Capturing breast cancer patients' experience beyond disease progression: Implementation of a patient-reported outcome (PRO) substudy in the VIRGO Metastatic Breast Cancer Observational Cohort study.

Abstract

6138 Background: Patient-reported outcomes (PROs) in clinical trials provide insight into the Pt experience but are often limited to the time the Pt is undergoing therapy, since PRO collection typically stops when Pts progress. In an OCS, Pts are observed in a real world setting and followed longitudinally through the course of their disease. To assess the impact of disease progression (PD) on PROs, we have initiated a PRO substudy in VIRGO, a MBC disease OCS. Methods: A literature review was performed to assess potential PRO instruments for study inclusion. Cognitive debriefings were conducted with 10 MBC Pts to assess acceptability, length, frequency, and preferred mode of administration for these instruments. Results: The following instruments were selected: MD Anderson Symptom Inventory (MDASI), the Activity Level Scale (ALS) from the Rotterdam Symptom Checklist, and the Work Productivity and Activity Impairment Questionnaire (WPAI). Participants in the cognitive debriefing completed these instruments in 10-30 minutes, 100% reported this duration to be appropriate in length, 80% stated that monthly frequency was reasonable, and 70% preferred internet as mode of administration. Based on these findings, PRO substudy data are collected monthly for MDASI and ALS, and quarterly for the WPAI until death, study discontinuation, or 5 years of follow up. PRO data collection via a secure internet-based website or IVRS began on 9/14/2009. As of 1/5/2010, 65 Pts have enrolled in the PRO substudy. 63% of Pts provided data through the internet, and 29% through IVRS; 8% are unknown due to new enrollment. Conclusions: VIRGO is currently the largest prospective OCS in MBC. The implementation of the PRO substudy demonstrates that PRO collection is viable in a large OCS. The PRO substudy will be a valuable longitudinal dataset of patient-reported symptoms, activities of daily living, and work productivity. These data will provide a unique understanding of MBC Pts long-term experience through the course of their disease and the relationship between PROs and disease progression. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech Genentech Roche Genentech, Outcome Sciences, Inc.