TOPS for African American Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741802
• Other study ID #: Pro00107615
• Status: Completed
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 30, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Feasibility and Acceptability of the TOPS Program
• Obesity
• Weight Loss

Intervention

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).

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session		One-time invitation
Primary	Number of Women Who Attended the Information Session and Joined the TOPS Program		One-time information session
Primary	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
Primary	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	Percent Change in Participants' Weight as Measured by Scale Reading		baseline, 3 months, 6 months, 12 months