Accrual in supportive care trials in pediatric oncology, a challenge

• Published in: Supportive care in cancer Vol. 20; no. 12; pp. 3149 - 3153
• Main Authors: Schoot, R. A., van Ommen, C. H., Caron, H. N., Tissing, W. J. E., van de Wetering, M. D.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01-12-2012; Springer; Springer Nature B.V
• Subjects: Attitude of Health Personnel; Child; Clinical trials; Clinical Trials as Topic; Health aspects; Health Knowledge, Attitudes, Practice; Humans; Medicine; Medicine & Public Health; Neoplasms - therapy; Nursing; Nursing Research; Oncology; Original; Original Article; Pain Medicine; Patient Selection; Pediatrics; Recruitment; Rehabilitation Medicine; Pediatric oncology; Supportive care; Accrual; Patient enrolment; Catheter-related infections
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-012-1447-2

Purpose
Treatment protocols in pediatric oncology have historically known high accrual rates, up to 94 %. Accrual for supportive care studies on the other hand appears to be a challenge. The aim of this study was to search for reasons explaining this poor accrual and for possible interventions to improve patient enrolment.
Methods
The failure screen log of our supportive care study (the Aristocaths study) was analyzed, and subsequently, a literature search was performed.
Results
The literature search (1985–2011) revealed three factors that can influence accrual. Firstly, study implementation and patient enrolment can be facilitated by appointing a dedicated clinical investigator in all participating centers and by facilitating clinical research nurses. Furthermore, adequate and tailor-made information is required for families to make a well-informed decision regarding study participation. Lastly, sufficient time should be assured for the process of decision making, especially since the number of eligible studies is increasing rapidly. Concerning our study, all three elements were met, but the most striking finding was the presumed burden of study participation by the majority of parents (82 %) as the main argument against randomization.
Conclusions
Accrual of pediatric oncology patients in supportive care studies is challenging. Nevertheless, well-designed randomized controlled trials in supportive care will be essential for the improvement of pediatric cancer care. Therefore, we will need to increase awareness through (inter)national supportive care working groups regarding the need for supportive care trials and stimulate accrual when such trials are open.