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| ID | Type | Description | Link |
|---|---|---|---|
| DUMC-1547-02-8R4ER | |||
| DUMC-1547-00-8R2ER | |||
| NCI-H02-0088 | |||
| CDR0000069355 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve physical function and quality of life in patients who have early-stage breast cancer or prostate cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and exercise-based counseling program with that of a standard home-based counseling program in promoting health in patients who have early-stage breast cancer or prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
In both arms, counseling continues every 2 weeks for 6 months.
Patients are followed at 6 months.
PROJECTED ACCRUAL: A total of 420 patients (210 per arm) will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fatigue assessment and management | Procedure | |||
| nutritional support | Procedure | |||
| physical therapy | Procedure | |||
| psychosocial assessment and care | Procedure | |||
| quality-of-life assessment | Procedure |
DISEASE CHARACTERISTICS:
Diagnosis of early-stage breast or prostate cancer within the past 18 months
Dietary and physical activity habits and baseline functional status that places patient at risk
Potentially able to increase physical activity and to follow a low-fat, plant-based diet
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Demark-Wahnefried, PhD | Duke Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12689742 | Result | Demark-Wahnefried W, Morey MC, Clipp EC, Pieper CF, Snyder DC, Sloane R, Cohen HJ. Leading the Way in Exercise and Diet (Project LEAD): intervening to improve function among older breast and prostate cancer survivors. Control Clin Trials. 2003 Apr;24(2):206-23. doi: 10.1016/s0197-2456(02)00266-0. | |
| 15516261 | Result |
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| Demark-Wahnefried W, Clipp EC, Morey MC, Pieper CF, Sloane R, Snyder DC, Cohen HJ. Physical function and associations with diet and exercise: Results of a cross-sectional survey among elders with breast or prostate cancer. Int J Behav Nutr Phys Act. 2004 Oct 29;1(1):16. doi: 10.1186/1479-5868-1-16. |
| 16849763 | Result | Demark-Wahnefried W, Clipp EC, Morey MC, Pieper CF, Sloane R, Snyder DC, Cohen HJ. Lifestyle intervention development study to improve physical function in older adults with cancer: outcomes from Project LEAD. J Clin Oncol. 2006 Jul 20;24(21):3465-73. doi: 10.1200/JCO.2006.05.7224. |
| 17182834 | Result | Stull VB, Snyder DC, Demark-Wahnefried W. Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. J Nutr. 2007 Jan;137(1 Suppl):243S-248S. doi: 10.1093/jn/137.1.243S. |
| 17761229 | Result | Clutter Snyder D, Sloane R, Haines PS, Miller P, Clipp EC, Morey MC, Pieper C, Cohen H, Demark-Wahnefried W. The Diet Quality Index-Revised: a tool to promote and evaluate dietary change among older cancer survivors enrolled in a home-based intervention trial. J Am Diet Assoc. 2007 Sep;107(9):1519-29. doi: 10.1016/j.jada.2007.06.014. |
| 18800990 | Result | Morey MC, Sloane R, Pieper CF, Peterson MJ, Pearson MP, Ekelund CC, Crowley GM, Demark-Wahnefried W, Snyder DC, Clipp EC, Cohen HJ. Effect of physical activity guidelines on physical function in older adults. J Am Geriatr Soc. 2008 Oct;56(10):1873-8. doi: 10.1111/j.1532-5415.2008.01937.x. Epub 2008 Sep 17. |
| 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. |
| 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D005221 | Fatigue |
| D044342 | Malnutrition |
| D011471 | Prostatic Neoplasms |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic 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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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D026741 | Physical Therapy Modalities |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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