Clinical Trials Directory

Trials / Completed

CompletedNCT04741802

TOPS for African American Breast Cancer Survivors

Feasibility and Acceptability of a Community-based Weight Loss Program Among African American Breast Cancer Survivors

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Duke University · Academic / Other
Sex
Female
Age
55 Years
Healthy volunteers
Not accepted

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 (randomized controlled trial).

Conditions

Interventions

TypeNameDescription
BEHAVIORALTOPSweight 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).

Timeline

Start date
2021-06-11
Primary completion
2022-03-16
Completion
2022-08-30
First posted
2021-02-05
Last updated
2024-02-28
Results posted
2024-02-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04741802. Inclusion in this directory is not an endorsement.