Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and … (NCT04125914) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families
United States384 participantsStarted 2017-01-26
Plain-language summary
This trial studies how well weight management and health behavior intervention works in helping patients with hereditary breast and ovarian cancer and Lynch syndrome mutation carriers lose or maintain a healthy weight and lower their risk for cancer. Lifestyle behaviors such as physical activity, diet, and weight management may play a key role in preventing cancers and improving outcomes even in those with hereditary cancer syndromes.
Who can participate
Age range
18 Years
Sex
ALL
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:
* HEALTH4Families only: Positive for either HBOC or LS predisposing mutations OR a family member of a mutation carrier (family members do not need to be biological relatives).
* HEALTH4Families only: Index participant ONLY: Must have at least one family member who is eligible and consents to participation.
* Have at least one of the following risk factors:
* Body mass index (BMI) of 25 or higher
* \< 5 servings of vegetables and fruits per day
* \< 150 minutes per week of moderate intensity activity
* 75 minutes per week of vigorous intensity activity
* Able to read and write English.
* Have a cellular telephone and are able and willing to send and receive text messages.
* Access to internet via desktop or mobile device.
* Capable of participating in moderate-vigorous unsupervised exercise.
* HEALTH4CPC only: Patient in MD Anderson's Cancer Prevention Center coming in to the clinic for one of the following appointment types: consult and new patient screening appointments
* HEALTH4CPC only: Female.
* HEALTH4CPC only: Lives in the Houston area or surrounding counties (within 150 miles of MD Anderson's main campus).
* HEALTH4CPC only: Has a smartphone.
Exclusion Criteria:
* Unable to walk without crutches, walker, cane, or other assistive device.
* Women who are pregnant or nursing (by self-report).
* Currently receiving radiation therapy or cytotoxic chemotherapy.
* Within 3 months of major surgery.
* Does not live in the United States.
* HEALTH4…
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.