title: Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials.
abstract: BACKGROUND
  The 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).
  
  
  METHODS
  We 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.
  
  
  RESULTS
  We 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.
  
  
  CONCLUSIONS
  This 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.
authors.affiliation: 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.
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.affiliation: 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).
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Mitchell
authors.affiliation: 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).
authors.forename: Amylou C
authors.initials: AC
authors.lastname: Dueck
authors.affiliation: 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).
authors.forename: Ethan
authors.initials: E
authors.lastname: Basch
authors.affiliation: 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).
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.affiliation: 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).
authors.forename: Carolyn Miller
authors.initials: CM
authors.lastname: Reilly
authors.affiliation: 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).
authors.forename: Lori M
authors.initials: LM
authors.lastname: Minasian
authors.affiliation: 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).
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Denicoff
authors.affiliation: 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).
authors.forename: Ann M
authors.initials: AM
authors.lastname: O'Mara
authors.affiliation: 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).
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Fisch
authors.affiliation: 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).
authors.forename: Cynthia
authors.initials: C
authors.lastname: Chauhan
authors.affiliation: 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).
authors.forename: Neil K
authors.initials: NK
authors.lastname: Aaronson
authors.affiliation: 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).
authors.forename: Corneel
authors.initials: C
authors.lastname: Coens
authors.affiliation: 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).
authors.forename: Deborah Watkins
authors.initials: DW
authors.lastname: Bruner
mesh_terms: D000328:Adult; D000855:Anorexia / Q000209:etiology; D001007:Anxiety / Q000209:etiology; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards / Q000639:trends; D060825:Cognitive Dysfunction / Q000209:etiology; D003248:Constipation / Q000209:etiology; D003863:Depression / Q000209:etiology; D003967:Diarrhea / Q000209:etiology; D004417:Dyspnea / Q000209:etiology; D005221:Fatigue / Q000209:etiology; D005260:Female; D006304:Health Status; D006801:Humans; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000150:complications* / Q000453:epidemiology / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D010146:Pain / Q000209:etiology; D010523:Peripheral Nervous System Diseases / Q000209:etiology; D015995:Prevalence; D011788:Quality of Life; D057566:Self Report; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000209:etiology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology