Digital Health Intervention for Breast Cancer (PRO-ACTIVE Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByErin Gillespie, MD, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Washington

No Placebo Group

Trial Summary

What is the purpose of this trial?This clinical trial evaluates a digital health intervention for improving symptoms and physical activity among patients with breast cancer undergoing radiation. Cancer-related fatigue is common and strongly associated with quality of life during and after treatment. Increasing emphasis on early symptom detection and management has prompted initiatives to collect patient-reported fatigue from all patients during treatment. Mind-body interventions including physical activity and yoga are recommendations to treat fatigue and comorbid (coexisting) symptoms. Lower socioeconomic status has not only been associated with higher rates of physical inactivity but also with perceptions that it could negatively impact fatigue and quality of life during treatment. A virtual mind-body program called Integrative Medicine at Home (IM@Home) includes cardio fitness and yoga classes in a bundled intervention that has demonstrated decreased fatigue, depression, insomnia, and symptom distress among patients undergoing breast radiation. The IM@Home program may also increase physical activity among patients with breast cancer undergoing radiation.

Eligibility Criteria

This trial is for patients with breast cancer, including Ductal Carcinoma In Situ and Lobular Carcinoma in Situ, who are undergoing radiation therapy. It aims to help those experiencing fatigue and looking to improve their quality of life during treatment.

Inclusion Criteria

I have been diagnosed with breast cancer.

I am currently undergoing radiation therapy aimed at curing my cancer.

I am 18 years old or older.

Exclusion Criteria

My cancer has spread to other parts of my body.

I am not able to participate in IM@Home due to language barriers.

Participant Groups

The study tests a digital health program called IM@Home that offers mind-body interventions like cardio fitness, yoga, Tai Chi, Qigong, dance cardio, guided meditation, music therapy along with questionnaire feedback and medical device evaluation.

2Treatment groups

Experimental Treatment

Group I: Registry (FitBit, PRO surveys)Experimental Treatment2 Interventions

Patients receive a FitBit activity tracker and complete patient-reported outcomes (PRO) surveys every 2 weeks (Q2W) to monitor fatigue, comorbid symptoms, and physical activity during and immediately after radiation therapy. Patients with presence of self-reported symptoms or physical inactivity at baseline and/or from any Q2W PRO surveys are then invited to participate and register for IM@Home.

Group II: Intervention (IM@Home program)Experimental Treatment3 Interventions

A subset of patients in the registry will participate in the IM@Home program consisting of 20+ live, virtual mind-body and fitness classes ranging from yoga and tai chi to dance cardio, guided meditation, and music therapy delivered via Zoom over 30-60 minutes. Patients are instructed to complete at least 3 classes per week for 12 weeks.