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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
| Korea University Anam Hospital | OTHER |
| Asan Medical Center |
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The Objectives of this study is
***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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YoungSung Lee, Ph.D | Contact | +82-31-920-2010 | lee.medric@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| YoungSung Lee, MD, Ph.D | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Boondang Hospital | Recruiting | Boondang | Gyunggi | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
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| OTHER |
| Ajou University School of Medicine | OTHER |
| Kyunghee University Medical Center | OTHER |
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|
| 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. |
|
| 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 |
| the Hospital Anxiety and Depression scale(HADS) | baseline, after 3month, 6month, and 12month |
| Cancer Belief System(CBS) | baseline, after 3month, 6month, and 12month |
| National Cancer Center | Recruiting | Goyang | Gyunggi | South Korea |
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| Ajou University Medical Center | Recruiting | Suwon | Gyunggi | South Korea |
|
| Keimyng University Dongsan Center | Recruiting | Daegu | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Ewha Womans University Mokdong Hospital | Recruiting | Seoul | South Korea |
|
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
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| KyungHee University Medical Center | Recruiting | Seoul | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| 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. |
| 21190455 | 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. |
| 19436015 | 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. |
| 22263004 | Background | Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4. |
| 21356647 | 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. |
| 28464804 | Derived | 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D013274 | Stomach Neoplasms |
| D008175 | Lung Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
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