title: Recommended patient-reported core set of symptoms and quality-of-life domains to measure in ovarian cancer treatment trials.
abstract: There is no consensus as to what symptoms or quality-of-life (QOL) domains should be measured as patient-reported outcomes (PROs) in ovarian cancer clinical trials. A panel of experts convened by the National Cancer Institute reviewed studies published between January 2000 and August 2011. The results were included in and combined with an expert consensus-building process to identify the most salient PROs for ovarian cancer clinical trials. We identified a set of PROs specific to ovarian cancer: abdominal pain, bloating, cramping, fear of recurrence/disease progression, indigestion, sexual dysfunction, vomiting, weight gain, and weight loss. Additional PROs identified in parallel with a group charged with identifying the most important PROs across cancer types were anorexia, cognitive problems, constipation, diarrhea, dyspnea, fatigue, nausea, neuropathy, pain, and insomnia. Physical and emotional domains were considered to be the most salient domains of QOL. Findings of the review and consensus process provide good support for use of these ovarian cancer-specific PROs in ovarian cancer clinical trials.
authors.affiliation: Affiliations of authors: Supportive Care Medicine Department, Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL (KAD); Acute and Tertiary Care Department, University of Pittsburgh School of Nursing, Pittsburgh, PA (HSD); Department of Medical Social Sciences and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (DC); Center for Patient Partnership, University of Wisconsin Law School, Madison, WI (MEG); Department of Medicine, Massachusetts General Hospital, Boston, MA (RTP); Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California-San Diego, San Diego, CA (SCP); Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Summa Akron City Hospital, Akron, OH (VEvG); School of Nursing, Emory University, Atlanta, GA (DWB); Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC (BBR); Department of Medicine, University of California, Irvine, Irvine, CA (LW).
authors.forename: Kristine A
authors.initials: KA
authors.lastname: Donovan
authors.affiliation: Affiliations of authors: Supportive Care Medicine Department, Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL (KAD); Acute and Tertiary Care Department, University of Pittsburgh School of Nursing, Pittsburgh, PA (HSD); Department of Medical Social Sciences and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (DC); Center for Patient Partnership, University of Wisconsin Law School, Madison, WI (MEG); Department of Medicine, Massachusetts General Hospital, Boston, MA (RTP); Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California-San Diego, San Diego, CA (SCP); Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Summa Akron City Hospital, Akron, OH (VEvG); School of Nursing, Emory University, Atlanta, GA (DWB); Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC (BBR); Department of Medicine, University of California, Irvine, Irvine, CA (LW).
authors.forename: Heidi S
authors.initials: HS
authors.lastname: Donovan
authors.affiliation: Affiliations of authors: Supportive Care Medicine Department, Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL (KAD); Acute and Tertiary Care Department, University of Pittsburgh School of Nursing, Pittsburgh, PA (HSD); Department of Medical Social Sciences and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (DC); Center for Patient Partnership, University of Wisconsin Law School, Madison, WI (MEG); Department of Medicine, Massachusetts General Hospital, Boston, MA (RTP); Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California-San Diego, San Diego, CA (SCP); Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Summa Akron City Hospital, Akron, OH (VEvG); School of Nursing, Emory University, Atlanta, GA (DWB); Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC (BBR); Department of Medicine, University of California, Irvine, Irvine, CA (LW).
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.affiliation: Affiliations of authors: Supportive Care Medicine Department, Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL (KAD); Acute and Tertiary Care Department, University of Pittsburgh School of Nursing, Pittsburgh, PA (HSD); Department of Medical Social Sciences and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (DC); Center for Patient Partnership, University of Wisconsin Law School, Madison, WI (MEG); Department of Medicine, Massachusetts General Hospital, Boston, MA (RTP); Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California-San Diego, San Diego, CA (SCP); Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Summa Akron City Hospital, Akron, OH (VEvG); School of Nursing, Emory University, Atlanta, GA (DWB); Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC (BBR); Department of Medicine, University of California, Irvine, Irvine, CA (LW).
authors.forename: Martha E
authors.initials: ME
authors.lastname: Gaines
authors.affiliation: Affiliations of authors: Supportive Care Medicine Department, Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL (KAD); Acute and Tertiary Care Department, University of Pittsburgh School of Nursing, Pittsburgh, PA (HSD); Department of Medical Social Sciences and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (DC); Center for Patient Partnership, University of Wisconsin Law School, Madison, WI (MEG); Department of Medicine, Massachusetts General Hospital, Boston, MA (RTP); Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California-San Diego, San Diego, CA (SCP); Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Summa Akron City Hospital, Akron, OH (VEvG); School of Nursing, Emory University, Atlanta, GA (DWB); Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC (BBR); Department of Medicine, University of California, Irvine, Irvine, CA (LW).
authors.forename: Richard T
authors.initials: RT
authors.lastname: Penson
authors.affiliation: Affiliations of authors: Supportive Care Medicine Department, Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL (KAD); Acute and Tertiary Care Department, University of Pittsburgh School of Nursing, Pittsburgh, PA (HSD); Department of Medical Social Sciences and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (DC); Center for Patient Partnership, University of Wisconsin Law School, Madison, WI (MEG); Department of Medicine, Massachusetts General Hospital, Boston, MA (RTP); Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California-San Diego, San Diego, CA (SCP); Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Summa Akron City Hospital, Akron, OH (VEvG); School of Nursing, Emory University, Atlanta, GA (DWB); Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC (BBR); Department of Medicine, University of California, Irvine, Irvine, CA (LW).
authors.forename: Steven C
authors.initials: SC
authors.lastname: Plaxe
authors.affiliation: Affiliations of authors: Supportive Care Medicine Department, Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL (KAD); Acute and Tertiary Care Department, University of Pittsburgh School of Nursing, Pittsburgh, PA (HSD); Department of Medical Social Sciences and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (DC); Center for Patient Partnership, University of Wisconsin Law School, Madison, WI (MEG); Department of Medicine, Massachusetts General Hospital, Boston, MA (RTP); Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California-San Diego, San Diego, CA (SCP); Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Summa Akron City Hospital, Akron, OH (VEvG); School of Nursing, Emory University, Atlanta, GA (DWB); Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC (BBR); Department of Medicine, University of California, Irvine, Irvine, CA (LW).
authors.forename: Vivian E
authors.initials: VE
authors.lastname: von Gruenigen
authors.affiliation: Affiliations of authors: Supportive Care Medicine Department, Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL (KAD); Acute and Tertiary Care Department, University of Pittsburgh School of Nursing, Pittsburgh, PA (HSD); Department of Medical Social Sciences and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (DC); Center for Patient Partnership, University of Wisconsin Law School, Madison, WI (MEG); Department of Medicine, Massachusetts General Hospital, Boston, MA (RTP); Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California-San Diego, San Diego, CA (SCP); Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Summa Akron City Hospital, Akron, OH (VEvG); School of Nursing, Emory University, Atlanta, GA (DWB); Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC (BBR); Department of Medicine, University of California, Irvine, Irvine, CA (LW).
authors.forename: Deborah Watkins
authors.initials: DW
authors.lastname: Bruner
authors.affiliation: Affiliations of authors: Supportive Care Medicine Department, Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL (KAD); Acute and Tertiary Care Department, University of Pittsburgh School of Nursing, Pittsburgh, PA (HSD); Department of Medical Social Sciences and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (DC); Center for Patient Partnership, University of Wisconsin Law School, Madison, WI (MEG); Department of Medicine, Massachusetts General Hospital, Boston, MA (RTP); Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California-San Diego, San Diego, CA (SCP); Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Summa Akron City Hospital, Akron, OH (VEvG); School of Nursing, Emory University, Atlanta, GA (DWB); Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC (BBR); Department of Medicine, University of California, Irvine, Irvine, CA (LW).
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.affiliation: Affiliations of authors: Supportive Care Medicine Department, Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL (KAD); Acute and Tertiary Care Department, University of Pittsburgh School of Nursing, Pittsburgh, PA (HSD); Department of Medical Social Sciences and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (DC); Center for Patient Partnership, University of Wisconsin Law School, Madison, WI (MEG); Department of Medicine, Massachusetts General Hospital, Boston, MA (RTP); Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California-San Diego, San Diego, CA (SCP); Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Summa Akron City Hospital, Akron, OH (VEvG); School of Nursing, Emory University, Atlanta, GA (DWB); Department of Health Policy and Management, University of North Carolina, Chapel Hill, NC (BBR); Department of Medicine, University of California, Irvine, Irvine, CA (LW). lwenzel@uci.edu.
authors.forename: Lari
authors.initials: L
authors.lastname: Wenzel
mesh_terms: D000855:Anorexia / Q000209:etiology; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards / Q000639:trends; D003248:Constipation / Q000209:etiology; D003967:Diarrhea / Q000209:etiology; D005221:Fatigue / Q000209:etiology; D005260:Female; D006304:Health Status; D006801:Humans; D054547:National Cancer Institute (U.S.); D009325:Nausea / Q000209:etiology; D010051:Ovarian Neoplasms / Q000150:complications* / Q000453:epidemiology / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D057566:Self Report; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D059265:Visceral Pain / Q000209:etiology; D014839:Vomiting / Q000209:etiology
chemical_list: D000970:Antineoplastic Agents