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Mobile-Health Lifestyle Interventions for Breast Cancer

N/A

Waitlist Available

Led By Lorenzo Cohen, MD

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

18 years of age or older

Be older than 18 years old

Must not have

Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 months after study baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is developing a lifestyle program to improve outcomes in women with breast cancer who don't have healthy diets, regular exercise, or ways to manage stress. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, sleep hygiene, and behavioral counseling.

Who is the study for?

This trial is for women over 18 with stage I-III breast cancer who've finished chemotherapy and surgery. They should have a BMI of 25 or higher, engage in little physical activity, eat less than three servings of fruits and vegetables daily, and not practice stress management often. Participants must be able to read English, use the internet, perform light exercise (with medical clearance if needed), and visit certain locations for blood collection.

What is being tested?

The study tests a lifestyle program designed to improve diet, increase physical activity using FitBit trackers, teach stress management through mindfulness practices, enhance sleep hygiene techniques, provide behavioral counseling and social support. The goal is to see if this program can boost quality of life for breast cancer survivors.

What are the potential side effects?

Since this trial focuses on lifestyle changes rather than medication or invasive procedures, side effects are minimal but may include muscle soreness from new physical activities or emotional discomfort during counseling sessions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot get in and out of a chair without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 months after study baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 months after study baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months after study baseline for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa.

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

Active Control

Group I: GROUP I (CLIP)Experimental Treatment5 Interventions

Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).

Group II: GROUP II (usual care)Active Control2 Interventions

Patients have access to all usual care supportive services.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Intervention

2021

Completed Phase 4

~3740

FitBit

2017