title: Quality-of-life assessment in the symptom management trials of the National Cancer Institute-supported Community Clinical Oncology Program.
abstract: OBJECTIVE
  To examine how quality of life (QOL) is prospectively conceptualized, defined, and measured in the symptom management clinical trials supported by the National Cancer Institute Community Clinical Oncology Program (CCOP).
  
  
  METHODS
  All QOL research objectives, rationales, assessment instruments, symptoms treated, and types of interventions from the CCOP symptom management portfolio of clinical trials were extracted and analyzed.
  
  
  RESULTS
  QOL assessments were proposed in 68 (52%) of the 130 total CCOP symptom management trials initiated since 1987. A total of 22 global QOL instruments were identified. Both the frequency of symptom management trials and the frequency of QOL assessment have increased significantly over time. The Functional Assessment of Cancer Therapy and Uniscale instruments were the most widely used QOL instruments, included in 55% of trials assessing QOL. The conceptual framework for QOL inclusion was limited to univariate relationships between symptom relief and global improvements in QOL. No consistent associations were found between QOL assessment and either the symptoms targeted or types of interventions.
  
  
  CONCLUSIONS
  To advance the state of the science, research protocols need to provide more explicit rationales for assessing QOL in symptom management trials and for the selection of the QOL instrument(s) to be used. Conceptual frameworks that specify the hypothesized links between the specific symptom(s) being managed, interactions with other symptoms, different domains of QOL, and global QOL also need to be more precisely described. Methodologic and conceptual advances in QOL symptom management trials are critical to fulfill the promise of alleviating suffering and improving the QOL of cancer patients.
authors.affiliation: Division of Cancer Prevention, National Cancer Institute/NIH, 6130 Executive Blvd, Room EPN 2149, Bethesda, MD 20892-7317, USA. buchanad@mail.nih.gov
authors.forename: David R
authors.initials: DR
authors.lastname: Buchanan
authors.forename: Ann M
authors.initials: AM
authors.lastname: O'Mara
authors.forename: Joseph W
authors.initials: JW
authors.lastname: Kelaghan
authors.forename: Lori M
authors.initials: LM
authors.lastname: Minasian
mesh_terms: D002986:Clinical Trials as Topic; D003625:Data Collection; D023381:Endpoint Determination; D006801:Humans; D008495:Medical Oncology / Q000706:statistics & numerical data; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D009316:National Institutes of Health (U.S.); D009369:Neoplasms / Q000150:complications* / Q000628:therapy; D011446:Prospective Studies; D011788:Quality of Life; D014481:United States