Status:
ACTIVE_NOT_RECRUITING
Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hereditary Breast Carcinoma
Hereditary Ovarian Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. Identify the most effective intervention components for weight loss (primary outcome) and percent energy from fat, vegetable and fruit consumption, physical activity, and theor...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT04125914
Start Date
January 26 2017
End Date
April 30 2026
Last Update
November 3 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030