RecruitingNot Applicable

Planning Grant for TOPS for Breast Cancer Survivors

United States25 participantsStarted 2026-08-03

Plain-language summary

The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors. This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and provide feedback. Focus groups will be made up of women who are breast cancer survivors. The second part includes taking the feedback received from these focus groups and use this feedback to tailor TOPS classes for breast cancer survivors. This ClinicalTrials.gov record is specific to the second part of the study.

Who can participate

Age range

21 Years – 90 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of invitations sent through the electronic health record to get 25 individuals consented to the study

Timeframe: 1-2 months

Percentage of TOPS group session attendance

Timeframe: 12 months

Number of participants who stay in the study

Timeframe: 3 months, 6 months, 9 months, 12 months

Number of participants who transition from the initiation phase to the maintenance phase

Timeframe: 12 months

Number of participants who continue to transmit weight and BP data once they transition to the maintenance phase

Timeframe: 9 months, 12 months

Percent of Weight Loss

Timeframe: Up to 12 Months

Trial details

NCT IDNCT06658912

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Nia S Mitchell, MD

833-637-8839 nia.s.mitchell@duke.edu

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range

21 Years – 90 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of invitations sent through the electronic health record to get 25 individuals consented to the study

Timeframe: 1-2 months

Percentage of TOPS group session attendance

Timeframe: 12 months

Number of participants who stay in the study

Timeframe: 3 months, 6 months, 9 months, 12 months

Number of participants who transition from the initiation phase to the maintenance phase

Timeframe: 12 months

Number of participants who continue to transmit weight and BP data once they transition to the maintenance phase

Timeframe: 9 months, 12 months

Percent of Weight Loss

Timeframe: Up to 12 Months