Clinical trial NCT06772181: A Digital Health Intervention to Improve Symptoms and Physical Activity During Breast Radiation
Official title: Multicenter Pilot Study: Leveraging Digital Health to Promote Evidence-Based Physical Activity to Improve Symptoms Among Patients Undergoing Radiation for Breast Cancer (PRO-ACTIVE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Breast Carcinoma
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.
* Patients with metastatic disease (i.e. stage IV).

Primary outcomes:
measure: Proportion of eligible patients that consent to the screening registry (Feasibility)
timeFrame: Up to 6 months
measure: Proportion of patients with fatigue or other comorbid symptoms enrolling to the Integrative Medicine at Home (IM@Home) virtual intervention (Acceptability)
timeFrame: Up to 6 months
measure: Proportion of patients enrolling in IM@Home virtual intervention that report favorable implementation outcomes (Appropriateness)
timeFrame: At 12 weeks
Secondary outcomes:
measure: Proportion of participants meeting guideline recommendations for physical activity
timeFrame: At baseline, 2, 4, 6, 8, 10, and 12 weeks
measure: Relationship between self-reported and monitor-based physical activity
timeFrame: At baseline, 2, 4, 6, 8, 10, and 12 weeks
measure: Patient-reported fatigue
timeFrame: At baseline, 2, 4, 6, 8, 10, and 12 weeks
measure: Sleep quality
timeFrame: At baseline, 4, 8, and 12 weeks
measure: Social isolation
timeFrame: At baseline, 6, and 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
city: Spokane Valley
country: United States
facility: MultiCare Valley Hospital (Spokane)
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Erin Gillespie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: