Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators.

AIM: To develop a comprehensive item library of patient-reported, immunotherapy-related adverse events (irAEs) that draws from and expands on the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. METHODS: Literature review and iterative expert input. Based on a literature review of irAEs, we developed a framework of immunotherapy classes and their associated symptoms. Clinical experts then reviewed iterations of symptom summaries and item maps linked to the immunotherapy framework. Experts provided content review and feedback was shared across experts until consensus was reached. The iterative process facilitated creation of a Primary Symptom List associated with immune checkpoint modulators (ICMs), drawn from the larger set of symptoms. Existing FACIT items were mapped to the symptom list, and new items were written as needed to create the item library. RESULTS: The full item library of irAEs is comprised of 239 items, covering 142 unique symptoms across 75 inflammatory reactions/immune conditions. A subset of 66 items comprises a Primary Symptom List considered most common/relevant to ICM treatment. This includes gastrointestinal, skin, pulmonary, neurologic, musculoskeletal, and multiple miscellaneous and constitutional symptoms. CONCLUSION: The FACIT Immunotherapy Item Library is a compilation of 239 self-report items that capture the wide range of AEs experienced by people receiving immune treatments. A subset of 66 items comprises a Primary Symptom List meant for ICM therapy. Use of items selected from this library is encouraged in clinical research and clinical practice evaluation.

Development of an eHealth System to Capture and Analyze Patient Sensor and Self-Report Data: Mixed-Methods Assessment of Potential Applications to Improve Cancer Care Delivery.

BACKGROUND: Capturing and Analyzing Sensor and Self-Report Data for Clinicians and Researchers (COMPASS) is an electronic health (eHealth) platform designed to improve cancer care delivery through passive monitoring of patients' health status and delivering customizable reports to clinicians. Based on data from sensors and context-driven administration of patient-reported outcome (PRO) measures, key indices of patients' functional status can be collected between regular clinic visits, supporting clinicians in the delivery of patient care. OBJECTIVE: The first phase of this project aimed to systematically collect input from oncology providers and patients on potential clinical applications for COMPASS to refine the system. METHODS: Ten clinicians representing various oncology specialties and disciplines completed semi-structured interviews designed to solicit clinician input on how COMPASS can best support clinical care delivery. Three cancer patients tested a prototype of COMPASS for 7 days and provided feedback. Interview data were tabulated using thematic content analysis to identify the most clinically relevant objective and PRO domains. RESULTS: Thematic content analysis revealed that clinicians were most interested in monitoring vital statistics, symptoms, and functional status, including the physical activity level (n=9), weight (n=5), fatigue (n=9), sleep quality (n=8), and anxiety (n=7). Patients (2 in active treatment and 1 in remission) reported that they would use such a device, were enthusiastic about their clinicians monitoring their health status, especially the tracking of symptoms, and felt knowing their clinicians were monitoring and reviewing their health status provided valuable reassurance. Patients would, however, like to provide some context to their data. CONCLUSIONS: Clinicians and patients both articulated potential benefits of the COMPASS system in improving cancer care. From a clinician standpoint, data need to be easily interpretable and actionable. The fact that patients and clinicians both see potential value in eHealth systems suggests wider adoption and utilization could prove to be a useful tool for improving care delivery.

Square Pegs, Round Hole? Ensuring Fit in the AYAO Spectrum for Adolescents and Young Adults with Genetic Risk for Cancer.

This paper presents a case example of a young woman at genetic risk for future cancer. We discuss psychosocial challenges that adolescents and young adults (AYAs) may share with their cancer survivor peers, and describe an example of psychosocial care. A scientific foundation denoting the needs of AYAs at risk for heritable cancers is lacking, and it is unknown if these AYAs receive adequate support services. This is a call to action for practitioners and researchers to engage in initiatives that assure these AYAs have access to valuable support and more clearly mark their place within the spectrum of AYA oncology.