Strategies to improve success of pediatric cancer cooperative group quality of life studies: a report from the Children’s Oncology Group
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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.
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.
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.
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.
KeywordsQuality of life Pediatric cancer Supportive care Multicenter clinical trials
The authors would like to thank David Freyer, Brad Pollack, Ann O’Mara and Pam Hinds for their assistance in identifying eligible studies. This study was funded by Children’s Oncology Group Grant CA 98543 (Chair’s Grant), CA 180886 (NCTN Operation Center Grant), CA 98413 (Statistics and Data Center Grant) and CA 180899 (NCTN Statistics and Data Center Grant). The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.
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