Digital health program to enhance activity and reduce symptoms in breast cancer patients during radiation
Multicenter Pilot Study: Leveraging Digital Health to Promote Evidence-Based Physical Activity to Improve Symptoms Among Patients Undergoing Radiation for Breast Cancer (PRO-ACTIVE)
This study is testing a digital health program that gives breast cancer patients a FitBit and offers online classes like yoga and meditation to help them feel better and be more active during radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Seattle, Washington and 1 other locations) |
| Trial ID | NCT06772181 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a digital health intervention aimed at improving symptoms and increasing physical activity in breast cancer patients undergoing radiation therapy. Participants receive a FitBit to track their activity and complete surveys to monitor fatigue and other symptoms. Those reporting issues are invited to join the Integrative Medicine at Home (IM@Home) program, which includes live virtual classes such as yoga, tai chi, and guided meditation. The program encourages patients to engage in at least three classes per week over a 12-week period to help manage their symptoms and improve their quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are currently diagnosed with breast cancer and receiving radiation therapy.
Not a fit: Patients with metastatic breast cancer (stage IV) will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for breast cancer patients by reducing fatigue and improving physical activity levels during treatment.
How similar studies have performed: Other studies have shown success with similar mind-body interventions in managing cancer-related symptoms, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seattle, Washington and 1 other locations
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
- MultiCare Valley Hospital (Spokane) — Spokane Valley, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Erin Gillespie, MD, MPH — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Erin Gillespie, MD, MPH
- Email: efgillespie@ucsd.edu
- Phone: 206-598-4100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.