Breast Cancer Clinical Trial

TOPS for African American Breast Cancer Survivors

Summary

For women diagnosed with breast cancer, dietary, weight loss, and physical activity have been linked with clinically significant weight loss; decreased risk of death; reduced risk of breast cancer recurrence; fewer cardiovascular events; and improved physical function. The objectives of these aims are to a) determine if the TOPS materials and format are possible and accepted by overweight and obese African American breast cancer survivors; b) gather data for sample size calculations for a larger future study.

To meet these aims, we will collect data to see if participants enjoyed the TOPS program and suggestions for changes to the program to make it fit their needs. Other methods will measure recruitment, retention, and weight change.

Aim 1: Examine the feasibility and acceptability of a national, low-cost, community-based, peer-led, weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC).

Aim 2: Assess the weight change of overweight and obese African American breast cancer survivors after 6 months in the TOPS program to gather data for sample size calculations for a future RCT.

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Eligibility Criteria

Inclusion Criteria:

Women diagnosed with breast cancer with BMI ≥ 25 kg/m after completion of primary 2 therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).

Exclusion Criteria:

Women whose oncology providers do not agree with their participation in a weight loss program or those participating in another weight loss program.

Study is for people with:

Breast Cancer

Estimated Enrollment:

26

Study ID:

NCT04741802

Recruitment Status:

Completed

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Health System
Durham North Carolina, 27710, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

26

Study ID:

NCT04741802

Recruitment Status:

Completed

Sponsor:


Duke University

How clear is this clinincal trial information?

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