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Planning Grant for TOPS for Breast Cancer Survivors

This study is looking at how to make a community weight loss program called Take Off Pounds Sensibly (TOPS) more helpful for women who have had breast cancer. The study has two parts. The first part uses focus groups of breast cancer survivors to get feedback on TOPS materials. The second part, which this record focuses on, uses that feedback to create tailored TOPS classes. The goal is to see if these adapted classes are effective for weight loss and heart health. You might be able to join if you are a woman aged 21-90, have been diagnosed with breast cancer, and have a BMI (Body Mass Index) of 25 or higher after your main cancer treatment. The study aims to enroll 25 participants.

Study design
This is an interventional study with a planned enrollment of 25 women. It is focused on adapting and evaluating a weight loss program.
What's involved
You would attend dietician-led TOPS sessions virtually through Zoom for the first 6 months. Your weight would be measured using a Bluetooth scale.
Compensation
Not stated in the trial record.
Follow-up
Your participation in the study will be tracked for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06658912

Planning Grant for TOPS for Breast Cancer Survivors

Recruiting
NAAges 21–90InterventionalSupportive care
Duke University
~25 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:TOPS Classes

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of invitations sent through the electronic health record to get 25 individuals consented to the study
Measured over 1-2 months
+5 more outcomes measured

Conditions

Breast Cancer
Weight Loss

Explore related trials

Breast CarcinomaWeight Loss

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Nia S Mitchell, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Nia S Mitchell, MD
[email protected]
833-637-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

women diagnosed with breast cancer with BMI ≥ 25 kg/m2 after completion of primary therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).

Exclusion

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

What this trial measures

  • Number of invitations sent through the electronic health record to get 25 individuals consented to the study1-2 months
  • Percentage of TOPS group session attendance12 months

    This will be calculated as number of sessions attended divided by total number of sessions offered

  • Number of participants who stay in the study3 months, 6 months, 9 months, 12 months
  • Number of participants who transition from the initiation phase to the maintenance phase12 months
  • Number of participants who continue to transmit weight and BP data once they transition to the maintenance phase9 months, 12 months
  • Percent of Weight LossUp to 12 Months