Engaging survivor and oncologist stakeholders to develop a patient-reported outcome assessment to use as a component of survivorship care

Purpose Incorporating patient-reported outcomes (PROs) into survivorship care may improve the comprehensiveness of follow-up. The objective was to engage stakeholders to develop a PRO assessment of survivors’ symptoms and concerns for use during breast cancer follow-up. Methods We convened patient and oncologist stakeholder advisory groups to develop an initial PRO assessment including survivorship domains of importance, measurement instruments, and clinically significant thresholds, and revise the assessment based on feedback from community focus groups and two rounds of iterative pilot testing with survivors. Results Stakeholders identified key domains and measurement instruments, including recurrence symptoms, treatment side effects, adherence, mental health, and sexual health. Ninety-four survivors completed the PRO assessment in the initial pilot test (median age 62 years, median 2 years from diagnosis). Most (89/93) reported questions were easy to understand. The level of missingness was low. The most common threshold-level symptoms/concerns were hot flashes (46%), fatigue (35%), back pain (31%), joint pain (31%), and anxiety (30%). The PRO assessment was revised to clarify symptom causality and desire to discuss with a provider. In a follow-up pilot study with 20 survivors, the most common symptoms were chest/breast discomfort (50%) and anxiety (25%). Conclusions We leveraged stakeholder input to develop a comprehensive PRO assessment to use to assess breast cancer survivors’ well-being. Our PRO assessment is acceptable to survivors. Future research will focus on the integration of the PRO assessment into clinical care.