TOPS for African American Breast Cancer Survivors

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

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Breast Cancer; Weight Loss; Feasibility and Acceptability of the TOPS Program
• Intervention / Treatment: Behavioral: TOPS

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOPS; weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors	Behavioral: TOPS; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session		One-time invitation
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 12 Weeks	Measured by the number of women who reported to the 12-week weigh in.	up to 12 weeks
Number of Women Who Remained in the Program for 24 Weeks	Measured by the number of women who reported to the 24-week weigh in.	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change in Participants' Weight as Measured by Scale Reading	baseline, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Nia Mitchell, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): March 16, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Body Weight; Body Weight Changes; Breast Neoplasms; Weight Loss
• Other Study ID Numbers: Pro00107615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No