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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303875 |
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.
Condition | Intervention | Phase |
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Breast Cancer Colorectal Cancer Prostate Cancer |
Behavioral: behavioral dietary intervention Behavioral: exercise intervention Other: preventative dietary intervention |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized |
Official Title: | RENEW: Reach Out to Enhance Wellness in Older Survivors |
Estimated Enrollment: | 640 |
Study Start Date: | December 2003 |
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.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosed colorectal, prostate, or female breast cancer
PATIENT CHARACTERISTICS:
No serious intercurrent medical condition or disability that could preclude study treatment, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
Veterans Affairs Medical Center - Durham | |
Durham, North Carolina, United States, 27705 |
Study Chair: | Wendy Demark-Wahnefried, PhD | Duke University |
Study ID Numbers: | CDR0000460231, DUMC-5477-03-12R0ER, DUMC-5477-04-12R1ER |
Study First Received: | March 15, 2006 |
Last Updated: | May 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00303875 History of Changes |
Health Authority: | United States: Federal Government |
recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
stage IV breast cancer recurrent colon cancer stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer recurrent rectal cancer stage I rectal cancer stage II rectal cancer stage III rectal cancer stage IV rectal cancer |
Digestive System Neoplasms Prostatic Diseases Genital Neoplasms, Male Skin Diseases Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Quality of Life Breast Neoplasms Urogenital Neoplasms Overweight |
Genital Diseases, Male Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms Rectal Cancer Digestive System Diseases Gastrointestinal Neoplasms Prostatic Neoplasms Colorectal Neoplasms Breast Diseases |
Digestive System Neoplasms Prostatic Diseases Genital Neoplasms, Male Skin Diseases Gastrointestinal Diseases Colonic Diseases Breast Neoplasms Urogenital Neoplasms Genital Diseases, Male Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Neoplasms Prostatic Neoplasms Colorectal Neoplasms Breast Diseases |