W. Sperduto1, M. M. Voss2, B. Laughlin1, M. R. Buras3, M. R. Waddle4, L. A. Vallow5, and C. E. Vargas1; 1Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ, 2Department of Quantitative Health Sciences, Mayo Clinic, Phoenix, AZ, 3Department of Qualitative Health Sciences, Section of Biostatistics, Mayo Clinic, Scottsdale, AZ, 4Department of Radiation Oncology, Mayo Clinic, Rochester, MN, 5Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL
Purpose/Objective(s): To report the results of our prospective study on electronic patient-reported outcome (ePRO) monitoring-aided management of patients with breast cancer (BC) receiving hypofractionated adjuvant radiation therapy (RT). Materials/
Methods: Between August 17, 2022, and October 4, 2023, 23 patients with localized BC were consented and enrolled. Patients received ePRO questionnaires across 6 domains (overall health, financial burden, education/communication of disease process, cosmesis, functional outcome, treatment-related toxicity) – a minimum of 12 questions if no adverse events (AEs) and a maximum of 31 questions if AEs were found in all domains. Suggested interventions were sent back to the patient and care team based on patient responses; questionnaires were sent pre-RT, at the end of treatment (EOT), and before 3-month (3m) follow-up. The primary analysis was conducted using a one-sided 1-sample proportion test with Yates continuity correction based on the 3m response rate of 50% as baseline. A correlation coefficient of 0.3-0.5 was considered low positive; 0.5-0.7 moderate positive; 0.7-0.9 high positive; >0.9 very high positive. Results: All patients were treated with 3D conformal image-guided radiation to a dose of 25 or 40 Gy in 5 or 15 fractions, respectively. All patients rated their well-being as good/excellent and reported being fully active or experiencing restrictions only in strenuous activities. Financial hardship of moderate or worse severity was not reported in any cases; 60% reported no hardship, while the remainder reported mild hardship but with expenses covered and maintaining daily living expenses unchanged. Patient-reported cosmesis was rated as good/excellent in 90% at baseline and 86% at 3m follow-up. Minimal radiation changes were reported by 8.3% pre-RT, 36% at EOT, and 19% at 3m of patients while Grade 1 skin dermatitis reported by physicians was found in 0% pre-RT, 90% at EOT, and 8% at 3m (correlation 0.41). Mild breast swelling was reported by 42% pre-RT, 57% at EOT, and 56% at 3m, while physician-reported Grade 1 breast lymphedema was observed in 5% pre-RT, 0% at EOT, and 17% at 3m (correlation 0.49). One case of breast infection was reported by both patients and physicians at 3m. Minimal breast pain was reported by 17% of patients pre-RT, 29% at EOT, and 63% at 3m, while physicians reported only breast pain in 12.5% at 3m (correlation 0.31). Mild functional impairment was observed in 1 patient at baseline and 2 patients at 3m. Electronic PROs monitoring increased patient response rates to 69% (p=0.047), showing high discrimination for moderate/severe/very severe PROs and Grade 2 or higher AEs. However, PROs were more sensitive in reporting none to mild events. Grade 1 AE rates at baseline, at EOT, and at 3m were 21.7%, 47.8%, and 56.5%, respectively. Conclusion: Electronic PROs monitoring increased patient reporting and provided useful clinical information to aid management. Patients reported higher rates of mild AEs than physicians.
