Clinical trial NCT01527409: The Efficacy of Health Partnership Program for Cancer Patients
Official title: The Efficacy of Health Partnership Program for Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Colon Cancer
Gastric Cancer
Lung Cancer
Keywords: Exercise
Diet
Posttraumatic growth
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Samsung Medical Center
name: Seoul National University Hospital
name: Korea University Anam Hospital
name: Asan Medical Center
name: Ajou University School of Medicine
name: Kyunghee University Medical Center
First posted: 2012-02-07
Enrollment: 248
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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

Primary outcomes:
measure: Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI)
timeFrame: baseline, 3month, 6month, and 12month
Secondary outcomes:
measure: Seven habit profile
timeFrame: baseline, 3month, 6month, and 12month
measure: the European Organisation for the Research and Treatment of Cancer Quality-of-life Questionnaire-Core 30(EORTC QLQ C-30)
timeFrame: baseline, after 3month, 6month, and 12month
measure: Ed Diner's Satisfaction with Life Scale
timeFrame: baseline, after 3month, 6month, and 12month
measure: Impact of Event Scale-Revised
timeFrame: baseline, after 3month, 6month, and 12month
measure: Social Support(MOS-SSS)
timeFrame: baseline, after 3month, 6month, and 12month
measure: the Hospital Anxiety and Depression scale(HADS)
timeFrame: baseline, after 3month, 6month, and 12month
measure: Cancer Belief System(CBS)
timeFrame: baseline, after 3month, 6month, and 12month
Other outcomes:
Locations:
city: Boondang
country: Korea, Republic of
facility: Seoul National University Boondang Hospital
state: Gyunggi
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyunggi
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
state: Gyunggi
city: Daegu
country: Korea, Republic of
facility: Keimyng University Dongsan Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: National Cancer Center, Korea
name: YoungSung Lee, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eun Sook Lee, M. K. L., Soo Hyun Kim, Jung Sil Ro, Han Sung Kang, Seok Won Kim, Keun Seok Lee, Young Ho Yun. (2010(Accepted) ).
citation: Kravitz, R. L., D. J. Tancredi, et al. (2009).
citation: Park, S. M., M. K. Lim, et al. (2007).
citation: Shin, H. W., D. Y. Noh, et al. (2009).
citation: Soo Hyun Kim, M. S. S., Han Sul Lee, Eun Sook Lee, Jung Sil Ro, Han Sung Kang, Seok Won Kim, Won Hee Lee, Chun Ja Kim, Hee Soon Kim, Joo hyung Kim, Young Ho Yun (2010).
citation: Street, R. L., Jr., C. Slee, et al.
citation: Vale, M. J., M. V. Jelinek, et al. (2003).
citation: Wolever, R. Q., M. Dreusicke, et al.
citation: Demark-Wahnefried W, Clipp EC, Lipkus IM, Lobach D, Snyder DC, Sloane R, Peterson B, Macri JM, Rock CL, McBride CM, Kraus WE. Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors. J Clin Oncol. 2007 Jul 1;25(19):2709-18. doi: 10.1200/JCO.2007.10.7094.
citation: Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
citation: Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
citation: Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.
citation: Kim SH, Shin MS, Lee HS, Lee ES, Ro JS, Kang HS, Kim SW, Lee WH, Kim HS, Kim CJ, Kim J, Yun YH. Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. Oncol Nurs Forum. 2011 Mar;38(2):E97-106. doi: 10.1188/11.ONF.E97-E106.
citation: Yun YH, Kim YA, Lee MK, Sim JA, Nam BH, Kim S, Lee ES, Noh DY, Lim JY, Kim S, Kim SY, Cho CH, Jung KH, Chun M, Lee SN, Park KH, Park S. A randomized controlled trial of physical activity, dietary habit, and distress management with the Leadership and Coaching for Health (LEACH) program for disease-free cancer survivors. BMC Cancer. 2017 May 2;17(1):298. doi: 10.1186/s12885-017-3290-9.