Comprehensive Lifestyle Change To Prevent Breast Cancer

February 17, 2026 updated by: M.D. Anderson Cancer Center

Comprehensive Lifestyle Change to Prevent Breast Cancer: A Feasibility Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: Questionnaire Administration
Ancillary studies
Other: Cancer Prevention
Attend IO prevention program
Active Comparator: Group II (no intervention)
Patients receive no intervention. After 26 weeks, patients may crossover to Group I.
Other: Questionnaire Administration
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Consent rate
Time Frame: Up to 1 year
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
Time Frame: Up to 1 year
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
Time Frame: Up to 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Group differences over time in biological pathways
Time Frame: Up to 1 year
Will first conduct extensive descriptive analyses on the data collected at baseline and at each follow-up. Descriptive statistics including 90% CIs will be computed for the relevant measures. Will examine distribution characteristics of the variables using box plots, histograms, scatter plots, and the Kolmogorov-Smirnov test of normality where appropriate. Distribution assumptions will be evaluated, and if indicated, normalizing transformations or robust procedures will be used. Will evaluate bivariate associations between the outcome measures and selected demographic and medical variables, including age, ethnicity, body mass index, and cancer history using Pearson product-moment correlation coefficients, chi-squared tests, or other methods where appropriate. Will use generalized linear mixed model regression (GLMM). Separate sets of analyses will be conducted for each criterion variable.
Up to 1 year
Group differences over time in dietary patterns
Time Frame: Up to 1 year
Will first conduct extensive descriptive analyses on the data collected at baseline and at each follow-up. Descriptive statistics including 90% CIs will be computed for the relevant measures. Will examine distribution characteristics of the variables using box plots, histograms, scatter plots, and the Kolmogorov-Smirnov test of normality where appropriate. Distribution assumptions will be evaluated, and if indicated, normalizing transformations or robust procedures will be used. Will evaluate bivariate associations between the outcome measures and selected demographic and medical variables, including age, ethnicity, body mass index, and cancer history using Pearson product-moment correlation coefficients, chi-squared tests, or other methods where appropriate. Will use GLMM. Separate sets of analyses will be conducted for each criterion variable.
Up to 1 year
Group differences over time in fitness levels
Time Frame: Up to 1 year
Will first conduct extensive descriptive analyses on the data collected at baseline and at each follow-up. Descriptive statistics including 90% CIs will be computed for the relevant measures. Will examine distribution characteristics of the variables using box plots, histograms, scatter plots, and the Kolmogorov-Smirnov test of normality where appropriate. Distribution assumptions will be evaluated, and if indicated, normalizing transformations or robust procedures will be used. Will evaluate bivariate associations between the outcome measures and selected demographic and medical variables, including age, ethnicity, body mass index, and cancer history using Pearson product-moment correlation coefficients, chi-squared tests, or other methods where appropriate. Will use GLMM. Separate sets of analyses will be conducted for each criterion variable.
Up to 1 year
Group differences over time in percent body fat
Time Frame: Up to 1 year
Will first conduct extensive descriptive analyses on the data collected at baseline and at each follow-up. Descriptive statistics including 90% CIs will be computed for the relevant measures. Will examine distribution characteristics of the variables using box plots, histograms, scatter plots, and the Kolmogorov-Smirnov test of normality where appropriate. Distribution assumptions will be evaluated, and if indicated, normalizing transformations or robust procedures will be used. Will evaluate bivariate associations between the outcome measures and selected demographic and medical variables, including age, ethnicity, body mass index, and cancer history using Pearson product-moment correlation coefficients, chi-squared tests, or other methods where appropriate. Will use GLMM. Separate sets of analyses will be conducted for each criterion variable.
Up to 1 year
Group differences over time in anthropometrics
Time Frame: Up to 1 year
Will first conduct extensive descriptive analyses on the data collected at baseline and at each follow-up. Descriptive statistics including 90% CIs will be computed for the relevant measures. Will examine distribution characteristics of the variables using box plots, histograms, scatter plots, and the Kolmogorov-Smirnov test of normality where appropriate. Distribution assumptions will be evaluated, and if indicated, normalizing transformations or robust procedures will be used. Will evaluate bivariate associations between the outcome measures and selected demographic and medical variables, including age, ethnicity, body mass index, and cancer history using Pearson product-moment correlation coefficients, chi-squared tests, or other methods where appropriate. Will use GLMM. Separate sets of analyses will be conducted for each criterion variable.
Up to 1 year
Gut microbiome
Time Frame: Up to 1 year
Sequence processing and analysis will be performed using specific software for comparison and analysis of microbial communities.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lorenzo Cohen, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-0479 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2018-00915 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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