The Efficacy of Health Partnership Program for Cancer Patients
20 Years
N/A
Both
Breast Cancer, Colon Cancer, Gastric Cancer, Lung Cancer
Trial Information
The Efficacy of Health Partnership Program for 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI)
Outcome Description:
How much the patient does exercise will be measured using "MET" score. Change in diet will be observed by analyzing 3day recall.
Outcome Time Frame:
baseline, 3month, 6month, and 12month
Safety Issue:
No
Principal Investigator
YoungSung Lee, MD, Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Center, Korea
Authority:
Korea: Food and Drug Administration
Study ID:
NCCCTS-11-598
NCT ID:
NCT01527409
Start Date:
February 2012
Completion Date:
June 2013
Related Keywords:
- Breast Cancer
- Colon Cancer
- Gastric Cancer
- Lung Cancer
- Exercise
- Diet
- Posttraumatic growth
- Breast Neoplasms
- Colonic Neoplasms
- Lung Neoplasms
- Stomach Neoplasms
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