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| ID | Type | Description | Link |
|---|---|---|---|
| DUMC-5477-03-12R0ER | |||
| DUMC-5477-04-12R1ER | |||
| CDR0000460231 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.
PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to cancer type (colorectal vs breast or prostate), sex, age (65-74 years vs 75 years and over), and race (white vs non-white). Patients are randomized to 1 of 2 intervention arms.
After completion of study intervention, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 640 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wait-list control | No Intervention | Wait-list control received diet & exercise counseling during year 2 as a courtesy | |
| Lifestyle counseling | Experimental | subjects randomized to receive diet & exercise counseling for one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral dietary and exercise intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year |
| Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion |
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DISEASE CHARACTERISTICS:
Diagnosed colorectal, prostate, or female breast cancer
Body mass index ≥ 25 kg/m^2 and < 40 kg/m^2
Currently exercising < 150 minutes/week
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Menopausal status not specified
No serious intercurrent medical condition or disability that could preclude study treatment, including any of the following:
Ability to read, write, and speak English
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Demark-Wahnefried, PhD | Duke Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Durham | Durham | North Carolina | 27705 | United States | ||
| Duke Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22614994 | Result | Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Miller PE, Hartman TJ, Cohen HJ. Reach out to enhance wellness home-based diet-exercise intervention promotes reproducible and sustainable long-term improvements in health behaviors, body weight, and physical functioning in older, overweight/obese cancer survivors. J Clin Oncol. 2012 Jul 1;30(19):2354-61. doi: 10.1200/JCO.2011.40.0895. Epub 2012 May 21. | |
| 22709810 |
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one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. |
| one year |
| Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year |
| Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year |
| Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year |
| Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year |
| Stage of readiness for exercise and dietary change as assessed by the stage of change algorithms at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Result |
| Miller PE, Morey MC, Hartman TJ, Snyder DC, Sloane R, Cohen HJ, Demark-Wahnefried W. Dietary patterns differ between urban and rural older, long-term survivors of breast, prostate, and colorectal cancer and are associated with body mass index. J Acad Nutr Diet. 2012 Jun;112(6):824-31, 831.e1. doi: 10.1016/j.jand.2012.02.021. |
| 19637244 | Result | Mosher CE, Sloane R, Morey MC, Snyder DC, Cohen HJ, Miller PE, Demark-Wahnefried W. Associations between lifestyle factors and quality of life among older long-term breast, prostate, and colorectal cancer survivors. Cancer. 2009 Sep 1;115(17):4001-9. doi: 10.1002/cncr.24436. |
| 19436015 | Result | 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. |
| 19117329 | Result | Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39. doi: 10.1002/pon.1491. |
| 26512712 | Result | Morey MC, Blair CK, Sloane R, Cohen HJ, Snyder DC, Demark-Wahnefried W. Group trajectory analysis helps to identify older cancer survivors who benefit from distance-based lifestyle interventions. Cancer. 2015 Dec 15;121(24):4433-40. doi: 10.1002/cncr.29684. Epub 2015 Oct 29. |
| 24648018 | Result | Winger JG, Mosher CE, Rand KL, Morey MC, Snyder DC, Demark-Wahnefried W. Diet and exercise intervention adherence and health-related outcomes among older long-term breast, prostate, and colorectal cancer survivors. Ann Behav Med. 2014 Oct;48(2):235-45. doi: 10.1007/s12160-014-9598-7. |
| 24389524 | Result | Blair CK, Morey MC, Desmond RA, Cohen HJ, Sloane R, Snyder DC, Demark-Wahnefried W. Light-intensity activity attenuates functional decline in older cancer survivors. Med Sci Sports Exerc. 2014 Jul;46(7):1375-83. doi: 10.1249/MSS.0000000000000241. |
| 20122025 | Result | Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Cohen HJ. Promoting healthy lifestyles in older cancer survivors to improve health and preserve function. J Am Geriatr Soc. 2009 Nov;57 Suppl 2(Suppl 2):S262-4. doi: 10.1111/j.1532-5415.2009.02507.x. |
| 18792788 | Result | Miller P, Demark-Wahnefried W, Snyder DC, Sloane R, Morey MC, Cohen H, Kranz S, Mitchell DC, Hartman TJ. Dietary supplement use among elderly, long-term cancer survivors. J Cancer Surviv. 2008 Sep;2(3):138-48. doi: 10.1007/s11764-008-0060-3. Epub 2008 Jul 11. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D011471 | Prostatic Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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