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NCT04741802 · ClinicalTrials.gov registry record · NA
TOPS for African American Breast Cancer Survivors
A NA study of Breast Cancer and Obesity, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT04741802 is a NA study of Breast Cancer and Obesity that has completed, run by Duke University. The registered enrollment target is 26 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04741802, a NA study of Breast Cancer and Obesity, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- BEHAVIORAL TOPS
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-06-11 |
| Est. Completion | 2022-08-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04741802
The ClinicalTrials.gov registry entry for NCT04741802 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which TOPS is the first listed.
NCT04741802 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04741802 about?
NCT04741802 is a clinical study titled "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 a...
What is the current status of trial NCT04741802?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2021-06-11. Estimated completion is 2022-08-30.
What conditions does trial NCT04741802 study?
This clinical trial studies the following conditions: Breast Cancer, Obesity, Weight Loss, Feasibility and Acceptability of the TOPS Program.
What interventions are being tested in trial NCT04741802?
The interventions under investigation include: TOPS (BEHAVIORAL).
Who is sponsoring clinical trial NCT04741802?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04741802 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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