Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048

Abstract

Purpose The US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to enable patient reporting of symptomatic adverse events in oncology clinical research. This study was designed to assess the feasibility and resource requirements associated with implementing PRO-CTCAE in a multicenter trial. Methods Patients with locally advanced rectal cancer enrolled in the National Cancer Institute-sponsored North Central Cancer Treatment Group (Alliance) Preoperative Radiation or Selective Preoperative Radiation and Evaluation before Chemotherapy and Total Mesorectal Excision trial were asked to self-report 30 PRO-CTCAE items weekly from home during preoperative therapy, and every 6 months after surgery, via either the Web or an automated telephone system. If participants did not self-report within 3 days, a central coordinator called them to complete the items. Compliance was defined as the proportion of participants who completed PRO-CTCAE assessments at expected time points. Results The prespecified PRO-CTCAE analysis was conducted after the 500th patient completed the 6-month follow-up (median age, 56 years; 33% female; 12% nonwhite; 43% high school education or less; 5% Spanish speaking), across 165 sites. PRO-CTCAE was reported by participants at 4,491 of 4,882 expected preoperative time points (92.0% compliance), of which 3,771 (77.2%) were self-reported by participants and 720 (14.7%) were collected via central coordinator backup. Compliance at 6-month post-treatment follow-up was 333 of 468 (71.2%), with 122 (26.1%) via backup. Site research associates spent a median of 15 minutes on PRO-CTCAE work for each patient visit. Work by a central coordinator required a 50% time commitment. Conclusion Home-based reporting of PRO-CTCAE in a multicenter trial is feasible, with high patient compliance and low site administrative requirements. PRO-CTCAE data capture is improved through centralized backup calls.

Figures

Fig 1.

Proportion of participants completing the expected Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey at baseline, and at each week of preoperative therapy, and at 6-month post-treatment follow-up. Postop, Postoperative.

Fig 2.

Proportion of participants competing various proportions of expected Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys during treatment (N = 500). Two thirds of patients (337 of 500) completed all expected surveys, whereas 90% (450 of 500) completed > 70% of expected surveys, and only two completed no expected surveys.

Fig A1.

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) compliance rates by week for subset of patients selecting Web reporting (n = 316). Postop, Postoperative.

Fig A2.

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) compliance rates by week for subset of patients selecting automated telephone reporting (n = 184). Postop, Postoperative.