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NCT06772181 | RECRUITING | Anatomic Stage 0 Breast Cancer AJCC v8

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

University of Washington

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.

Condition or disease

Anatomic Stage 0 Breast Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer Ajc V8

Anatomic Stage III Breast Cancer AJCC v8

Breast Carcinoma

Intervention/treatment

Cardio fitness, Yoga, Tai Chi, Qigong, Dance Cardio, Guided Meditation, Music Therapy

Medical Device Usage and Evaluation

Questionnaire Administration

Phase

NA

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
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
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)
Actual Study Start Date : 2025-03-04
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).
A Digital Health Intervention to Improve Symptoms and Physical Activity During Breast Radiation

Location Details

NCT06772181

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Washington

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

NOT YET RECRUITING

United States, Washington

MultiCare Valley Hospital (Spokane)

Spokane Valley, Washington, United States, 99216