Use of Patient-Reported Outcomes Version of CTCAE in Rectal Cancer Trial

Key Points

  • Overall compliance with reporting of the PRO-CTCAE during preoperative therapy was 92.0%.
  • Overall compliance at the 6-month follow-up was 71.2%.

As reported in the Journal of Clinical Oncology, Basch et al established the feasibility of using the National Cancer Institute patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in the setting of a multicenter clinical trial in locally advanced rectal cancer.   

Study Details

The study involved patients enrolled in the National Clinical Trials Network phase II/III North Central Cancer Treatment Group N1048 (Preoperative Radiation or Selective Preoperative Radiation and Evaluation before Chemotherapy and Total Mesorectal Excision [PROSPECT]) trial. Patients in the trial were randomized to two treatment groups. One received 5.5 weeks of radiation with chemotherapy (fluorouracil [5-F] or capecitabine) followed by surgical excision and postoperative chemotherapy. The other received 12 weeks of preoperative chemotherapy (5-FU, leucovorin, and oxaliplatin); those with tumor regression ≥ 20% had surgical excision followed by adjuvant chemotherapy, with the remaining patients receiving chemoradiation, excision, and postoperative chemotherapy, as in the first group.

Patients were requested to self-report 30 PRO-CTCAE items weekly from home during preoperative therapy and then every 6 months after surgery via either the Web or an automated telephone system. During the preoperative period, participants not self-reporting within 3 days of scheduled reporting were called by a central coordinator to complete the items. During the postoperative period, the coordinator initially had up to 1 month to complete data collection; this period was increased to 3 months when a lower-than-expected compliance rate was observed among the first 306 patients.

Compliance With Reporting

A prespecified analysis was conducted after the 500th patient from 165 study sites completed 6-month follow-up. The median age of patients was 56 years, 67% were male, 88% were white, 43% had at most a high school education, and 5% were Spanish-speaking.

The PRO-CTCAE survey was reported by patients at 4,491 of 4,882 expected preoperative time points, yielding 92.0% compliance; 3,771 surveys (77.2%) were self-reported by patients and 720 (14.7%) were obtained by a central coordinator. The 720 reports obtained by the central coordinator represented 64.8% of the total of 1,111 surveys that patients did not complete. At 6 months after surgery, 333 of 468 patients still alive and on study provided reports, yielding 71.2% compliance; 211 patients (45.1%) self-reported and 122 (26.1%) had reports completed by the central coordinator. Study site research associates spent a median of 15 minutes on work related to PRO-CTCAE at each patient site visit. The work performed by a central coordinator required 50% of full-time commitment.

The investigators concluded, “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.”

The study was supported by grants from the National Cancer Institute.

Ethan Basch, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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