Telehealth Weight Loss Program for Breast Cancer Survivors (NCT04855552) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Telehealth Weight Loss Program for Breast Cancer Survivors
United States22 participantsStarted 2021-07-19
Plain-language summary
This is a single-arm longitudinal group to examine patient-reported outcomes, body mass and mammographic density changes pre- and post- weight loss intervention of breast cancer survivors using video conferencing telehealth visits.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* History of in situ or invasive breast cancer
* Have completed breast cancer surgery, adjuvant cytotoxic chemotherapy (as indicated) and adjuvant radiation therapy (as indicated) at least 6-months prior to enrollment
* Not on active treatment for other cancer for at least 6-months prior to enrollment
* Currently cancer free
* Overweight or obese (BMI of 25 kg/m\^2 or greater)
* Have internet access and videoconferencing capability
Exclusion Criteria:
* Current use of weight loss medication (OTC or prescription) or participation in behavioral weight loss program
* Currently participating in a behavioral weight loss program
* Self-report of alcohol or substance abuse within the past 12-months, including at-risk drinking (current consumption of more than 14 drinks per week)
* Undergone bilateral mastectomy
* History of Bulimia nervosa
* Inability to provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine feasibility and Acceptability Using the City of Hope Quality of Life Instrument - Breast Cancer Patient to Assess Changes in Quality of Life
Timeframe: 24 weeks
2
Determine feasibility and Acceptability Using the International Physical Activity Questionnaire to Assess Changes in Physical Activity
Timeframe: 24 weeks
3
Determine feasibility and Acceptability Using the Patient Health Questionnaire to Assess Changes in Measures of Depression
Timeframe: 24 weeks
4
Using the Acceptability of Intervention Measure to Assess Acceptability and Feasibility
Timeframe: 24 weeks
5
Requesting Direct Verbal Feedback From Participants to Assess Elements of the Program that Work Well, to Acquire Suggestions, and to Seek Suggestions to Determine Feasibility and Acceptability