Mobile-Health Lifestyle Interventions for Breast Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Lorenzo G Cohen | MD Anderson Cancer Center

Overseen byLorenzo Cohen

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This clinical trial aims to develop a lifestyle program to improve clinical outcomes in women with breast cancer who do not have a healthy diet, regular exercise habits, or ways to manage their stress well. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, learning sleep hygiene techniques, and behavioral counseling in addition to social support. Developing a lifestyle program may help improve quality of life and encourage healthy lifestyle choices among patients diagnosed with breast cancer.

Eligibility Criteria

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.

Inclusion Criteria

This criterion means that participants need to have at least two of the listed lifestyle factors at the time of their diagnosis.

You have a body mass index (BMI) of 25 or more.

I am aware of who I am, where I am, and the current time.

+11 more

Exclusion Criteria

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

Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired)

You have a serious mental illness like schizophrenia or dementia.

+2 more

Participant Groups

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.

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.