Feasibility of implementing the patient-reported outcomes version of the common terminology criteria for adverse events in a multicenter trial: NCCTG N1048

Ethan Basch, Amylou Dueck, Lauren J. Rogak, Sandra A. Mitchell, Lori M. Minasian, Andrea M. Denicoff, Jennifer K. Wind, Mary C. Shaw, Narre Heon, Qian D Shi, Brenda Ginos, Garth D. Nelson, Jeffrey P. Meyers, George J. Chang, Harvey J. Mamon, Martin R. Weiser, Tatjana Kolevska, Bryce B. Reeve, Deborah Watkins Bruner, Deborah Schrag

Research output: Contribution to journalArticle

6 Citations (Scopus)

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 selfreported 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.

Original languageEnglish (US)
Pages (from-to)3120-3125
Number of pages6
JournalJournal of Clinical Oncology
Volume36
Issue number31
DOIs
StatePublished - Nov 1 2018

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Terminology
Multicenter Studies
Compliance
National Cancer Institute (U.S.)
Self Report
Radiation
Patient Reported Outcome Measures
Medical Oncology
Rectal Neoplasms
Patient Compliance
Research
Telephone
Therapeutics
Education
Drug Therapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Feasibility of implementing the patient-reported outcomes version of the common terminology criteria for adverse events in a multicenter trial : NCCTG N1048. / Basch, Ethan; Dueck, Amylou; Rogak, Lauren J.; Mitchell, Sandra A.; Minasian, Lori M.; Denicoff, Andrea M.; Wind, Jennifer K.; Shaw, Mary C.; Heon, Narre; Shi, Qian D; Ginos, Brenda; Nelson, Garth D.; Meyers, Jeffrey P.; Chang, George J.; Mamon, Harvey J.; Weiser, Martin R.; Kolevska, Tatjana; Reeve, Bryce B.; Bruner, Deborah Watkins; Schrag, Deborah.

In: Journal of Clinical Oncology, Vol. 36, No. 31, 01.11.2018, p. 3120-3125.

Research output: Contribution to journalArticle

Basch, E, Dueck, A, Rogak, LJ, Mitchell, SA, Minasian, LM, Denicoff, AM, Wind, JK, Shaw, MC, Heon, N, Shi, QD, Ginos, B, Nelson, GD, Meyers, JP, Chang, GJ, Mamon, HJ, Weiser, MR, Kolevska, T, Reeve, BB, Bruner, DW & Schrag, D 2018, 'Feasibility of implementing the patient-reported outcomes version of the common terminology criteria for adverse events in a multicenter trial: NCCTG N1048', Journal of Clinical Oncology, vol. 36, no. 31, pp. 3120-3125. https://doi.org/10.1200/JCO.2018.78.8620
Basch, Ethan ; Dueck, Amylou ; Rogak, Lauren J. ; Mitchell, Sandra A. ; Minasian, Lori M. ; Denicoff, Andrea M. ; Wind, Jennifer K. ; Shaw, Mary C. ; Heon, Narre ; Shi, Qian D ; Ginos, Brenda ; Nelson, Garth D. ; Meyers, Jeffrey P. ; Chang, George J. ; Mamon, Harvey J. ; Weiser, Martin R. ; Kolevska, Tatjana ; Reeve, Bryce B. ; Bruner, Deborah Watkins ; Schrag, Deborah. / Feasibility of implementing the patient-reported outcomes version of the common terminology criteria for adverse events in a multicenter trial : NCCTG N1048. In: Journal of Clinical Oncology. 2018 ; Vol. 36, No. 31. pp. 3120-3125.
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title = "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 selfreported 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.",
author = "Ethan Basch and Amylou Dueck and Rogak, {Lauren J.} and Mitchell, {Sandra A.} and Minasian, {Lori M.} and Denicoff, {Andrea M.} and Wind, {Jennifer K.} and Shaw, {Mary C.} and Narre Heon and Shi, {Qian D} and Brenda Ginos and Nelson, {Garth D.} and Meyers, {Jeffrey P.} and Chang, {George J.} and Mamon, {Harvey J.} and Weiser, {Martin R.} and Tatjana Kolevska and Reeve, {Bryce B.} and Bruner, {Deborah Watkins} and Deborah Schrag",
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TY - JOUR

T1 - Feasibility of implementing the patient-reported outcomes version of the common terminology criteria for adverse events in a multicenter trial

T2 - NCCTG N1048

AU - Basch, Ethan

AU - Dueck, Amylou

AU - Rogak, Lauren J.

AU - Mitchell, Sandra A.

AU - Minasian, Lori M.

AU - Denicoff, Andrea M.

AU - Wind, Jennifer K.

AU - Shaw, Mary C.

AU - Heon, Narre

AU - Shi, Qian D

AU - Ginos, Brenda

AU - Nelson, Garth D.

AU - Meyers, Jeffrey P.

AU - Chang, George J.

AU - Mamon, Harvey J.

AU - Weiser, Martin R.

AU - Kolevska, Tatjana

AU - Reeve, Bryce B.

AU - Bruner, Deborah Watkins

AU - Schrag, Deborah

PY - 2018/11/1

Y1 - 2018/11/1

N2 - 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 selfreported 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.

AB - 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 selfreported 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.

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