Status:
ACTIVE_NOT_RECRUITING
Lifestyle, Exercise, and Nutrition Study Early After Diagnosis
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and...
Detailed Description
Currently the Department of Health and Human Services, the American Cancer Society and others provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do not follow the...
Eligibility Criteria
Inclusion
- Diagnosed with Stage I-III breast cancer
- Scheduled to receive neoadjuvant or adjuvant chemotherapy
- Physically able to walk
- Able to complete forms, understand instructions and read intervention book in English
- Agrees to be randomly assigned to either intervention or usual care group
Exclusion
- Women who have completed their 2nd chemotherapy
- Women already practicing dietary or physical activity guidelines
- Are pregnant or intending to become pregnant in the next year
- Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \< 40%
- Presence of dementia or major psychiatric disease
- Non-English speaking
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2026
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT03314688
Start Date
January 2 2018
End Date
July 31 2026
Last Update
February 3 2025
Active Locations (2)
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1
Yale University
New Haven, Connecticut, United States, 06510
2
Dana Farber Cancer Center
Boston, Massachusetts, United States, 02215