@article{20b9634637924628aa05c94d5a9f6624,
title = "Parental decision making regarding consent to randomization on Children's Oncology Group AALL0932",
abstract = "Background: Within pediatric oncology, parental decision making regarding participation in clinical trials that aim to reduce therapy to mitigate side effects is not well studied. The recently completed Children's Oncology Group trial for standard-risk acute lymphoblastic leukemia (AALL0932) included a reduction in maintenance therapy, and required consent for randomization immediately prior to starting maintenance. At our institution, 40% of children enrolled on AALL0932 were withdrawn from protocol therapy prior to randomization due to parental choice. This study sought to identify factors that impacted parental decision making regarding randomization on AALL0932. Procedure: Parents of children enrolled on AALL0932 at our institution were eligible if their child met criteria for the average-risk randomization. Parents were invited to participate in a 30-50-minute phone interview. Questions focused on factors that shaped parental decision making about randomization, as well as their perspectives about the clinical trial experience more generally. Results: Fear of receiving less therapy and subsequent relapse was the predominant reason to decline randomization. Reasons given for consenting to randomization included trust in the physician, altruism, hope for less therapy, and potential for fewer side effects. Parents also reflected on ways to support future families making decisions about clinical trial participation. Conclusion: While many parents recognize the importance of clinical trials aiming to mitigate side effects, the fear of their own child relapsing with less than standard therapy may dissuade them from study participation. Recognizing and addressing these concerns will be important for enrollment and retention in future clinical trials.",
keywords = "AALL0932, clinical trials, decision making, oncology, pediatric",
author = "Kellee Parker and Erika Cottrell and Linda Stork and Susan Lindemulder",
note = "Funding Information: This publication was supported by the Oregon Clinical and Translational Research Institute (OCTRI), Grant Number TL1 TR 002371 from the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). It was also supported in part by the OCTRI's Health Experiences Research Network program, funded by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR002369. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The authors wish to thank Anne Angiolillo, MD and John Kairalla, PhD for providing personal communication regarding the randomization refusal and consent withdrawal rates for AALL0932. The authors also wish to thank the parents who volunteered their time to complete interviews and share their experiences for this study. Funding Information: This publication was supported by the Oregon Clinical and Translational Research Institute (OCTRI), Grant Number TL1 TR 002371 from the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). It was also supported in part by the OCTRI's Health Experiences Research Network program, funded by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR002369. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The authors wish to thank Anne Angiolillo, MD and John Kairalla, PhD for providing personal communication regarding the randomization refusal and consent withdrawal rates for AALL0932. The authors also wish to thank the parents who volunteered their time to complete interviews and share their experiences for this study. Publisher Copyright: {\textcopyright} 2021 Wiley Periodicals LLC",
year = "2021",
month = apr,
doi = "10.1002/pbc.28907",
language = "English (US)",
volume = "68",
journal = "Medical and Pediatric Oncology",
issn = "1545-5009",
publisher = "Wiley-Liss Inc.",
number = "4",
}