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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.

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.

Author information

1
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.
2
NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
3
Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona.
4
Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, Rockville, Maryland.
5
Radiation Oncology, University of South Florida, Tampa, Florida.
6
Department of Radiation Oncology, University of California, San Francisco, San Francisco, California.
7
Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
8
Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.
9
Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
10
Department of Symptom Research, The University of Texas MD. Anderson Cancer Center, Houston, Texas.
11
Setser Health Consulting, LLC, St. Louis, Missouri.
12
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
13
Southeast Radiation Oncology, Southeast Community Cancer Consortium Nation Cancer NCI Community Oncology Research Program (NCORP), Charlotte, North Carolina.
14
Department of Oncology Administration, Wellspan Adams Cancer Center, York, Pennsylvania.
15
Radiation Oncology, Geisinger Medical Center Community Clinical Oncology Program (CCOP), Danville, Pennsylvania.
16
Radiation Oncology, Cleveland Clinic Foundation, Cleveland, Ohio.
17
Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
18
Radiation Oncology, Main Line CCOP, Wynnewood, Pennsylvania.

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.

PMID:
28463161
PMCID:
PMC5557037
DOI:
10.1016/j.ijrobp.2017.02.002
[Indexed for MEDLINE]
Free PMC Article

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