TOPS for African American Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Obesity; Weight Loss; Feasibility and Acceptability of the TOPS Program; Breast Cancer
• Interventions: Behavioral: TOPS

• Registration Number: NCT04741802
• Lead Sponsor: Duke University

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Study Start: 2021-06-11
• Primary Completion: 2022-03-16
• Study Completion: 2022-08-30
• Results First Submitted: 2023-01-24
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Results First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOPS	TOPS	weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors

Primary Outcome Measures

Name	Time	Method
Number of Women Who Attended the Information Session and Joined the TOPS Program	One-time information session
Number of Women Who Remained in the Program for 24 Weeks	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	One-time invitation
Number of Women Who Remained in the Program for 12 Weeks	up to 12 weeks	Measured by the number of women who reported to the 12-week weigh in.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Participants' Weight as Measured by Scale Reading	baseline, 3 months, 6 months, 12 months

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States