The Efficacy of Health Partnership Program for Cancer Patients

Breast Cancer Clinical Trial

Official title:

The Efficacy of Health Partnership Program for Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01527409
• Other study ID #: NCCCTS-11-598
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2012
• Last updated: February 6, 2012
• Start date: February 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2012
• Source: National Cancer Center, Korea
• Contact: YoungSung Lee, Ph.D
• Phone: +82-31-920-2010
• Email: lee.medric[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Gastric Cancer
• Lung Cancer

Intervention

Behavioral:
• Tailored health partnership program
When intervention group participate in the tailored program, they can receive various information which is related with three strategic areas (exercise, diet, and posttraumatic growth). Three areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model. Patients will be received tailored manual and workbook for health tele-coaching that help them to lead their healthy life. The health tele-coaching will be operated sixteen times for 24 weeks. Intervention group will be provided three contents (exercise, diet, and posttraumatic growth) from health partners. The health partners took a certificate that is related with health, leadership and coaching. Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life. It will be proceeded for four hours. Three hours is for the leadership, and the last one hour is for presentation of their health mission statement.
• Usual care and health education workshop
While intervention group participate in the tailored health partnership program, control group can receive various information which is related with ten contents for health management (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation). They will be provided a workshop and booklet for a health education for four hours. Twelve month later, they will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth as same as the intervention group.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Boondang Hospital	Boondang	Gyunggi
Korea, Republic of	Keimyng University Dongsan Center	Daegu
Korea, Republic of	National Cancer Center	Goyang	Gyunggi
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	Ajou University Medical Center	Suwon	Gyunggi

Sponsors (7)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Ajou University School of Medicine, Asan Medical Center, Korea University Anam Hospital, Kyunghee University Medical Center, Samsung Medical Center, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

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. — View 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) ).

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. — View 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. — View Citation

Kravitz, R. L., D. J. Tancredi, et al. (2009).

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. — View Citation

Park, S. M., M. K. Lim, et al. (2007).

Shin, H. W., D. Y. Noh, et al. (2009).

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).

Street, R. L., Jr., C. Slee, et al.

Vale, M. J., M. V. Jelinek, et al. (2003).

Wolever RQ, Dreusicke M, Fikkan J, Hawkins TV, Yeung S, Wakefield J, Duda L, Flowers P, Cook C, Skinner E. Integrative health coaching for patients with type 2 diabetes: a randomized clinical trial. Diabetes Educ. 2010 Jul-Aug;36(4):629-39. doi: 10.1177/0145721710371523. Epub 2010 Jun 9. — View Citation

Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI)	How much the patient does exercise will be measured using "MET" score. Change in diet will be observed by analyzing 3day recall.	baseline, 3month, 6month, and 12month	No
Secondary	Seven habit profile		baseline, 3month, 6month, and 12month	No
Secondary	the European Organisation for the Research and Treatment of Cancer Quality-of-life Questionnaire-Core 30(EORTC QLQ C-30)		baseline, after 3month, 6month, and 12month	No
Secondary	Ed Diner's Satisfaction with Life Scale		baseline, after 3month, 6month, and 12month	No
Secondary	Impact of Event Scale-Revised		baseline, after 3month, 6month, and 12month	No
Secondary	Social Support(MOS-SSS)		baseline, after 3month, 6month, and 12month	No
Secondary	the Hospital Anxiety and Depression scale(HADS)		baseline, after 3month, 6month, and 12month	No
Secondary	Cancer Belief System(CBS)		baseline, after 3month, 6month, and 12month	No