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Trial Title:
Planning Grant for TOPS for African American Breast Cancer Survivors
NCT ID:
NCT06658912
Condition:
Breast Cancer
Weight Loss
Conditions: Official terms:
Breast Neoplasms
Weight Loss
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
TOPS Classes
Description:
Attend Dietician-Led Sessions
Arm group label:
TOPS Classes
Summary:
The purpose of this study is to help make a community led weight loss program known as
Take Off Pounds Sensibly (TOPS) more relevant for African American breast cancer
survivors.
This study is made up to two parts. The first part includes using focus groups to review
current materials that the investigators plan to use in upcoming TOPS classes and provide
feedback. Focus groups will be made up of African American women who are breast cancer
survivors.
The second part includes taking the feedback received from these focus groups and use
this feedback to tailor TOPS classes for African American breast cancer survivors.
This ClinicalTrials.gov record is specific to the second part of the study.
Detailed description:
The purpose of this study is to help make a community led weight loss program known as
Take Off Pounds Sensibly (TOPS) more relevant for African American breast cancer
survivors.
This study is made up to two parts. The first part includes using focus groups to review
current materials that the investigators plan to use in upcoming TOPS classes and have
the groups provide feedback. Focus groups will be made up of African American breast
cancer survivors that have recruited from Sisters Network Triangle North Carolina
chapters. The goal is to recruit approximately 15 people to take part in these focus
groups. Meetings of focus groups will be conducted remotely through Zoom and will be
recorded. A meeting of the focus group will last anywhere from 60-90 minutes.
The information gathered from these groups will be used to improve the materials which
lead to part two of the study.
The second part includes using these materials in TOPS classes that are tailored for
African American breast cancer survivors and determining if the TOPS classes are
effective on those who attend the classes. Effectiveness of the class will be determined
by the weight loss of the participant and an impact on their heart health.
For the first 6 months, participants will attend dietician-led TOPS sessions conducted
virtually through Zoom. Participants' weight will be measured as instructed using a
Bluetooth scale that will send their weight measurements back to the team. Participants
will also measure their blood pressure as instructed with a Bluetooth blood pressure
cuff. After 6 months, participants will be asked to join a TOPS chapter in their
community. The study team will help them local a chapter that is convenient for them.
They must attend these classes for another 6 months. Total time in this portion of the
study will be approximately 12 months.
While on study, in addition to measuring their weight and blood pressure via the
Bluetooth devices, the study team asks that participants also have their blood collected.
Participants will have to go to their local LabCorp facility to have blood drawn at 3
months, 6 months, and 12 months.
This ClinicalTrials.gov record is specific to the second part of the study.
Criteria for eligibility:
Criteria:
Aim 2 Inclusion Criteria:
- African American women diagnosed with breast cancer with BMI ≥ 25 kg/m2 after
completion of primary therapy (surgery, radiation, adjuvant or neo-adjuvant
chemotherapy).
Aim 2 Exclusion Criteria:
- Those whose oncology providers do not agree with their participation in a weight
loss program
- those participating in another weight loss program
- those taking a weight loss medication
- those without smart phones or internet connections or the ability to attend meetings
via Zoom
Gender:
Female
Minimum age:
21 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Contact:
Last name:
Nia S Mitchell, MD
Phone:
833-637-8839
Email:
nia.s.mitchell@duke.edu
Start date:
December 2024
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06658912