Planning Grant for TOPS for Breast Cancer Survivors

NCT ID: NCT06658912

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-09-30

Brief 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.

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.

Conditions

Breast Cancer; Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

TOPS Classes

Group Type: OTHER

TOPS Classes

Intervention Type: OTHER

Attend Dietician-Led Sessions

Interventions

TOPS Classes

Attend Dietician-Led Sessions

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nia S Mitchell, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Central Contacts

Nia S Mitchell, MD

Role: CONTACT

nia.s.mitchell@duke.edu

833-637-8839

Facility Contacts

Nia S Mitchell, MD

Role: primary

nia.s.mitchell@duke.edu

833-637-8839

Other Identifiers

Pro00116571

Identifier Type: -

Identifier Source: org_study_id