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

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 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. Results Among 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”. Conclusions Most 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.

ESMO–ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease

“…Recently, Basch et al 304 showed that self-evaluation of symptoms could significantly improve QoL during treatment, decrease emergency admissions, and even improve survival of patients with advanced cancers. The possible negative impact of treatment on QoL due to AEs should be considered and balanced against the possible positive effects of treatment to reduce or delay cancer symptoms.…”

Patient-Reported Toxicities During Chemotherapy Regimens in Current Clinical Practice for Early Breast Cancer

“…Standardized reporting is now available through the National Cancer Institute's Patient-Reported Outcomes-CTCAE (PRO-CTCAE) scales [10][11][12][13]. Efforts are underway to integrate PRO-CTCAE measurement into clinical trials [14][15][16][17][18][19], and interest is growing in the implementation and utilization of patient-reported symptom monitoring in patient-centered clinical practice [20][21][22][23][24][25][26][27][28][29]. Like CTCAE, the focus of PRO-CTCAE is continuous symptom monitoring throughout chemotherapy, not just at the beginning and end of chemotherapy.…”

Including the patient voice in the development and implementation of patient‐reported outcomes in cancer clinical trials

“…Patient representatives were active participants throughout the development of this measure and a wider group of patients was involved in providing detailed feedback at several points in the process . Basch and colleagues have shown that patients are willing and able to complete the PRO‐CTCAE for the collection of adverse event recording and that minimal additional resources are required . Making the use of a PRO on AEs mandatory may provide a better assessment of the balance between the efficacy and toxicity of cancer treatments …”