A Digital Health Intervention to Improve Symptoms and Physical Activity During Breast Radiation
NCT ID: NCT06772181
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-03-04
2026-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
IM@Home Program
Participate in the IM@Home program delivered via Zoom
Medical Device Usage and Evaluation
Wear a FitBit activity tracker
Questionnaire Administration
Ancillary studies
Interview
Ancillary studies
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.
Medical Device Usage and Evaluation
Wear a FitBit activity tracker
Questionnaire Administration
Ancillary studies
Interview
Ancillary studies
Interventions
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IM@Home Program
Participate in the IM@Home program delivered via Zoom
Medical Device Usage and Evaluation
Wear a FitBit activity tracker
Questionnaire Administration
Ancillary studies
Interview
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Washington
OTHER
Responsible Party
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Principal Investigators
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Erin Gillespie, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
MultiCare Valley Hospital (Spokane)
Spokane Valley, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2024-10340
Identifier Type: REGISTRY
Identifier Source: secondary_id
RG1124991
Identifier Type: -
Identifier Source: org_study_id
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