Planning Grant for TOPS for Breast Cancer Survivors

August 3, 2026 updated by: Duke University

Planning Grant for Take Off Pounds Sensibly (TOPS) Classes for Breast Cancer Survivors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 have the groups provide feedback. Focus groups will be made up of breast cancer survivors that have recruited from local support group chapters. The goal is to recruit approximately 25 people to take part in these focus groups. Meetings of focus groups will be conducted remotely through Zoom and will be recorded. A meeting of the focus group will last anywhere from 60-90 minutes.

The information gathered from these groups will be used to improve the materials which lead to part two of the study.

The second part includes using these materials in TOPS classes that are tailored for breast cancer survivors and determining if the TOPS classes are effective on those who attend the classes. Effectiveness of the class will be determined by the weight loss of the participant and an impact on their heart health.

For the first 6 months, participants will attend dietician-led TOPS sessions conducted virtually through Zoom. Participants' weight will be measured as instructed using a Bluetooth scale that will send their weight measurements back to the team. Participants will also measure their blood pressure through a Bluetooth device provided by the study team.

After 6 months, participants will be asked to join a TOPS chapter in their community. The study team will help them local a chapter that is convenient for them. They must attend these classes for another 6 months. Total time in this portion of the study will be approximately 12 months.

While on study, in addition to measuring their weight and blood pressure via the Bluetooth devices, the study team asks that participants also have their blood collected. Participants will have to go to their local LabCorp facility to have blood drawn at baseline visit, 3 months, 6 months, and 12 months. Participants will also be asked to complete surveys via their email. Surveys will ask about participant's current medications and ask them to score their overall health at that time.

This ClinicalTrials.gov record is specific to the second part of the study.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TOPS Classes
Other: TOPS Classes
Attend Dietician-Led Sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of invitations sent through the electronic health record to get 25 individuals consented to the study
Time Frame: 1-2 months
1-2 months
Percentage of TOPS group session attendance
Time Frame: 12 months
This will be calculated as number of sessions attended divided by total number of sessions offered
12 months
Number of participants who stay in the study
Time Frame: 3 months, 6 months, 9 months, 12 months
3 months, 6 months, 9 months, 12 months
Number of participants who transition from the initiation phase to the maintenance phase
Time Frame: 12 months
12 months
Number of participants who continue to transmit weight and BP data once they transition to the maintenance phase
Time Frame: 9 months, 12 months
9 months, 12 months
Percent of Weight Loss
Time Frame: Up to 12 Months
Up to 12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular Disease (CVD) risk factors as measured by blood pressure
Time Frame: up to 12 months
up to 12 months
Cardiovascular Disease (CVD) risk factors as measured by hemoglobin A1c
Time Frame: up to 12 months
up to 12 months
Cardiovascular Disease (CVD) risk factors as measured by glucose
Time Frame: up to 12 months
up to 12 months
Percentage of participants who get blood drawn
Time Frame: Baseline, 3 months, 6 months,12 months
Baseline, 3 months, 6 months,12 months
Quality of Life (QOL) as measured by survey
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Nia S Mitchell, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00116571

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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