Comprehensive Lifestyle Change in Preventing Patients from Breast Cancer
- Able to read, write, and speak English
- 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: * Consume less than 3 servings of vegetables per day, excluding any fried items. * 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); * Engage in a mind-body practice less than once per week
- Physically able 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
- 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)
I. Assess the feasibility of a randomized controlled trial involving a mobile, standardized, comprehensive integrative oncology (IO) prevention program.
I. Compare group differences over time in biological pathways including: immune function, gut microbiome, endocrine function, insulin and glucose metabolism, inflammation, other cancer-related pathways (from peripheral blood), antioxidant capacity, and nutrient levels.
II. Determine whether the IO group has improved patient reported outcomes over time including: quality of life, sleep disturbances, aspects of mental health, and psychosocial measures including: mindfulness, social support, and measures of positive growth.
III. Compare group differences over time in dietary patterns, fitness levels, percent body fat, and anthropometrics.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients attend IO prevention program consisting of 1-2 physical activity, nutrition and diet, and mind-body practice sessions over 60 minutes weekly for 12 weeks. Patients also attend a behavioral counseling session once weekly for up to 26 weeks. Patients complete exercises over 30-60 minutes 3-5 times weekly for 12 weeks.
GROUP II: Patients receive no intervention. After 26 weeks, patients may crossover to Group I.
After completion of study, patients are followed up at 26 weeks and 1 year.
Trial Phase Phase NA
Trial Type Prevention
M D Anderson Cancer Center
- Primary ID 2017-0479
- Secondary IDs NCI-2018-00915
- Clinicaltrials.gov ID NCT03448003