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TOPS for African American Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04741802
Recruitment Status : Active, not recruiting
First Posted : February 5, 2021
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Duke University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Feasibility and Acceptability of the TOPS Program Behavioral: TOPS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Acceptability of a Community-based Weight Loss Program Among African American Breast Cancer Survivors
Actual Study Start Date : June 11, 2021
Estimated Primary Completion Date : February 17, 2022
Estimated Study Completion Date : August 17, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TOPS
weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors
 Behavioral: TOPS
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).


Outcome Measures
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Primary Outcome Measures :
  1. Number of invited women who attended the information session [ Time Frame: 6 months ]
  2. Number of women who attended the information session that joined the TOPS program [ Time Frame: 6 months ]
  3. Number of women who remained in the program for 12 weeks [ Time Frame: Up to 12 weeks ]
  4. Number women who remained in the program for 24 weeks [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Change in weight as measured by scale reading [ Time Frame: baseline, 3 months, 6 months, 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04741802


Locations
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United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Nia Mitchell, MD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol and Informed Consent Form  [PDF] June 2, 2021

More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04741802    
Other Study ID Numbers: Pro00107615
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No