Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT03448003
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03448003
Study Brief:
Protocol Section:
NCT03448003