The Efficacy of Health Partnership Program for Cancer Patients

NCT01527409 | Unknown

• 1 other identifier: NCCCTS-11-598
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 10

Brief Summary

The Objectives of this study is

1. 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. 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. 3.To assess the efficacy of such intervention compared with usual care in cancer patients

Conditions

Breast Cancer; Colon Cancer; Gastric Cancer; Lung Cancer

Keywords

Exercise; Diet; Posttraumatic growth

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Seven habit profile

  baseline, 3month, 6month, and 12month

• 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

• Ed Diner's Satisfaction with Life Scale

  baseline, after 3month, 6month, and 12month

• Impact of Event Scale-Revised

  baseline, after 3month, 6month, and 12month

• Social Support(MOS-SSS)

  baseline, after 3month, 6month, and 12month

Study Arms (2)

Experimetal Arm

EXPERIMENTAL

Providing tailored health care program, which provides various information related to exercise, diet, and posttraumatic growth. Tailored health partnership program consists of three strategic areas (exercise, diet, and posttraumatic growth). Those areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model. Patients who participate in the tailored health partnership program will be received tailored manual and workbook for tele-coaching that help them to lead their healthy life. Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life.

Behavioral: Tailored health partnership program

Control Arm

NO INTERVENTION

Providing usual care. Also, patients will be provided a workshop for health education that is dealt with ten areas (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation). Twelve month later, patients will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth.

Behavioral: Usual care and health education workshop

Interventions

Tailored health partnership program BEHAVIORAL

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.

Experimetal Arm

Usual care and health education workshop BEHAVIORAL

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.

Control Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Samsung Medical Center: collaborator
• Seoul National University Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Asan Medical Center: collaborator
• Ajou University School of Medicine: collaborator
• Kyunghee University Medical Center: collaborator

Study Sites (10)

Seoul National University Boondang Hospital

Boondang, Gyunggi, South Korea

RECRUITING

National Cancer Center

Goyang, Gyunggi, South Korea

RECRUITING

Ajou University Medical Center

Suwon, Gyunggi, South Korea

RECRUITING

Keimyng University Dongsan Center

Daegu, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

KyungHee University Medical Center

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (14)

• 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) ).

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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).

  BACKGROUND

• Street, R. L., Jr., C. Slee, et al.

  BACKGROUND

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

  BACKGROUND

• Wolever, R. Q., M. Dreusicke, et al.

  BACKGROUND

• 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.

  PMID: 17602076 BACKGROUND

• 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.

  PMID: 21190455 BACKGROUND

• 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.

  PMID: 19436015 BACKGROUND

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

  PMID: 22263004 BACKGROUND

• 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.

  PMID: 21356647 BACKGROUND

• 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.

  PMID: 28464804 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Stomach Neoplasms; Lung Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• YoungSung Lee, MD, Ph.D

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YoungSung Lee, Ph.D

CONTACT

+82-31-920-2010; lee.medric@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Cancer Management Branch

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: February 7, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: February 7, 2012

Record last verified: 2012-02

Locations

KR (10)