Basch E, et al. - Whether the implementation of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) developed by the US National Cancer Institute (NCI) to enable patient reporting of symptomatic adverse events in oncology clinical research in a multicenter trial is feasible was investigated, as well as the resource requirements associated with its implementation. Findings suggested the feasibility of home-based reporting of PRO-CTCAE in a multicenter trial, with high patient compliance and low site administrative requirements. Centralized backup calls improved PRO-CTCAE data capture.

Methods

• 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, enrolled patients with locally advanced rectal cancer were asked to self-report 30 PRO-CTCAE items weekly from home during preoperative therapy, and every 6 months after surgery, through either the Web or an automated telephone system.
• A central coordinator called the participants to complete the items in case participants failed to self-report within 3 days.
• The percentage of participants who completed PRO-CTCAE assessments at expected time points defined compliance.

Results

• Following the completion of the 6-month follow-up by the 500th patient (median age, 56 years; 33% female; 12% nonwhite; 43% high school education or less; 5% Spanish speaking), the prespecified PRO-CTCAE analysis was carried out across 165 sites.
• Findings revealed that, participants reported PRO-CTCAE at 4,491 of 4,882 expected preoperative time points (92.0% compliance); 3,771 (77.2%) of those were self-reported by participants and 720 (14.7%) were obtained through central coordinator backup.
• At 6-month post-treatment follow-up, the observed compliance was 333 of 468 (71.2%), with 122 (26.1%) via central coordinator backup.
• For each patient visit, a median of 15 minutes was spent by site research associates on PRO-CTCAE work.
• A 50% time commitment was needed for work by a central coordinator.