Planning Grant for TOPS for Breast Cancer Survivors

NCT06658912 | Not Yet Recruiting DMC

• 1 other identifier: Pro00116571
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Weight Loss

Outcome Measures

Primary Outcomes (6)

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

  1-2 months

• Percentage of TOPS group session attendance

  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

  3 months, 6 months, 9 months, 12 months

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

  12 months

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

  9 months, 12 months

• Percent of Weight Loss

  Up to 12 Months

Secondary Outcomes (5)

• Cardiovascular Disease (CVD) risk factors as measured by blood pressure

  up to 12 months

• Cardiovascular Disease (CVD) risk factors as measured by hemoglobin A1c

  up to 12 months

• Cardiovascular Disease (CVD) risk factors as measured by glucose

  up to 12 months

• Percentage of participants who get blood drawn

  Baseline, 3 months, 6 months,12 months

• Quality of Life (QOL) as measured by survey

  up to 12 months

Study Arms (1)

TOPS Classes

OTHER

Other: TOPS Classes

Interventions

TOPS Classes OTHER

Attend Dietician-Led Sessions

TOPS Classes

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Weight Loss

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nia S Mitchell, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nia S Mitchell, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)