Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

• Type of Material: Article
• Authors: Ethan Basch, Memorial Sloan Kettering Cancer Center; Stephanie L. Pugh, NRG Oncology Statistics & Data Management Center; Amylou C. Dueck, Mayo Clinic; Sandra A. Mitchell, National Cancer Institute; Lawrence Berk, University of South Florida; Shannon Fogh, University of California San Francisco; Lauren J Rogak, Memorial Sloan Kettering Cancer Center; Marcha Gatewood, Emory University; Bryce B Reeve, University of North Carolina; Tito R Mendoza, University Texas MD Anderson Cancer Center; Ann O'Mara, National Cancer Institute; Andrea Denicoff, National Cancer Institute; Lori Minasian, National Cancer Institute; Antonia Bennett, University of North Carolina; Ann Setser, Setser Health Consulting LLC; Deborah Schrag, Dana Farber Cancer Institute; Kevin Roof, NCORP; Joan K Moore, Wellspan Adams Cancer Center; Thomas Gergel, Geisinger Medical Center; Kevin Stephans, Cleveland Clinical Foundation; Andreas Rimner, Memorial Sloan Kettering Cancer Center; Albert DeNittis, Main Line CCOP; Deborah W. Bruner, Emory University
• Language: English
• Date: 2017-06-01
• Publisher: Elsevier
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2017 Elsevier Inc.
• Final Published Version (URL): http://dx.doi.org/10.1016/j.ijrobp.2017.02.002
• Title of Journal or Parent Work: International Journal of Radiation Oncology - Biology - Physics
• ISSN: 0360-3016
• Volume: 98
• Issue: 2
• Start Page: 409
• End Page: 418
• Grant/Funding Information: This project was supported by grants U10CA180822, U10CA180868, U10CA21661, U10CA37422, HHSN261200800043C, and HHSN261201000063C from the National Cancer Institute (NCI).
• Keywords: CELL LUNG-CANCER; Life Sciences & Biomedicine; RELIABILITY; QUALITY-OF-LIFE; Oncology; Science & Technology; CHEMOTHERAPY; Radiology, Nuclear Medicine & Medical Imaging
• Research Categories: Biology, Biostatistics; Health Sciences, Oncology

Abstract

Purpose To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between visits, and by using central compliance monitoring. These approaches are being incorporated into ongoing studies.