Feasibility of Patient Reporting of Symptomatic Adverse Events via the PRO-CTCAE in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

Publication date: Available online 10 February 2017
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Ethan Basch, Stephanie L. Pugh, Amylou C. Dueck, Sandra A. Mitchell, Lawrence Berk, Shannon Fogh, Lauren J. Rogak, Marcha Gatewood, Bryce B. Reeve, Tito R. Mendoza, Ann O'Mara, Andrea Denicoff, Lori Minasian, Antonia V. Bennett, Ann Setser, Deborah Schrag, Kevin Roof, Joan K. Moore, Thomas Gergel, Kevin Stephans, Andreas Rimner, Albert DeNittis, Deborah Watkins Bruner
PurposeTo 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 MaterialsPatients enrolled in Trial XXXX (XXXX) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly x4 during treatment; 12-weeks post-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.ResultsAmong 226 study sites participating in Trial XXXX, 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 Trial XXXX agreed to self-report using the PRO-CTCAE (median age 66; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range 30-240), and median time for CRAs to teach a patient to self-report was 10 minutes (range 2-60). Compliance was high, particularly during active treatment when patients self-reported at 86% of expected time points, although compliance was lower post-treatment (72%). Common reasons for non-compliance were institutional errors such as forgetting to provide computers to participants; patients missing clinic visits; internet connectivity; and patients feeling "too sick".ConclusionsMost patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic adverse events 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 employing central compliance monitoring. These approaches are being incorporated into ongoing studies.

Teaser

The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed by the National Cancer Institute to enable patient-reporting of toxicities in clinical research. To assess feasibility of implementation, PRO-CTCAE was integrated into an NRG Oncology trial. During treatment, patients reported via tablet computers at 86% of visits. Reasons for missing reports included staff errors, missed appointments, and internet connectivity. Strategies to address these reasons are being assessed in ongoing studies.


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