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Spots Global Cancer Trial Database for The Efficacy of Health Partnership Program for Cancer Patients

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Trial Identification

Brief Title: The Efficacy of Health Partnership Program for Cancer Patients

Official Title: The Efficacy of Health Partnership Program for Cancer Patients

Study ID: NCT01527409

Study Description

Brief Summary: 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

Detailed Description: \*\*\*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.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Seoul National University Boondang Hospital, Boondang, Gyunggi, Korea, Republic of

National Cancer Center, Goyang, Gyunggi, Korea, Republic of

Ajou University Medical Center, Suwon, Gyunggi, Korea, Republic of

Keimyng University Dongsan Center, Daegu, , Korea, Republic of

Asan Medical Center, Seoul, , Korea, Republic of

Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of

Korea University Anam Hospital, Seoul, , Korea, Republic of

KyungHee University Medical Center, Seoul, , Korea, Republic of

Samsung Medical Center, Seoul, , Korea, Republic of

Seoul National University Hospital, Seoul, , Korea, Republic of

Contact Details

Name: YoungSung Lee, MD, Ph.D

Affiliation: National Cancer Center, Korea

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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