PMID- 25265940 OWN - NLM STAT- MEDLINE DCOM- 20141114 LR - 20240321 IS - 1460-2105 (Electronic) IS - 0027-8874 (Print) IS - 0027-8874 (Linking) VI - 106 IP - 9 DP - 2014 Sep TI - Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). LID - dju244 [pii] LID - 10.1093/jnci/dju244 [doi] AB - The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research. CI - (c) The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com. FAU - Basch, Ethan AU - Basch E AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). ebasch@med.unc.edu. FAU - Reeve, Bryce B AU - Reeve BB AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Mitchell, Sandra A AU - Mitchell SA AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Clauser, Steven B AU - Clauser SB AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Minasian, Lori M AU - Minasian LM AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Dueck, Amylou C AU - Dueck AC AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Mendoza, Tito R AU - Mendoza TR AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Hay, Jennifer AU - Hay J AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Atkinson, Thomas M AU - Atkinson TM AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Abernethy, Amy P AU - Abernethy AP AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Bruner, Deborah W AU - Bruner DW AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Cleeland, Charles S AU - Cleeland CS AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Sloan, Jeff A AU - Sloan JA AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Chilukuri, Ram AU - Chilukuri R AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Baumgartner, Paul AU - Baumgartner P AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Denicoff, Andrea AU - Denicoff A AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - St Germain, Diane AU - St Germain D AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - O'Mara, Ann M AU - O'Mara AM AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Chen, Alice AU - Chen A AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Kelaghan, Joseph AU - Kelaghan J AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Bennett, Antonia V AU - Bennett AV AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Sit, Laura AU - Sit L AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Rogak, Lauren AU - Rogak L AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Barz, Allison AU - Barz A AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Paul, Diane B AU - Paul DB AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). FAU - Schrag, Deborah AU - Schrag D AD - : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). LA - eng GR - HHSN261201000063C/CA/NCI NIH HHS/United States GR - HHSN261201000043C/CA/NCI NIH HHS/United States GR - P30 CA008748/CA/NCI NIH HHS/United States GR - K05 CA169384/CA/NCI NIH HHS/United States GR - P30 CA015083/CA/NCI NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20140929 PL - United States TA - J Natl Cancer Inst JT - Journal of the National Cancer Institute JID - 7503089 RN - 0 (Antineoplastic Agents) SB - IM MH - *Adverse Drug Reaction Reporting Systems MH - Antineoplastic Agents/*adverse effects MH - Humans MH - National Cancer Institute (U.S.) MH - Neoplasms/*drug therapy MH - Patient Outcome Assessment MH - *Self Report MH - Surveys and Questionnaires MH - *Terminology as Topic MH - United States PMC - PMC4200059 EDAT- 2014/10/01 06:00 MHDA- 2014/11/15 06:00 PMCR- 2015/09/01 CRDT- 2014/10/01 06:00 PHST- 2014/10/01 06:00 [entrez] PHST- 2014/10/01 06:00 [pubmed] PHST- 2014/11/15 06:00 [medline] PHST- 2015/09/01 00:00 [pmc-release] AID - dju244 [pii] AID - 10.1093/jnci/dju244 [doi] PST - epublish SO - J Natl Cancer Inst. 2014 Sep 29;106(9):dju244. doi: 10.1093/jnci/dju244. Print 2014 Sep.