TOPS for African American Breast Cancer Survivors

NCT04741802 | Completed Results

• 1 other identifier: Pro00107615
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

For women diagnosed with breast cancer, dietary, weight loss, and physical activity have been linked with clinically significant weight loss; decreased risk of death; reduced risk of breast cancer recurrence; fewer cardiovascular events; and improved physical function. The objectives of these aims are to a) determine if the TOPS materials and format are possible and accepted by overweight and obese African American breast cancer survivors; b) gather data for sample size calculations for a larger future study. To meet these aims, we will collect data to see if participants enjoyed the TOPS program and suggestions for changes to the program to make it fit their needs. Other methods will measure recruitment, retention, and weight change. Aim 1: Examine the feasibility and acceptability of a national, low-cost, community-based, peer-led, weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC). Aim 2: Assess the weight change of overweight and obese African American breast cancer survivors after 6 months in the TOPS program to gather data for sample size calculations for a future RCT (randomized controlled trial).

Conditions

Feasibility and Acceptability of the TOPS Program; Obesity; Breast Cancer; Weight Loss

Outcome Measures

Primary Outcomes (4)

• Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session

  One-time invitation

• Number of Women Who Attended the Information Session and Joined the TOPS Program

  One-time information session

• Number of Women Who Remained in the Program for 12 Weeks

  Measured by the number of women who reported to the 12-week weigh in.

  up to 12 weeks

• Number of Women Who Remained in the Program for 24 Weeks

  Measured by the number of women who reported to the 24-week weigh in.

  up to 24 weeks

Secondary Outcomes (1)

• Percent Change in Participants' Weight as Measured by Scale Reading

  baseline, 3 months, 6 months, 12 months

Study Arms (1)

TOPS

EXPERIMENTAL

weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors

Behavioral: TOPS

Interventions

TOPS BEHAVIORAL

weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC).

TOPS

Eligibility Criteria

• Age: 55 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/m after completion of primary 2 therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).

You may not qualify if:

• Women whose oncology providers do not agree with their participation in a weight loss program or those participating in another weight loss program.

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Obesity; Breast Neoplasms; Weight Loss

Interventions

TOPS

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes

Results Point of Contact

• Title: Nia S. Mitchell, MD, MPH
• Organization: Duke University

nia.s.mitchell@duke.edu

919-668-7202

Study Officials

• Nia Mitchell, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: February 2, 2021
• First Posted: February 5, 2021
• Study Start: June 11, 2021
• Primary Completion: March 16, 2022
• Study Completion: August 30, 2022
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)