Presenter(s)
M. Patel1, E. P. Connolly1, J. C. Choi1, Z. Ghiassi-Nejad1, K. M. Daniell1, D. Grew2, and L. M. Katz3; 1Department of Radiation Oncology, Columbia University Irving Medical Center, New York, NY, 2Saint Francis Hospital and Medical Center, Hartford, CT, 3Department of Radiation Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL
Purpose/Objective(s): A critical yet under-recognized component of breast cancer survivorship is the prevention and management of chronic breast cancer-related lymphedema (BCRL) and upper extremity disability (UED), each with substantial long-term ramifications to physical, social, and psychological well-being. Existing educational materials are often complex, inefficient, and with limited readability. A video-based, asynchronous learning tool may improve access for patients with varying literacy levels and preferred languages, and enhance repeatability/shareability, efficiency, and patient satisfaction. We present a phase II single-arm clinical trial with the primary aim to assess the feasibility of introduction of three educational videos (via PRIMR web platform) to breast cancer patients. Secondary objectives include evaluation of educational, instructional, and motivational efficacy, as well as patient satisfaction scores.
Materials/Methods:
Planned participation duration for this phase II trial is 24 months, with target accrual of 50 patients (25/year) within radiation oncology clinics at a major academic institution and affiliated community satellites. Videos 1/2 (BCRL signs, prevention, management) will be introduced at consultation, first/final fraction, and 1-month/6-month follow-up. Video 3 (institutional resources) will be introduced at first fraction and onwards. Key inclusion criteria are =18 years, ECOG =2, pathologically confirmed breast cancer or non-invasive breast disease, and those who have undergone lumpectomy or mastectomy (with no lymph node sampling, sentinel lymph node biopsy, or axillary lymph node dissection) with plan for adjuvant radiotherapy to the partial breast, whole breast, or chest wall, +/- regional lymphatics. Key exclusion criteria include prior history of BCRL/UED or primary language other than English or Spanish. Primary feasibility endpoints include frequency of video viewing, percentage of videos viewed, and time interval between video views. Secondary endpoints include change in pre- vs post-knowledge scores (educational efficacy), frequency of UE exercises per week (instructional efficacy), number of compression sleeve prescriptions, outpatient PT referrals, and self-reported patient research about lymphedema (motivational efficacy), in addition to patient satisfaction scores. This phase II single-arm clinical trial is with a targeted completion enrollment date of 1/2027. Institutional IRB: AAAV7660.Results: TBD
Conclusion: TBD