Status:
ACTIVE_NOT_RECRUITING
Comprehensive Lifestyle Change To Prevent Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Premenopausal
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This trial studies how well comprehensive lifestyle change works in preventing patients from breast cancer. A program including dietary recommendations, physical activity, stress management and mindfu...
Detailed Description
PRIMARY OBJECTIVES: I. Assess the feasibility of a randomized controlled trial involving a mobile, standardized, comprehensive integrative oncology (IO) prevention program. SECONDARY OBJECTIVES: I....
Eligibility Criteria
Inclusion
- Able to read, write, and speak English
- Premenopausal
- A body mass index (BMI) \>= 25
- Have intact breasts and ovaries
- Able to provide informed consent to participate in the study
- Meet all the following criteria related to lifestyle: a) consume less than 3 servings of vegetables (excluding any fried servings) and 1 serving of fruit (not including juice)/day; b) engage in less than 150 minutes moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling); c) engage in a mind-body practice less once per week
- Able mentally and physically to participate in interventions in this study (Note: If there are one or more positive responses to the Physical Activity Readiness Questionnaire \[PARQ\], then a physician-release for exercise is required prior to obtaining consent)
- Access to internet connection
- Able to come to University of Texas (UT) MD Anderson for the orientation and assessment sessions
Exclusion
- Any personal history of cancer, including ductal carcinoma in situ (DCIS) and not including non-melanoma skin cancers
- Any major thought disorder (e.g., schizophrenia, dementia)
- Communication barriers (e.g. hard of hearing)
- Poorly or uncontrolled diabetes in the opinion of the physician(s)
- Being pregnant or planning on becoming pregnant within the next year
- Contemplating any new pharmacologic/hormonal or prophylactic surgical intervention for breast cancer prevention within the next year (Note: Individuals taking tamoxifen, arimidex or other hormonal prevention strategies at time of consent will be eligible)
Key Trial Info
Start Date :
April 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03448003
Start Date
April 4 2019
End Date
August 31 2027
Last Update
August 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030