Clinical trial · Interventional
Comprehensive Lifestyle Change To Prevent Breast Cancer
Comprehensive Lifestyle Change to Prevent Breast Cancer: A Feasibility Trial
NCT03448003CI-TRIAL-00121351active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 mindfulness training, learning sleep hygiene techniques, and behavioral counseling in addition to social support may help patients who may be at risk for breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Premenopausal | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cancer Prevention | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (IO prevention program)
- description
- 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.
- interventionNames
- Other: Cancer Prevention
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Group II (no intervention)
- description
- Patients receive no intervention. After 26 weeks, patients may crossover to Group I.
- interventionNames
- Other: Questionnaire Administration
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.