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OpenTrials
Completed

NCT Number: NCT04741802

TOPS for African American Breast Cancer Survivors

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

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

    Time frame: One-time invitation

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

    Time frame: One-time information session

  3. Number of Women Who Remained in the Program for 12 Weeks

    Time frame: up to 12 weeks

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

  4. Number of Women Who Remained in the Program for 24 Weeks

    Time frame: up to 24 weeks

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

Secondary outcomes

  1. Percent Change in Participants' Weight as Measured by Scale Reading

    Time frame: baseline, 3 months, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2021
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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