Comprehensive Lifestyle Change To Prevent Breast Cancer

NCT ID: NCT03448003

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2027-08-31

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.

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. 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.

Conditions

Premenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group I (IO prevention program)

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 Type: EXPERIMENTAL

Cancer Prevention

Intervention Type: OTHER

Attend IO prevention program

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Group II (no intervention)

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

Group Type: ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Cancer Prevention

Attend IO prevention program

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Cohen

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2018-00915

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-0479

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0479

Identifier Type: -

Identifier Source: org_study_id