title: Recommended patient-reported core set of symptoms to measure in prostate cancer treatment trials.
abstract: The National Cancer Institute (NCI) Symptom Management and Health-Related Quality of Life Steering Committee convened four working groups to recommend core sets of patient-reported outcomes to be routinely incorporated in clinical trials. The Prostate Cancer Working Group included physicians, researchers, and a patient advocate. The group's process included 1) a systematic literature review to determine the prevalence and severity of symptoms, 2) a multistakeholder meeting sponsored by the NCI to review the evidence and build consensus, and 3) a postmeeting expert panel synthesis of findings to finalize recommendations. Five domains were recommended for localized prostate cancer: urinary incontinence, urinary obstruction and irritation, bowel-related symptoms, sexual dysfunction, and hormonal symptoms. Four domains were recommended for advanced prostate cancer: pain, fatigue, mental well-being, and physical well-being. Additional domains for consideration include decisional regret, satisfaction with care, and anxiety related to prostate cancer. These recommendations have been endorsed by the NCI for implementation.
authors.affiliation: Affiliations of authors: Department of Radiation Oncology (RCC, WAS), and Department of Health Policy and Management, Gillings School of Global Public Health (BBR), Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC (RCC, WAS); Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (PC); Mayo Clinic, Rochester, MN (RJV); Juravinski Cancer Centre and McMaster University, Hamilton, Ontario, Canada (HL); Department of Urology (MGS), and Nell Hodgson Woodruff School of Nursing (DW-G), Emory University, Atlanta, GA; Department of Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA (HMS). ronald_chen@med.unc.edu.
authors.forename: Ronald C
authors.initials: RC
authors.lastname: Chen
authors.affiliation: Affiliations of authors: Department of Radiation Oncology (RCC, WAS), and Department of Health Policy and Management, Gillings School of Global Public Health (BBR), Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC (RCC, WAS); Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (PC); Mayo Clinic, Rochester, MN (RJV); Juravinski Cancer Centre and McMaster University, Hamilton, Ontario, Canada (HL); Department of Urology (MGS), and Nell Hodgson Woodruff School of Nursing (DW-G), Emory University, Atlanta, GA; Department of Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA (HMS).
authors.forename: Peter
authors.initials: P
authors.lastname: Chang
authors.affiliation: Affiliations of authors: Department of Radiation Oncology (RCC, WAS), and Department of Health Policy and Management, Gillings School of Global Public Health (BBR), Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC (RCC, WAS); Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (PC); Mayo Clinic, Rochester, MN (RJV); Juravinski Cancer Centre and McMaster University, Hamilton, Ontario, Canada (HL); Department of Urology (MGS), and Nell Hodgson Woodruff School of Nursing (DW-G), Emory University, Atlanta, GA; Department of Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA (HMS).
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Vetter
authors.affiliation: Affiliations of authors: Department of Radiation Oncology (RCC, WAS), and Department of Health Policy and Management, Gillings School of Global Public Health (BBR), Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC (RCC, WAS); Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (PC); Mayo Clinic, Rochester, MN (RJV); Juravinski Cancer Centre and McMaster University, Hamilton, Ontario, Canada (HL); Department of Urology (MGS), and Nell Hodgson Woodruff School of Nursing (DW-G), Emory University, Atlanta, GA; Department of Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA (HMS).
authors.forename: Himansu
authors.initials: H
authors.lastname: Lukka
authors.affiliation: Affiliations of authors: Department of Radiation Oncology (RCC, WAS), and Department of Health Policy and Management, Gillings School of Global Public Health (BBR), Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC (RCC, WAS); Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (PC); Mayo Clinic, Rochester, MN (RJV); Juravinski Cancer Centre and McMaster University, Hamilton, Ontario, Canada (HL); Department of Urology (MGS), and Nell Hodgson Woodruff School of Nursing (DW-G), Emory University, Atlanta, GA; Department of Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA (HMS).
authors.forename: William A
authors.initials: WA
authors.lastname: Stokes
authors.affiliation: Affiliations of authors: Department of Radiation Oncology (RCC, WAS), and Department of Health Policy and Management, Gillings School of Global Public Health (BBR), Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC (RCC, WAS); Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (PC); Mayo Clinic, Rochester, MN (RJV); Juravinski Cancer Centre and McMaster University, Hamilton, Ontario, Canada (HL); Department of Urology (MGS), and Nell Hodgson Woodruff School of Nursing (DW-G), Emory University, Atlanta, GA; Department of Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA (HMS).
authors.forename: Martin G
authors.initials: MG
authors.lastname: Sanda
authors.affiliation: Affiliations of authors: Department of Radiation Oncology (RCC, WAS), and Department of Health Policy and Management, Gillings School of Global Public Health (BBR), Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC (RCC, WAS); Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (PC); Mayo Clinic, Rochester, MN (RJV); Juravinski Cancer Centre and McMaster University, Hamilton, Ontario, Canada (HL); Department of Urology (MGS), and Nell Hodgson Woodruff School of Nursing (DW-G), Emory University, Atlanta, GA; Department of Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA (HMS).
authors.forename: Deborah
authors.initials: D
authors.lastname: Watkins-Bruner
authors.affiliation: Affiliations of authors: Department of Radiation Oncology (RCC, WAS), and Department of Health Policy and Management, Gillings School of Global Public Health (BBR), Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC (RCC, WAS); Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (PC); Mayo Clinic, Rochester, MN (RJV); Juravinski Cancer Centre and McMaster University, Hamilton, Ontario, Canada (HL); Department of Urology (MGS), and Nell Hodgson Woodruff School of Nursing (DW-G), Emory University, Atlanta, GA; Department of Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA (HMS).
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.affiliation: Affiliations of authors: Department of Radiation Oncology (RCC, WAS), and Department of Health Policy and Management, Gillings School of Global Public Health (BBR), Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC (RCC, WAS); Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (PC); Mayo Clinic, Rochester, MN (RJV); Juravinski Cancer Centre and McMaster University, Hamilton, Ontario, Canada (HL); Department of Urology (MGS), and Nell Hodgson Woodruff School of Nursing (DW-G), Emory University, Atlanta, GA; Department of Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA (HMS).
authors.forename: Howard M
authors.initials: HM
authors.lastname: Sandler
mesh_terms: D001007:Anxiety / Q000209:etiology; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards / Q000639:trends; D003657:Decision Making; D007172:Erectile Dysfunction / Q000209:etiology; D005221:Fatigue / Q000209:etiology; D006304:Health Status; D006801:Humans; D007420:Intestine, Large / Q000503:physiopathology; D008297:Male; D054547:National Cancer Institute (U.S.); D017060:Patient Satisfaction; D011471:Prostatic Neoplasms / Q000150:complications* / Q000453:epidemiology / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D057566:Self Report; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014549:Urinary Incontinence / Q000209:etiology; D016055:Urinary Retention / Q000209:etiology; D059265:Visceral Pain / Q000209:etiology