TOPS for African American Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility and Acceptability of a Community-based Weight Loss Program Among African American Breast Cancer Survivors

Conditions
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Feasibility and Acceptability of the TOPS Program

Intervention / Treatment
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* Behavioral: TOPS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOPS<br>weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors | Behavioral: TOPS<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of invited women who attended the information session |  | 6 months | 
| Number of women who attended the information session that joined the TOPS program |  | 6 months | 
| Number of women who remained in the program for 12 weeks |  | Up to 12 weeks | 
| Number women who remained in the program for 24 weeks |  | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight as measured by scale reading |  | baseline, 3 months, 6 months, 12 months |