Breast Cancer Clinical Trial
Official title:
The Efficacy of Health Partnership Program for Cancer Patients
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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