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.
Additional locations may be listed on ClinicalTrials.gov for NCT06772181.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Erin F. Gillespie
Phone: 206-598-4100
Spokane Valley
MultiCare Deaconess Cancer and Blood Specialty Center - ValleyStatus: Active
Contact: Zachary Guss
Phone: 509-228-1000
PRIMARY OBJECTIVES:
I. Acceptability of using digital strategies for patient-reported outcomes (PRO) screening and/or intervention (IM@Home) among patients undergoing breast radiation treatment in a socioeconomically diverse community clinic.
II. Feasibility and appropriateness of the IM@Home program among patients undergoing breast radiation in a socioeconomically diverse community clinic.
SECONDARY OBJECTIVES:
I. Fatigue.
II. Physical Activity.
III. Insomnia.
EXPLORATORY OBJECTIVES:
I. Social Isolation.
II. Burden of Care.
III. Sociodemographic barriers to care.
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 may participate in the IM@Home program consisting of 20+ live, virtual mind-body and cardio 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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorErin F. Gillespie
