 j1.361 j0.680

.109 .273 .109 .174 .496

a

Wilcoxon Signed-rank test. T0 = before chemotherapy. T1 = after second cycle of chemotherapy. Z = Z score.

constipation, so the nurse suggested eating foods containing fiber to me. I found that these foods were really helpful. (P01) The subjects thought that information on their possible progress over time was useful. They felt less nervous after knowing what to expect: After I had the first drug injection, the nurse told me what would happen as time went by. It allowed me to understand the whole process gradually so that I was not so scared and bothered. (P03) As the chemotherapy sessions progressed, the nurses’ call cleared up their confusion in time: What I really experienced after chemotherapy was different from what I expected, so I had new questions. At that time, I got answers and solutions in time when the nurse called me. (P05) Besides useful information, the subjects were touched by the nurses’ caring behaviors: I was so moved by her detailed and careful assessment. (P05) They thought that the intervention nurses were caring and responsible. All of the subjects hoped that the service could be enlarged to benefit more patients. Regarding the frequency of telephone follow-ups, 4 subjects thought that 2 telephone calls were adequate considering the limited human resources in public hospitals. To ensure that more patients could use the service, 2 telephone calls was a reasonable option. One subject thought that 2 telephone calls were not enough for a course of chemotherapy consisting of 6 cycles. Changes in their conditions may occur along

the course of treatment. All of the subjects thought that the timing of the telephone calls was appropriate.

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Discussion

This pilot study demonstrated that the nurse-led care program for cancer patients receiving outpatient-based chemotherapy was feasible and acceptable. Generally, the recruitment procedure was feasible. However, the number of subjects recruited in the pilot study was fewer than in the original plan, especially subjects with colorectal cancer. One important reason for this was the strict subject criteria. Rectal cancer patients who needed chemoradiotherapy were excluded to avoid complex effects, leading to a certain proportion of patients failing to meet the criteria. Therefore, 1 stomach patient was recruited because the adjuvant chemotherapy for stomach cancer in the study hospital was the same as that for colorectal cancer. In addition, a few patients were excluded because of illiteracy. Another reason was the implementation of another research program in the hospital. The subjects of the research program were also patients with breast cancer or colorectal cancer. Considering the possible confounding effect if patients were enrolled in both programs, patients who joined that research program were excluded from the pilot study. Based on the experience with recruitment in the pilot study, minor revisions were made to the subject criteria. Eligible patients with lung cancer or stomach cancer will also be recruited in the main study. The chemotherapy for lung cancer is similar to that for breast cancer. They are 4-cycle chemotherapy schemes that are administered every 3 weeks. Patients with distance metastases (stage IV) will be excluded, because their health condition

Table 4 & The Self-efficacy Scores of the Subjects (n = 5) Variables Physiological self-efficacy Performance self-efficacy Overall self-efficacy

T0 Median (Min, Max)

T1 Median (Min, Max)

Z

Pa

66.0 (48.0, 108.0) 20.0 (14.0, 34.0) 86.0 (64.0, 142.0)

73.0 (43.0, 110.0) 22.0 (15.0, 35.0) 95.0 (58.0, 145.0)

j0.674 j0.135 j0.674

.500 .893 .500

a Wilcoxon Signed-rank test. T0 = before chemotherapy. T1 = after second cycle of chemotherapy. Z = Z score.

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Table 5 & Symptom Incidence and Distress Levels Incidence Variables

n (%)

1. Nausea/vomiting before treatment 2. Nausea following treatment 3. Vomiting following treatment 4. Mouth/throat problems 5. Appetite changea 6. Weight change/anorexiaa 7. Constipation 8. Diarrhea 9. Hair loss 10. Fatiguea,b 11. Paina,b 12. Signs of infection 13. Bleeding/bruising 14. Pins and needles/numbness of hands and feet 15. Difficulty sleeping 16. Headaches 17. Shortness of breatha 18. Skin/nail problemsa 19. Eye problemsa 20. Distressful feelinga,b 21. Changes in intimate or sexual relationshipsa

T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1

0 1 0 2 0 2 0 2 1 4 1 4 0 3 1 3 0 5 2 5 2 3 0 3 0 1 0 3 0 2 0 1 1 1 1 3 1 1 3 3 2 2

(0) (20) (0) (40) (0) (40) (0) (40) (20) (80) (20) (80) (0) (60) (20) (60) (0) (100) (40) (100) (40) (60) (0) (60) (0) (20) (0) (60) (0) (40) (0) (20) (20) (20) (20) (60) (20) (20) (60) (60) (40) (40)

Distress level 0

1

2

3

V 1 (20) V 1 (20) V 1 (20) V 1 (20) 1 (20) V V V V V 1 (20) 1 (20) V V 1 (20) 1 (20) 2 (40) V V 1 (20) V 1 (20) V V V V V V 1 (20) V 1 (20) 1 (20) V V V V V V

V V V V V 1 (20) V V V 2 (40) 1 (20) 4 (80) V 2 (40) V 2 (40) V V 1 (20) 1 (20) V 3 (60) V 2 (40) V V V 2 (40) V 2 (40) V 1 (20) V 1 (20) V 2 (40) 1 (20) 1 (20) 2 (40) 3 (60) 1 (20) 1 (20)

V V V 1 (20) V V V 1 (20) V 2 (40) V V V 1 (20) V V V V V 3 (20) V V V V V V V 1 (20) V V V V V V V V V V V V 1 (20) 1 (20)

V V V V V V V V V V V V V V V V V 3 (60) V V V V V V V V V V V V V V V V V V V V 1 (20) V V V

0: Not at all; 1: A little; 2: Quite a bit; 3: Very much. a The incidence of symptoms at 2 time points was compared using the McNemar test. b The distress levels of symptoms were compared using the Wilcoxon Signed-rank test. T0 = before chemotherapy. T1 = after second cycle of chemotherapy.

or treatment plan may change before the completion of the study. In addition, the recruitment period of the main study will be extended to include as many subjects as possible. The practice protocols of the nurse-led care were successfully adopted. All 3 intervention nurses delivered the care according to the protocols. A minor adjustment to the symptom triage process was made after the pilot study. The intervention nurses found that it would be better to make an extra telephone call a few days

after the scheduled one if the patient was experiencing problems such as fatigue, sleep difficulties, or psychological distress, because a longer time may be needed before there could be improvements in their condition. As a clinical trial involving care delivered by frontline nurses, it was essential to consider the workload of the intervention nurses in this study. In this pilot study, the intervention nurses were able to deliver all of the intervention sessions. The duration of the prechemotherapy consultations and the telephone

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Table 6 & Subjects’ Feedback on Nursing Interventions Interventions 1. 2. 3. 4. 5. 6.

Useful, n (%)

Assess patient’s concerns and worries Information about chemotherapy and adverse effects Resolving other problems Advice about health-related needs in daily life Psychological support Other (‘‘The nurses really cared about me.’’)

follow-ups was feasible and acceptable. However, considering the possibility that the workload will increase in the main study, the maximum recruitment quota for each week was decided after a discussion with the intervention nurses. Adherence to the practice protocols is essential for good results. Several strategies were followed to ensure the quality of care. All intervention nurses received training so that they could deliver a standardized care procedure and became familiar with the protocols. High intervention fidelity and interrater reliability in the knowledge and status evaluation were achieved before the start of the pilot study. Only the interrater reliability of the behavior evaluation was low. The main reason for this was the difficulty of establishing standard criteria to assess the patients’ self-care behaviors for multiple problems in the study. The problems experienced by cancer patients and their self-care strategies may be greatly different. Meanwhile, changes often occur as the course of chemotherapy proceeds. The problems faced by the patients may not be the same ones after each cycle. Although an advantage of the nurse-led care program was that it delivered holistic assessments and individualized care, this also implied that different patients may use different strategies to cope with the same problem. Individualized interventions may lead to challenges in evaluating self-care behaviors. The impact of low intraclass correlation coefficient of behavior evaluation is not very clear at the moment. The data collection procedure was also feasible and acceptable. The only problem was the timing of the filling out of the baseline questionnaires. All 5 subjects filled out the baseline questionnaires at home after the day of the prechemotherapy medical consultation. This postponement in filling out the questionnaire might have an impact on baseline self-efficacy in the main study, because the brief instruction was regarded as a component of routine care, which will be served as the control in the main study. The subjects’ self-efficacy might change after the brief instruction. However, insisting that subjects fill out the questionnaires before the brief instruction may disturb the nurses’ work and violate patients’ will. One solution in the main study is to ask the subjects to fill out the self-efficacy questionnaire before the brief instruction and finish the other part at home if possible. The timing of the filling out of the baseline questionnaires will be recorded so that comparisons can be made in data analysis. Although no significant changes were found in the subjects’ QOL, self-efficacy, and symptom distress levels, a high level of satisfaction with the care that was delivered was reported in both the questionnaires and the interviews. The subjects thought that this service was helpful and worth popularizing. The whole program functioned in such a way as to serve as an important

Nurse-Led Care Program in a Chemotherapy Day Center

5 3 4 3 3 3

(100) (60) (80) (60) (60) (60)

Useless, n (%) V V V V 1 (20) V

resource of information. Patients usually begin chemotherapy with many questions due to inadequate communication with healthcare providers. However, the patients’ information needs are particularly high before going through a course of chemotherapy.10 Provision of enough information may reduce patients’ anxiety and depression and improve their self-efficacy and knowledge.45 The interviews supported this view. The subjects did feel relieved and less nervous after the prechemotherapy consultation. The telephone follow-ups also played an important role in the entire service package. Besides providing information continuously, the telephone follow-ups had the effect of encouraging the subjects to involve in coping with the impact of chemotherapy. Given the changes that may occur during chemotherapy, a nurse-led care program that covers the entire chemotherapy process may be necessary. Despite the encouraging results, there were several limitations to the pilot study. Although the study was developed based on the theory of transition, some essential components of the theory were not measured quantitatively in the pilot study because there were no suitable questionnaires on these components, such as awareness, preparation and knowledge, and meaning. These essential components will be explored in the main study using a qualitative approach. Also not examined in the pilot study was the likely magnitude of the service effect because of the 1-group pretestposttest design. In the main study, a single-center, open, randomized controlled trial will be conducted to examine the effect of this nurse-led care program. If the encouraging results of the pilot study can be confirmed in the main study, this nurse-led care program may prove to be an effective approach to improving outpatientbased chemotherapy care in Hong Kong. It would also shed light on the development of nurse-led care during chemotherapy in other areas.

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Conclusion

Facing service challenges caused by the increasing number of cancer patients receiving chemotherapy in outpatient settings, a nurse-led care program was proposed with the aim of improving the quality of care delivered to such patients. A pretest-posttest pilot study was conducted to assess the feasibility and acceptability of the nurse-led service. The implementation of the pilot study was completed smoothly. Encouraging feedback was obtained from the 5 subjects. This nurse-led care program was feasible and acceptable. A single-center, open, randomized controlled trial will be conducted to examine the effect of this nurse-led care service. Cancer NursingTM, Vol. 38, No. 5, 2015

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Development and Assessment of the Feasibility of a Nurse-Led Care Program for Cancer Patients in a Chemotherapy Day Center: Results of the Pilot Study.

The increasing number of cancer patients and inadequate communication in clinics are posing challenges to cancer patients receiving outpatient-based c...
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