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Clinical Trials/NCT04741802
NCT04741802
Completed
Not Applicable

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

Duke University1 site in 1 country26 target enrollmentJune 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Feasibility and Acceptability of the TOPS Program
Sponsor
Duke University
Enrollment
26
Locations
1
Primary Endpoint
Number of Women Who Attended the Information Session and Joined the TOPS Program
Status
Completed
Last Updated
2 years ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
June 11, 2021
End Date
August 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Number of Women Who Attended the Information Session and Joined the TOPS Program

Time Frame: One-time information session

Number of Women Who Remained in the Program for 24 Weeks

Time Frame: up to 24 weeks

Measured by the number of women who reported to the 24-week weigh in.

Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session

Time Frame: One-time invitation

Number of Women Who Remained in the Program for 12 Weeks

Time Frame: up to 12 weeks

Measured by the number of women who reported to the 12-week weigh in.

Secondary Outcomes

  • Percent Change in Participants' Weight as Measured by Scale Reading(baseline, 3 months, 6 months, 12 months)

Study Sites (1)

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