NCT06658912 · Duke University
Planning Grant for TOPS for Breast Cancer Survivors
What this study is about
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 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.
View original scientific 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 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 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 breast cancer survivors. This ClinicalTrials.gov record is specific to the second part of the study.
Interventions
OTHER
TOPS Classes
Attend Dietician-Led Sessions
Primary outcome measures
Number of invitations sent through the electronic health record to get 25 individuals consented to the study
Time frame: 1-2 months
Percentage of TOPS group session attendance
Time frame: 12 months
This will be calculated as number of sessions attended divided by total number of sessions offered
Number of participants who stay in the study
Time frame: 3 months, 6 months, 9 months, 12 months
Number of participants who transition from the initiation phase to the maintenance phase
Time frame: 12 months
Number of participants who continue to transmit weight and BP data once they transition to the maintenance phase
Time frame: 9 months, 12 months
Percent of Weight Loss
Time frame: Up to 12 Months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations