title: Strategies to improve success of pediatric cancer cooperative group quality of life studies: a report from the Children's Oncology Group.
abstract: OBJECTIVE
  Quality of life (QoL) has been increasingly emphasized in National Cancer Institute (NCI)-sponsored multisite clinical trials. Little is known about the outcomes of these trials in pediatric cancer. Objectives were to describe the proportion of Children's Oncology Group (COG) QoL studies that successfully accrued subjects and were analyzed, presented or published.
  
  
  METHODS
  We conducted a survey to describe outcomes of COG QoL studies. We included studies that contained at least one QoL assessment and were closed to patient accrual at the time of survey dissemination. Respondents were the investigators most responsible for the QoL aim.
  
  
  RESULTS
  Sixteen studies were included; response rate was 100%. Nine (56%) studies were embedded into a cancer treatment trial. Only 3 (19%) studies accrued their intended sample size. Seven (44%) studies were analyzed, 9 (56%) were presented, and 6 (38%) were published.
  
  
  CONCLUSIONS
  NCI-sponsored pediatric QoL studies have high rates of failure to accrue. Many were not analyzed or disseminated. Using these data, strategies have been implemented to improve conduct in future trials. Monitoring of QoL studies is important to maximize the chances of study success.
authors.affiliation: Division of Oncology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave ML 7015, Cincinnati, OH, 45229, USA, puja.whitlow@cchmc.org.
authors.forename: Puja G
authors.initials: PG
authors.lastname: Whitlow
authors.forename: Mae
authors.initials: M
authors.lastname: Caparas
authors.forename: Patricia
authors.initials: P
authors.lastname: Cullen
authors.forename: Christine
authors.initials: C
authors.lastname: Trask
authors.forename: Fiona
authors.initials: F
authors.lastname: Schulte
authors.forename: Leanne
authors.initials: L
authors.lastname: Embry
authors.forename: Rajaram
authors.initials: R
authors.lastname: Nagarajan
authors.forename: Donna L
authors.initials: DL
authors.lastname: Johnston
authors.forename: Lillian
authors.initials: L
authors.lastname: Sung
mesh_terms: D035843:Biomedical Research; D002648:Child; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000628:therapy*; D010372:Pediatrics; D011788:Quality of Life; D011795:Surveys and Questionnaires; D014481:United States