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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.

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Basch, E; Pugh, SL; Dueck, AC; Mitchell, SA; Berk, L; Fogh, S; Rogak, LJ; Gatewood, M; Reeve, BB; Mendoza, TR; O'Mara, AM; Denicoff, AM ...
Published in: Int J Radiat Oncol Biol Phys
June 1, 2017

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 NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after 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 RTOG 1012, 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 RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance 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 AEs 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 using central compliance monitoring. These approaches are being incorporated into ongoing studies.

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Published In

Int J Radiat Oncol Biol Phys

DOI

EISSN

1879-355X

Publication Date

June 1, 2017

Volume

98

Issue

2

Start / End Page

409 / 418

Location

United States

Related Subject Headings

  • United States
  • Time Factors
  • Symptom Assessment
  • Self Report
  • Patient Reported Outcome Measures
  • Patient Compliance
  • Pain
  • Oncology & Carcinogenesis
  • National Cancer Institute (U.S.)
  • Middle Aged
 

Citation

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Basch, E., Pugh, S. L., Dueck, A. C., Mitchell, S. A., Berk, L., Fogh, S., … Bruner, D. W. (2017). 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. In Int J Radiat Oncol Biol Phys (Vol. 98, pp. 409–418). United States. https://doi.org/10.1016/j.ijrobp.2017.02.002
Basch, Ethan, Stephanie L. Pugh, Amylou C. Dueck, Sandra A. Mitchell, Lawrence Berk, Shannon Fogh, Lauren J. Rogak, et al. “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.” In Int J Radiat Oncol Biol Phys, 98:409–18, 2017. https://doi.org/10.1016/j.ijrobp.2017.02.002.
Basch E, Pugh SL, Dueck AC, Mitchell SA, Berk L, Fogh S, Rogak LJ, Gatewood M, Reeve BB, Mendoza TR, O’Mara AM, Denicoff AM, Minasian LM, Bennett AV, Setser A, Schrag D, Roof K, Moore JK, Gergel T, Stephans K, Rimner A, DeNittis A, Bruner DW. 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. Int J Radiat Oncol Biol Phys. 2017. p. 409–418.
Journal cover image

Published In

Int J Radiat Oncol Biol Phys

DOI

EISSN

1879-355X

Publication Date

June 1, 2017

Volume

98

Issue

2

Start / End Page

409 / 418

Location

United States

Related Subject Headings

  • United States
  • Time Factors
  • Symptom Assessment
  • Self Report
  • Patient Reported Outcome Measures
  • Patient Compliance
  • Pain
  • Oncology & Carcinogenesis
  • National Cancer Institute (U.S.)
  • Middle Aged