PMID- 28463161
OWN - NLM
STAT- MEDLINE
DCOM- 20170726
LR  - 20220317
IS  - 1879-355X (Electronic)
IS  - 0360-3016 (Print)
IS  - 0360-3016 (Linking)
VI  - 98
IP  - 2
DP  - 2017 Jun 1
TI  - 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.
PG  - 409-418
LID - S0360-3016(17)30318-8 [pii]
LID - 10.1016/j.ijrobp.2017.02.002 [doi]
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 x4 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.
CI  - Copyright (c) 2017 Elsevier Inc. All rights reserved.
FAU - Basch, Ethan
AU  - Basch E
AD  - Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer 
      Center, New York, New York; Lineberger Comprehensive Cancer Center, University of 
      North Carolina, Chapel Hill, North Carolina. Electronic address: 
      ebasch@med.unc.edu.
FAU - Pugh, Stephanie L
AU  - Pugh SL
AD  - NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
FAU - Dueck, Amylou C
AU  - Dueck AC
AD  - Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona.
FAU - Mitchell, Sandra A
AU  - Mitchell SA
AD  - Division of Cancer Control and Population Sciences, Outcomes Research Branch, 
      National Cancer Institute, Rockville, Maryland.
FAU - Berk, Lawrence
AU  - Berk L
AD  - Radiation Oncology, University of South Florida, Tampa, Florida.
FAU - Fogh, Shannon
AU  - Fogh S
AD  - Department of Radiation Oncology, University of California, San Francisco, San 
      Francisco, California.
FAU - Rogak, Lauren J
AU  - Rogak LJ
AD  - Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer 
      Center, New York, New York.
FAU - Gatewood, Marcha
AU  - Gatewood M
AD  - Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.
FAU - Reeve, Bryce B
AU  - Reeve BB
AD  - Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel 
      Hill, North Carolina.
FAU - Mendoza, Tito R
AU  - Mendoza TR
AD  - Department of Symptom Research, The University of Texas MD. Anderson Cancer 
      Center, Houston, Texas.
FAU - O'Mara, Ann M
AU  - O'Mara AM
AD  - Division of Cancer Control and Population Sciences, Outcomes Research Branch, 
      National Cancer Institute, Rockville, Maryland.
FAU - Denicoff, Andrea M
AU  - Denicoff AM
AD  - Division of Cancer Control and Population Sciences, Outcomes Research Branch, 
      National Cancer Institute, Rockville, Maryland.
FAU - Minasian, Lori M
AU  - Minasian LM
AD  - Division of Cancer Control and Population Sciences, Outcomes Research Branch, 
      National Cancer Institute, Rockville, Maryland.
FAU - Bennett, Antonia V
AU  - Bennett AV
AD  - Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel 
      Hill, North Carolina.
FAU - Setser, Ann
AU  - Setser A
AD  - Setser Health Consulting, LLC, St. Louis, Missouri.
FAU - Schrag, Deborah
AU  - Schrag D
AD  - Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, 
      Massachusetts.
FAU - Roof, Kevin
AU  - Roof K
AD  - Southeast Radiation Oncology, Southeast Community Cancer Consortium Nation Cancer 
      NCI Community Oncology Research Program (NCORP), Charlotte, North Carolina.
FAU - Moore, Joan K
AU  - Moore JK
AD  - Department of Oncology Administration, Wellspan Adams Cancer Center, York, 
      Pennsylvania.
FAU - Gergel, Thomas
AU  - Gergel T
AD  - Radiation Oncology, Geisinger Medical Center Community Clinical Oncology Program 
      (CCOP), Danville, Pennsylvania.
FAU - Stephans, Kevin
AU  - Stephans K
AD  - Radiation Oncology, Cleveland Clinic Foundation, Cleveland, Ohio.
FAU - Rimner, Andreas
AU  - Rimner A
AD  - Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New 
      York, New York.
FAU - DeNittis, Albert
AU  - DeNittis A
AD  - Radiation Oncology, Main Line CCOP, Wynnewood, Pennsylvania.
FAU - Bruner, Deborah Watkins
AU  - Bruner DW
AD  - Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.
LA  - eng
GR  - U10 CA180868/CA/NCI NIH HHS/United States
GR  - UG1 CA189867/CA/NCI NIH HHS/United States
GR  - P30 CA016086/CA/NCI NIH HHS/United States
GR  - HHSN261200800043C/CA/NCI NIH HHS/United States
GR  - U10 CA037422/CA/NCI NIH HHS/United States
GR  - U10 CA021661/CA/NCI NIH HHS/United States
GR  - U10 CA180822/CA/NCI NIH HHS/United States
GR  - HHSN261201000063C/CA/NCI NIH HHS/United States
GR  - UG1 CA189852/CA/NCI NIH HHS/United States
GR  - U10 CA180867/CA/NCI NIH HHS/United States
GR  - U10 CA180838/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170210
PL  - United States
TA  - Int J Radiat Oncol Biol Phys
JT  - International journal of radiation oncology, biology, physics
JID - 7603616
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Apitherapy/methods
MH  - Chemoradiotherapy/*adverse effects
MH  - Deglutition Disorders/etiology/therapy
MH  - Esophagitis/*complications
MH  - Feasibility Studies
MH  - Female
MH  - Honey
MH  - Humans
MH  - Internet
MH  - Lung Neoplasms/*therapy
MH  - Male
MH  - Microcomputers/*statistics & numerical data
MH  - Middle Aged
MH  - National Cancer Institute (U.S.)
MH  - Pain/*prevention & control
MH  - Patient Compliance/*statistics & numerical data
MH  - *Patient Reported Outcome Measures
MH  - Self Report/*statistics & numerical data
MH  - Symptom Assessment/statistics & numerical data
MH  - Time Factors
MH  - United States
PMC - PMC5557037
MID - NIHMS864539
EDAT- 2017/05/04 06:00
MHDA- 2017/07/27 06:00
PMCR- 2018/06/01
CRDT- 2017/05/03 06:00
PHST- 2016/11/30 00:00 [received]
PHST- 2017/02/02 00:00 [accepted]
PHST- 2017/05/03 06:00 [entrez]
PHST- 2017/05/04 06:00 [pubmed]
PHST- 2017/07/27 06:00 [medline]
PHST- 2018/06/01 00:00 [pmc-release]
AID - S0360-3016(17)30318-8 [pii]
AID - 10.1016/j.ijrobp.2017.02.002 [doi]
PST - ppublish
SO  - Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):409-418. doi: 
      10.1016/j.ijrobp.2017.02.002. Epub 2017 Feb 10.