• Bryce B Reeve, Sandra A Mitchell, Amylou C Dueck, Ethan Basch, David Cella, Carolyn Miller Reilly, Lori M Minasian, Andrea M Denicoff, Ann M O'Mara, Michael J Fisch, Cynthia Chauhan, Neil K Aaronson, Corneel Coens, and Deborah Watkins Bruner.
• Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo). bbreeve@email.unc.edu.
• J. Natl. Cancer Inst. 2014 Jul 1;106(7).

BackgroundThe National Cancer Institute's Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO).MethodsWe used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001-2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment.ResultsWe recommend that a core set of 12 symptoms--specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea--be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients.ConclusionsThis core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies.© The Author 2014. Published by Oxford University Press. All rights reserved.

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