Clinical trial NCT06658912: Planning Grant for TOPS for African American Breast Cancer Survivors
Official title: Planning Grant for Take Off Pounds Sensibly (TOPS) Classes for African American Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Weight Loss
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 25
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 through a Bluetooth device provided by the study team.

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 baseline visit, 3 months, 6 months, and 12 months. Participants will also be asked to complete surveys via their email. Surveys will ask about participant's current medications and ask them to score their overall health at that time.

This ClinicalTrials.gov record is specific to the second part of the study.

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
* History of Type II Diabetes Mellitus
* 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

Primary outcomes:
measure: Number of invitations sent through the electronic health record to get 25 individuals consented to the study
timeFrame: 1-2 months
measure: Percentage of TOPS group session attendance
timeFrame: 12 months
measure: Number of participants who stay in the study
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Number of participants who transition from the initiation phase to the maintenance phase
timeFrame: 12 months
measure: Number of participants who continue to transmit weight and BP data once they transition to the maintenance phase
timeFrame: 9 months, 12 months
measure: Percent of Weight Loss
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Cardiovascular Disease (CVD) risk factors as measured by blood pressure
timeFrame: up to 12 months
measure: Cardiovascular Disease (CVD) risk factors as measured by hemoglobin A1c
timeFrame: up to 12 months
measure: Cardiovascular Disease (CVD) risk factors as measured by glucose
timeFrame: up to 12 months
measure: Percentage of participants who get blood drawn
timeFrame: Baseline, 3 months, 6 months,12 months
measure: Quality of Life (QOL) as measured by survey
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Nia S Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References: