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Behavioural Intervention

Lifestyle Changes to Prevent Breast Cancer

N/A

Waitlist Available

Led By Lorenzo Cohen

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Premenopausal

Have intact breasts and ovaries

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing whether a comprehensive lifestyle change program can help prevent breast cancer. The program includes dietary recommendations, physical activity, stress management, mindfulness training, sleep hygiene techniques, and behavioral counseling.

Who is the study for?

This trial is for premenopausal women with a BMI of 25 or higher, who have intact breasts and ovaries, can read and speak English, have internet access, and can visit UT MD Anderson for sessions. They should eat few fruits/veggies, exercise less than 150 minutes per week, rarely practice mind-body techniques. Excluded are those with any cancer history (except non-melanoma skin cancers), current pregnancy or plans to become pregnant soon.Check my eligibility

What is being tested?

The study tests if a comprehensive lifestyle change program including diet advice, physical activity, stress management/mindfulness training, sleep hygiene techniques and behavioral counseling plus social support can prevent breast cancer in at-risk premenopausal women.See study design

What are the potential side effects?

Since this trial involves lifestyle changes rather than medication or medical procedures, side effects may include muscle soreness from new physical activities or temporary discomfort adjusting to dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not gone through menopause.

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I have not had surgery to remove my breasts or ovaries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Consent rate

Retention rate

Treatment group compliance rate

Secondary outcome measures

Group differences over time in anthropometrics

Group differences over time in biological pathways

Group differences over time in dietary patterns

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (IO prevention program)Experimental Treatment2 Interventions

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: Group II (no intervention)Active Control1 Intervention

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

0 / 2Eligibility criteria met