Core C: Patient-Reported Outcomes & Function (PROF)

ABSTRACT: CORE C (PROF) Based on over 8 years of successful longitudinal, prospective patient-centered outcomes data collection in oropharynx cancer (OPC) survivors supporting data use for over 20 investigators from multi-disciplinary backgrounds, the Patient-Reported Outcomes/Function (PROF) Core is a comprehensive infrastructure for patient-reported outcome (PRO) data alongside validated clinician-graded outcomes (CRO) and chart abstracted metrics of adverse sequelae for the MD Anderson OPC Cohort for the OPC-SURVIVOR P01 Program portfolio. Since 2015, we developed and implemented procedures to collect PRO and clinician-rated adverse effects from diagnosis through five years of survivorship. We will extend assessments of OPC survivors beyond five years and integrate Project-specific PROF data elements as a critical resource for all Projects in the OPC-SURVIVOR Program. We will work alongside all Project Investigators and Core Leads toward development and validation of clinic-ready measures and markers of delayed adverse sequelae. Precise outcome measurement in OPC survivorship is critical to characterize and mitigate adverse treatment sequelae as key drivers of quality of life and functional status. We will accomplish our mission through these objectives: 1. To provide patient-facing MD Anderson OPC (MDA-OPC) cohort operations namely recruitment and retention of human subjects for longitudinal, serial primary data collection and data management of PRO and CRO markers of adverse sequelae. 2. To employ rigorous methods for data fidelity and timeline adherence. This includes infrastructure to monitor and visualize metrics, and regular quality checks of PRO, CRO, and Project-specific data elements. 3. To maintain optimal data management infrastructure for data transmission in collaboration with all Cores. 4. To develop and integrate novel validated outcome measures into the PROF Core to measure and track cranial neuropathies, mandibular osteoradionecrosis and late radiation-associated dysphagia. 5. To collaborate with the Clinical Informatics/Analysis Core to sustain and optimize a comprehensive and integrated Web-based database management system to facilitate prospective data collection, entry, quality control, integration, query, reporting, dashboards and data visualization of data for all Projects. 6. To employ patient-centered, user-friendly data capture methods to minimize patient burden, enhance study retention and optimize Project outcomes collection. 7. To integrate new longitudinal data elements from Program Projects into existing data infrastructure. 9. To support the development of innovative longitudinal data analysis methods and machine learning models that efficiently use all available elements in the database of the MDA-OPC cohort. 10. To capture rare symptoms while reducing patient burden through development of an enhanced, individualized feedback PRO tool.