Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families

Running, not enrolling · Not applicable

Conditions studied: Hereditary Breast Carcinoma, Hereditary Ovarian Carcinoma, Lynch Syndrome

In brief

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.

Key facts

Study ID

NCT04125914

Run by

M.D. Anderson Cancer Center

People needed

384

Starts

2017-01-26

Expected to finish

2026-04-30

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• HEALTH4CPC only: Persons diagnosed with any invasive cancer excluding non-melanoma skin cancer.
• HEALTH4CPC only: Patient at high risk for cancer.
• HEALTH4CPC only: Participated in the HEALTH 4 MD Anderson pilot study (protocol 2014-0230).

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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