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

University of Washington

Status: Enrolling

Conditions: Breast Carcinoma

Treatments: Other: Medical Device Usage and Evaluation; Behavioral: IM@Home Program; Other: Interview; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT06772181

NCI-2024-10340 (Registry Identifier)

RG1124991

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention (IM@Home program)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Interview

Behavioral: IM@Home Program

Other: Medical Device Usage and Evaluation

Registry (FitBit, PRO surveys)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Interview

Other: Medical Device Usage and Evaluation