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TOPS for African American Breast Cancer Survivors

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Duke University

Status

Completed

Conditions

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

Treatments

Behavioral: TOPS

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04741802
Pro00107615

Details and patient eligibility

About

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).

Enrollment

26 patients

Sex

Female

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women diagnosed with breast cancer with BMI ≥ 25 kg/m after completion of primary 2 therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).

Exclusion criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

TOPS
Experimental group
Description:
weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors
Treatment:
Behavioral: TOPS

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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