The Objectives of this study is 1. To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of participating in tailored program (Health Partnership Program) for 24 weeks 2. 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 3. To assess the efficacy of such intervention compared with usual care in cancer patients
\*\*\*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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
248
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.
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.
Seoul National University Boondang Hospital
Boondang, Gyunggi, South Korea
RECRUITINGNational Cancer Center
Goyang, Gyunggi, South Korea
RECRUITINGAjou University Medical Center
Suwon, Gyunggi, South Korea
RECRUITINGKeimyng University Dongsan Center
Daegu, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGEwha Womans University Mokdong Hospital
Seoul, South Korea
RECRUITINGKorea University Anam Hospital
Seoul, South Korea
RECRUITINGKyungHee University Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGChanges 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.
Time frame: baseline, 3month, 6month, and 12month
Seven habit profile
Time frame: 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)
Time frame: baseline, after 3month, 6month, and 12month
Ed Diner's Satisfaction with Life Scale
Time frame: baseline, after 3month, 6month, and 12month
Impact of Event Scale-Revised
Time frame: baseline, after 3month, 6month, and 12month
Social Support(MOS-SSS)
Time frame: baseline, after 3month, 6month, and 12month
the Hospital Anxiety and Depression scale(HADS)
Time frame: baseline, after 3month, 6month, and 12month
Cancer Belief System(CBS)
Time frame: baseline, after 3month, 6month, and 12month
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