A Digital Health Intervention to Improve Symptoms and Physical Activity During Breast Radiation

NCT ID: NCT06772181

Last Updated: 2026-01-23

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-04

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

IM@Home Program

Intervention Type BEHAVIORAL

Participate in the IM@Home program delivered via Zoom

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear a FitBit activity tracker

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear a FitBit activity tracker

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Interventions

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IM@Home Program

Participate in the IM@Home program delivered via Zoom

Intervention Type BEHAVIORAL

Medical Device Usage and Evaluation

Wear a FitBit activity tracker

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

MultiCare Valley Hospital (Spokane)

Spokane Valley, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Gillespie, MD, MPH

Role: CONTACT

206-598-4100

Facility Contacts

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Erin Gillespie, MD, MPH

Role: primary

206-598-4100

Zachary Guss, MD, MsC

Role: primary

509-755-5783

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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