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Lifestyle Intervention for Metastatic Breast Cancer (EDC Trial)

N/A

Recruiting

Led By Melinda Stolley, PhD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Adult (≥ 18 years), female

Confirmed Metastatic Breast Cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore how diet and activity impact breast cancer patients' health, body composition, and quality of life. 176 women in Milwaukee & Chicago will be studied.

Who is the study for?

This trial is for adult women with metastatic breast cancer who don't follow ACS nutrition or physical activity guidelines, have a mobile phone, and permission from their oncologist to participate. They must be clinically stable even with treated brain metastases, not losing weight unintentionally, no new symptoms or worsening condition in the past month, and expected to live more than 6 months.

What is being tested?

The study tests a lifestyle program focusing on diet and exercise patterns against an attention control group. It aims to understand how these factors affect body composition, blood markers, and quality of life in women with metastatic breast cancer across two cities.

What are the potential side effects?

Since this is a lifestyle intervention study rather than medication-based treatment, side effects may include typical responses to changes in diet or exercise such as muscle soreness or digestive adjustments but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman aged 18 or older.

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My breast cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body composition

Change in Quality of Life

Intervention adherence

+1 more

Secondary study objectives

Serum Biomarker Adipokine Dysregulation - Adiponectin

Serum Biomarker Adipokine Dysregulation - Leptin

Serum Biomarker Inflammation - C-Reactive Protein

+5 more

Other study objectives

nRNA and Metabolomics - exploratory

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Immediate InterventionExperimental Treatment1 Intervention

The experimental arm will receive a 16-week lifestyle intervention that promotes nutritional and physical activity changes concordant with those contained in the ACS nutrition and physical activity guidelines for cancer survivors. The 16-week intervention includes: 1) a curriculum binder covering weekly topics and including self-monitoring tools to support adherence; 2) lifestyle coaching for 16-weeks, with in-person or virtual supervised exercise sessions and telephone-based sessions; 3) exercise supplies (Fitbit, resistance bands), 4) twice weekly text messaging targeting self-efficacy and social support; and 5) attendance to cooking classes emphasizing plant-based eating.

Group II: Attention ControlExperimental Treatment1 Intervention

The attention control participants will receive a home/work organization intervention: * Participants will receive a book with overview of home/work organization program with 16 weekly topics with an overview of each chapter. * Virtual or weekly phone calls- with a home organization coach with standard prompts. * Text messages supporting home/work organization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Attention Control

2014

Completed Phase 2

~6520

Lifestyle Intervention

2001

Completed Phase 3

~8370