N/A
Completed N=26
TOPS for African American Breast Cancer Survivors
Source: ClinicalTrials.gov NCT04741802 ↗Enrolled (actual)
26
Serious AEs
—
Results posted
Feb 2024
Primary outcomePrimary: Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session — 45 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session |
45 | — |
| PRIMARY Number of Women Who Attended the Information Session and Joined the TOPS Program |
26 | — |
| PRIMARY Number of Women Who Remained in the Program for 12 Weeks |
23 | — |
| PRIMARY Number of Women Who Remained in the Program for 24 Weeks |
18 | — |
| SECONDARY Percent Change in Participants' Weight as Measured by Scale Reading |
-2.6; -3.5; -6.4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04741802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.