A Digital Health Intervention to Improve Symptoms and Physical Activity During Breast Radiation (PRO-ACTIVE)

Multicenter Pilot Study: Leveraging Digital Health to Promote Evidence-Based Physical Activity to Improve Symptoms Among Patients Undergoing Radiation for Breast Cancer (PRO-ACTIVE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Interview; Other: Medical Device Usage and Evaluation; Behavioral: IM@Home Program

Detailed Description

OUTLINE:

REGISTRY: 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.

INTERVENTION: Patients 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
    • Spokane Valley, Washington, United States, 99216
      • MultiCare Valley Hospital (Spokane)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old.
• Ability to understand English, or has a caregiver who understands English.
• Ability to understand and willingness to sign a written informed consent document, virtually or in-person.
• Current breast cancer diagnosis.
• Currently receiving radiation with curative intent (including partial breast, whole breast, or regional nodal radiation).

Exclusion Criteria:

• Patients who are non-English speaking that would prevent their participation in IM@Home.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (IM@Home program); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Medical Device Usage and Evaluation; Wear a FitBit activity tracker; Behavioral: IM@Home Program; Participate in the IM@Home program delivered via Zoom
Experimental: Registry (FitBit, PRO surveys); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Medical Device Usage and Evaluation; Wear a FitBit activity tracker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible patients that consent to the screening registry (Feasibility)	Will be considered feasible, as designed, if over 50% of eligible patients consent to the screening registry. Will be determined using descriptive statistics.	Up to 6 months
Proportion of patients with fatigue or other comorbid symptoms enrolling to the Integrative Medicine at Home (IM@Home) virtual intervention (Acceptability)	Will be considered acceptable if 50% of patients reporting fatigue or other comorbid symptoms agree to enroll to the IM@Home intervention. Will be determined using descriptive statistics.	Up to 6 months
Proportion of patients enrolling in IM@Home virtual intervention that report favorable implementation outcomes (Appropriateness)	Will be assessed using a validated patient-reported outcomes (PRO) scale with responses as agree or completely agree. Will be determined using descriptive statistics.	At 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants meeting guideline recommendations for physical activity	Will be assessed using the Godin Leisure Time Exercise Questionnaire. Will be estimated, along with an exact binomial 95% confidence interval, though no formal statistical testing will be performed.	At baseline, 2, 4, 6, 8, 10, and 12 weeks
Relationship between self-reported and monitor-based physical activity	Will be evaluated graphically via a scatterplot and Bland-Altman plot. Pearson's correlation coefficient will be estimated for descriptive purposes.	At baseline, 2, 4, 6, 8, 10, and 12 weeks
Patient-reported fatigue	Will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Will be plotted graphically for all patients, showing those participating in IM@Home compared to those not assigned to IM@Home.	At baseline, 2, 4, 6, 8, 10, and 12 weeks
Sleep quality	Will be assessed using the Insomnia Severity Index. Paired T-tests will be assessed for significant within-patient differences in insomnia.	At baseline, 4, 8, and 12 weeks
Social isolation	Will be assessed using the Cancer Loneliness Scale. Paired T-tests will be assessed for significant within-patient differences in social isolation.	At baseline, 6, and 12 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Erin Gillespie, MD, MPH, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Actual): April 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: RG1124991; NCI-2024-10340 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No