Clinical trial NCT04741802: TOPS for African American Breast Cancer Survivors
Official title: Feasibility and Acceptability of a Community-based Weight Loss Program Among African American Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility and Acceptability of the TOPS Program
Obesity
Breast Cancer
Weight Loss
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-02-05
Enrollment: 26
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 (randomized controlled trial).


Eligibility 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.

Primary outcomes:
measure: Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session
timeFrame: One-time invitation
measure: Number of Women Who Attended the Information Session and Joined the TOPS Program
timeFrame: One-time information session
measure: Number of Women Who Remained in the Program for 12 Weeks
timeFrame: up to 12 weeks
measure: Number of Women Who Remained in the Program for 24 Weeks
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Percent Change in Participants' Weight as Measured by Scale Reading
timeFrame: baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Nia Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References: