Comprehensive Lifestyle Change To Prevent Breast Cancer

NCT03448003 | Active Not Recruiting

• 2 other identifiers: 2017-0479NCI-2018-00915
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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

Premenopausal

Outcome Measures

Primary Outcomes (3)

• Consent rate

  Will calculate the rates, frequencies, and 90% confidence intervals (CIs) of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.

  Up to 1 year

• Treatment group compliance rate

  Will be defined as attending at least 50% of sessions during the intervention delivery weeks (first 26 weeks) in the integrative oncology (IO) group. Will calculate the rates, frequencies, and 90% CIs of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.

  Up to 1 year

• Retention rate

  Will calculate the rates, frequencies, and 90% CIs of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.

  Up to 1 year

Secondary Outcomes (6)

• Group differences over time in biological pathways

  Up to 1 year

• Group differences over time in dietary patterns

  Up to 1 year

• Group differences over time in fitness levels

  Up to 1 year

• Group differences over time in percent body fat

  Up to 1 year

• Group differences over time in anthropometrics

  Up to 1 year

Study Arms (2)

Group I (IO prevention program)

EXPERIMENTAL

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.

Other: Cancer Prevention; Other: Questionnaire Administration

Group II (no intervention)

ACTIVE COMPARATOR

Patients receive no intervention. After 26 weeks, patients may crossover to Group I.

Other: Questionnaire Administration

Interventions

Cancer Prevention OTHER

Attend IO prevention program

Group I (IO prevention program)

Questionnaire Administration OTHER

Ancillary studies

Group I (IO prevention program); Group II (no intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Study Officials

• Lorenzo Cohen

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 27, 2018
• Study Start: April 4, 2019
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)