Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
NCT ID: NCT00037024
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2002-04-30
2004-10-31
Brief Summary
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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.
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Detailed Description
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* Compare the efficacy of a diet and exercise-based home-based counseling program versus a standard home-based counseling program for improving physical function at 6 and 12 months for patients with early-stage breast or prostate cancer.
* Compare the effects of these home-based programs on diet quality, physical activity, weight status, depression, and quality of life of these patients.
* Compare the factors, such as gender, race, and social support, that interact with these home-based programs to predict program efficacy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
* Arm I: Patients receive home-based telephone counseling by a personal nutritionist and a personal trainer.
* Arm II: Patients receive home-based standard health telephone counseling in unrelated areas of cancer care (e.g., sun exposure, screening, and falls prevention).
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.
Conditions
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Study Design
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OTHER
Interventions
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fatigue assessment and management
nutritional support
physical therapy
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 65 and over
Sex:
* Male or female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Able to speak and write English
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No other illness or condition that would preclude adherence to a plant-based diet or exercise
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
65 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Wendy Demark-Wahnefried, PhD
Role: STUDY_CHAIR
Duke Cancer Institute
Locations
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Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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DUMC-1547-02-8R4ER
Identifier Type: -
Identifier Source: secondary_id
DUMC-1547-00-8R2ER
Identifier Type: -
Identifier Source: secondary_id
NCI-H02-0088
Identifier Type: -
Identifier Source: secondary_id
CDR0000069355
Identifier Type: -
Identifier Source: secondary_id
Pro00009493
Identifier Type: -
Identifier Source: org_study_id
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