The Efficacy of Health Partnership Program for Cancer Patients
Conditions
Breast Cancer - Colon Cancer - Gastric Cancer - Lung Cancer
Conditions: Keywords
Exercise, Diet, Posttraumatic growth
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Tailored health partnership program Type: Behavioral
Name: Usual care and health education workshop Type: Behavioral
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: 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
Locations
Seoul National University Boondang Hospital
Boondang, Gyunggi, Korea, Republic of
Status: Recruiting
Contact: Jae Young Lim, PhD
National Cancer Center
Goyang, Gyunggi, Korea, Republic of
Status: Recruiting
Contact: Youngsung Lee, PhD - lee.medric@gmail.com
Ajou University Medical Center
Suwon, Gyunggi, Korea, Republic of
Status: Recruiting
Contact: Mi Sun Chun, PhD
Keimyng University Dongsan Center
Daegu, Korea, Republic of
Status: Recruiting
Contact: Chiheum Cho, PhD
Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: KyungHae Jung, PhD
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Soon Nam Lee, PhD
Korea University Anam Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Eun Sook Lee, PhD
KyungHee University Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Siyoung Kim, PhD
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Sung Kim, PhD
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Young Ho Yun, PhD - lawyun08@gmail.com
Start Date
February 2012
Completion Date
June 2013
Sponsors
National Cancer Center, Korea
Source
National Cancer Center, Korea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page