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

Study acronym: PRO-ACTIVE
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 1 of 2 sites
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion moved earlier from May 31, 2026 to Apr 30, 2026
    • Site details revised at 2 of 2 sites
    v9
  3. Primary completion date: Dec 31, 2025 to May 31, 2026v8
  4. Site details revised at 1 of 2 sitesv7
  5. Enrollment target: 30 to 40
    • Interventions: Cardio fitness, Yoga, Tai Chi, Qigong, Dance Cardio, Guided Meditation, Music Therapy (Behavioral), Medical Device Usage and Evaluation… to IM@Home Program (Behavioral), Interview (Other), Medical Device Usage and Evaluation (Other), Questionnaire Administration (Other)
    • Eligibility criteria shortened, about 7 words
    v6
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  1. Primary completion date: Sep 30, 2025 to Dec 31, 2025
    • Study completion date: Dec 31, 2025 to Sep 30, 2026
    v5
  2. Study sites: 1 to 2v4
  3. Start date changed from estimate of Mar 1, 2025 to Mar 4, 2025v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06772181
Lead Sponsor University of Washington
Conditions
(from sponsor)		 Breast Carcinoma
Related terms Breast Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov