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

Ethan Basch, Stephanie L. Pugh, Amylou Dueck, Sandra A. Mitchell, Lawrence Berk, Shannon Fogh, Lauren J. Rogak, Marcha Gatewood, Bryce B. Reeve, Tito R. Mendoza, Ann M. O'Mara, Andrea M. Denicoff, Lori M. Minasian, Antonia V. Bennett, Ann Setser, Deborah Schrag, Kevin Roof, Joan K. Moore, Thomas Gergel, Kevin StephansAndreas Rimner, Albert DeNittis, Deborah Watkins Bruner

Research output: Contribution to journalArticle

23 Citations (Scopus)

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 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.

Original languageEnglish (US)
Pages (from-to)409-418
Number of pages10
JournalInternational Journal of Radiation Oncology Biology Physics
Volume98
Issue number2
DOIs
StatePublished - Jun 1 2017

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terminology
Chemoradiotherapy
Terminology
Multicenter Studies
Clinical Trials
Self Report
Handheld Computers
Compliance
tablets
Research
Therapeutics
Patient Reported Outcome Measures
Honey
Esophagitis
National Cancer Institute (U.S.)
Ambulatory Care
cancer
Internet
Lung Neoplasms
sensory feedback

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

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. / Basch, Ethan; Pugh, Stephanie L.; Dueck, Amylou; Mitchell, Sandra A.; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J.; Gatewood, Marcha; Reeve, Bryce B.; Mendoza, Tito R.; O'Mara, Ann M.; Denicoff, Andrea M.; Minasian, Lori M.; Bennett, Antonia V.; Setser, Ann; Schrag, Deborah; Roof, Kevin; Moore, Joan K.; Gergel, Thomas; Stephans, Kevin; Rimner, Andreas; DeNittis, Albert; Bruner, Deborah Watkins.

In: International Journal of Radiation Oncology Biology Physics, Vol. 98, No. 2, 01.06.2017, p. 409-418.

Research output: Contribution to journalArticle

Basch, E, Pugh, SL, Dueck, A, 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 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', International Journal of Radiation Oncology Biology Physics, vol. 98, no. 2, pp. 409-418. https://doi.org/10.1016/j.ijrobp.2017.02.002
Basch, Ethan ; Pugh, Stephanie L. ; Dueck, Amylou ; Mitchell, Sandra A. ; Berk, Lawrence ; Fogh, Shannon ; Rogak, Lauren J. ; Gatewood, Marcha ; Reeve, Bryce B. ; Mendoza, Tito R. ; O'Mara, Ann M. ; Denicoff, Andrea M. ; Minasian, Lori M. ; Bennett, Antonia V. ; Setser, Ann ; Schrag, Deborah ; Roof, Kevin ; Moore, Joan K. ; Gergel, Thomas ; Stephans, Kevin ; Rimner, Andreas ; DeNittis, Albert ; Bruner, Deborah Watkins. / 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: International Journal of Radiation Oncology Biology Physics. 2017 ; Vol. 98, No. 2. pp. 409-418.
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title = "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 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.",
author = "Ethan Basch and Pugh, {Stephanie L.} and Amylou Dueck and Mitchell, {Sandra A.} and Lawrence Berk and Shannon Fogh and Rogak, {Lauren J.} and Marcha Gatewood and Reeve, {Bryce B.} and Mendoza, {Tito R.} and O'Mara, {Ann M.} and Denicoff, {Andrea M.} and Minasian, {Lori M.} and Bennett, {Antonia V.} and Ann Setser and Deborah Schrag and Kevin Roof and Moore, {Joan K.} and Thomas Gergel and Kevin Stephans and Andreas Rimner and Albert DeNittis and Bruner, {Deborah Watkins}",
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T1 - 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

AU - Basch, Ethan

AU - Pugh, Stephanie L.

AU - Dueck, Amylou

AU - Mitchell, Sandra A.

AU - Berk, Lawrence

AU - Fogh, Shannon

AU - Rogak, Lauren J.

AU - Gatewood, Marcha

AU - Reeve, Bryce B.

AU - Mendoza, Tito R.

AU - O'Mara, Ann M.

AU - Denicoff, Andrea M.

AU - Minasian, Lori M.

AU - Bennett, Antonia V.

AU - Setser, Ann

AU - Schrag, Deborah

AU - Roof, Kevin

AU - Moore, Joan K.

AU - Gergel, Thomas

AU - Stephans, Kevin

AU - Rimner, Andreas

AU - DeNittis, Albert

AU - Bruner, Deborah Watkins

PY - 2017/6/1

Y1 - 2017/6/1

N2 - 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.

AB - 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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