The Efficacy of Health Partnership Program for Cancer Patients

Study Overview
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Brief Summary
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The Objectives of this study is To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of participating in tailored program (Health Partnership Program) for 24 weeks To evaluate the efficacy for quality of life, life satisfaction, health leadership, anxiety, depression, impact of event, social support, cancer belief as a result of participating in tailored program (Health Partnership Program) for 24 weeks To assess the efficacy of such intervention compared with usual care in cancer patients

Detailed Description
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***Background Improving cancer patients' quality of life has been increasing subject of research for several years. Especially, the patients and their families who are needed to deal with specific care on diverse aspects, such as social, spiritual, existential, psychological aspect should be provided integrated program. Multidimensional characteristics of the health partnership program were addressed in National Cancer Center (NCC) for exercise, diet, and posttraumatic growth based on transtheoretical (TTM) model, social cognitive theory, health behavioral model, and coaching strategies. This program points out the importance of behavioral approaches in managing their healthy life according to improve patterns of three areas (exercise, diet, and posttraumatic growth). Strategies that investigators mentioned above can lead those three areas to be effective. To objective of this study is to support cancer patients to cope with exercise, diet, and posttraumatic growth through tailored program (the health partnership program), and then evaluate the efficacy of the health partnership program. From evidence extracted from a literature review, contents of the program was elaborated, and tailored from the TTM model. The curriculum is currently being reviewed and validated by expert group of oncologists, nurse, psychologist and health education scientists. ***Method To determine the efficacy of the program (the health partnership program), a randomized controlled trial will be conducted: After excluding patients with other causes (anemia, thyroid disease, co morbidities etc), 248 patients will be recruited based on statistical assumption of alpha (0.05), beta (0.20=power 80%), and dropout rate (15%). First, patients will be stratified according to their age, sex (male vs. female), cancer types (stomach cancer, Breast cancer, cervical cancer, colorectal (except rectal cancer) cancer, and lung cancer), and then allocated to an intervention or control group. When intervention group participates in the tailored program (the health partnership program), they can receive various information which is related to health management and improving quality of life. The health partnership program consists of 16 time's tele-coaching, a self leadership workshop, and providing health materials (manuals, workbook, and booklet). Especially, those will be dealt with managing three areas; exercise, diet, and posttraumatic growth based on the transtheoretical model (TTM), social cognitive theory, health behavioral model, and coaching strategies. Cancer patients who are participated in the tailored program will be received tailored feedbacks that enhance participants of the next level of the program. On the other hand, the control group could not participate in the health partnership program. The control group could only be treated by usual care and a health education workshop with a health booklet. However, the control group can participate in the health partnership program after 12 month. Data will be collected before randomization, after intervention, and after a follow-up of 3, 6, and 12 months.

Official Title
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The Efficacy of Health Partnership Program for Cancer Patients

Conditions
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Breast Cancer, Colon Cancer, Gastric Cancer, Lung Cancer

Intervention / Treatment
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* Behavioral: Tailored health partnership program
* Behavioral: Usual care and health education workshop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult(≥ 20 years) Within 24 months of completion of primary treatment with curative intent (Surgery, radiotherapy, chemotherapy) Breast, cervical, colorectal (except rectal cancer), lung, and stomach cancer More than two problematic areas among exercise, diet (Fruit & Vegetable: F&V), and posttraumatic growth(exercise < 150min/week, ≥ 3mets, F&V < 5/day, PTGI < 71) Exclusion Criteria: Evidence of secondary tumor, metastasis and recurrence Patients undergoing or planning surgery, radiation therapy or chemotherapy Not Korean speaking and reading (Not communication with Korean) Not understanding of the study purpose and not written informed consent Participants who have an similar study experience Major health problem in which exercise/nutrition intervention is contraindicated at the discretion of clinician; cardiovascular disease (congestive heart failure, angina), pulmonary disease (chronic obstructive pulmonary disease, restrictive pulmonary disease), uncontrolled hypertension, poorly controlled diabetes and severe musculoskeletal disease and so on Sign of infection (body temperature ≥ 37.2℃ or WBC ≥ 11,000) Being pregnant Thrombocytopenia (platelet count ≤ 100,000/mcl) Anemia (Hb ≤ 10g/dL) SGOT or SGPT > 40 IU/L Creatinine > 1.2 mg/dL Severe psychiatric disorder (psychotic disorder, major depression and so on) or suicidal tendencies dyspnea

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimetal Arm<br>Providing tailored health care program, which provides various information related to exercise, diet, and posttraumatic growth. Tailored health partnership program consists of three strategic areas (exercise, diet, and posttraumatic growth). Those areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model. Patients who participate in the tailored health partnership program will be received tailored manual and workbook for tele-coaching that help them to lead their healthy life. Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life. | Behavioral: Tailored health partnership program<br>* When intervention group participate in the tailored program, they can receive various information which is related with three strategic areas (exercise, diet, and posttraumatic growth). Three areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model. Patients will be received tailored manual and workbook for health tele-coaching that help them to lead their healthy life. The health tele-coaching will be operated sixteen times for 24 weeks. Intervention group will be provided three contents (exercise, diet, and posttraumatic growth) from health partners. The health partners took a certificate that is related with health, leadership and coaching. Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life. It will be proceeded for four hours. Three hours is for the leadership, and the last one hour is for presentation of their health mission statement.<br>|
| No Intervention: Control Arm<br>Providing usual care. Also, patients will be provided a workshop for health education that is dealt with ten areas (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation). Twelve month later, patients will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth. | Behavioral: Usual care and health education workshop<br>* While intervention group participate in the tailored health partnership program, control group can receive various information which is related with ten contents for health management (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation). They will be provided a workshop and booklet for a health education for four hours. Twelve month later, they will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth as same as the intervention group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI) | How much the patient does exercise will be measured using MET score. Change in diet will be observed by analyzing 3day recall. | baseline, 3month, 6month, and 12month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seven habit profile |  | baseline, 3month, 6month, and 12month | 
| the European Organisation for the Research and Treatment of Cancer Quality-of-life Questionnaire-Core 30(EORTC QLQ C-30) |  | baseline, after 3month, 6month, and 12month | 
| Ed Diner's Satisfaction with Life Scale |  | baseline, after 3month, 6month, and 12month | 
| Impact of Event Scale-Revised |  | baseline, after 3month, 6month, and 12month | 
| Social Support(MOS-SSS) |  | baseline, after 3month, 6month, and 12month | 
| the Hospital Anxiety and Depression scale(HADS) |  | baseline, after 3month, 6month, and 12month | 
| Cancer Belief System(CBS) |  | baseline, after 3month, 6month, and 12month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Diet, Posttraumatic growth