Tailoring TOPS for breast cancer survivors
Official title: Planning Grant for Take Off Pounds Sensibly (TOPS) Classes for Breast Cancer Survivors
Run by Duke University · NCT06658912 · Data updated 2026-11-12
Aims to see if a community-based weight loss program (TOPS) can be made more relevant for women who have survived breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 90 Years |
| Sex | Women only |
| Enrollment | 25 (estimated) |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | August 3, 2026 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT06658912 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with a history of breast cancer, BMI ≥ 25 kg/m2 after completion of primary therapy, and access to Zoom/internet who are willing to participate.
✕Probably not a fit
Those who do not experience weight loss or who cannot engage with remote sessions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project has two parts, with the second part focusing on adapting TOPS materials for breast cancer survivors based on feedback from focus groups. Focus groups consisting of breast cancer survivors will review current TOPS content and remote sessions will be used to gather their input. The adapted TOPS classes will then be delivered virtually for six months, with outcomes assessed by weight changes and heart-health indicators. Participants will follow dietitian-led TOPS sessions via Zoom and have weights and blood pressure tracked with Bluetooth devices. Eligibility targets women with BMI 25 or higher after completing primary breast cancer therapy, who have access to a smartphone or internet and are willing to participate remotely.
Why it matters
Potential benefit: If successful, survivors may experience more relevant support for weight loss and improved cardiovascular health through a tailored TOPS program.
How similar studies have gone: Past efforts show community-based weight loss programs can aid participants, but tailoring to cancer survivors is a newer approach with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Aim 2 Inclusion Criteria: * women diagnosed with breast cancer with BMI ≥ 25 kg/m2 after completion of primary therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy). Aim 2 Exclusion Criteria: * Those whose oncology providers do not agree with their participation in a weight loss program * History of Type II Diabetes Mellitus * those participating in another weight loss program * those taking a weight loss medication * those without smart phones or internet connections or the ability to attend meetings via Zoom
Where it's running
-
Duke University
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Nia S Mitchell, MD — Duke University
- Study coordinator: Nia S Mitchell, MD
- Email: nia.s.mitchell@duke.edu
- Phone: 833-637-8839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.