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 At our institution, 40% of children enrolled on AALL0932 were withdrawn from protocol therapy prior to randomization due to parental choice.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.

Parental experiences of the informed consent process in randomized clinical trials—A Nordic study

“…The outcome of an RCT is per definition uncertain, and the decision whether to participate is based on several factors, including how the family perceives the individual risks and benefits for their child. 24,28,34 This is reflected in our study, where most of the non-consenters stated that their main reason not to participate was a fear that it would result in inferior treatment outcomes for their child. Many of the parents also expressed feeling that it was too difficult to make this decision due to the potential implications for their child.…”

“…To have your child diagnosed with a life‐threatening disease is a disrupting situation for a family, and the request for RCT participation was (for the two larger studies within this protocol) presented within the first month after diagnosis. The outcome of an RCT is per definition uncertain, and the decision whether to participate is based on several factors, including how the family perceives the individual risks and benefits for their child 24,28,34 . This is reflected in our study, where most of the non‐consenters stated that their main reason not to participate was a fear that it would result in inferior treatment outcomes for their child.…”

“…Previous studies within pediatric oncology trials have found that parents often do not understand the concept of randomization and poorly recall key issues from the consent discussion, including voluntariness, side effects, and purpose of the trial [15][16][17][18][19] and have aimed at identifying barriers and factors to facilitate the informed consent process. [20][21][22][23] Identified factors that influence a parent's decision to consent to RCT participation in other pediatric settings [24][25][26][27] or in smaller subsets 18,28 include altruism and trust in the medical team, but also beliefs of risks/benefits for their own child.…”

“There's no playbook for when your kid has cancer”: Desired elements of an electronic resource to support pediatric cancer communication

“…Beyond meeting patients’ and parents’ stated needs, and supporting decision‐making, 33 an interactive resource may help improve clinical outcomes. A structured caregiver educational program for parents of children with cancer in Chile improved parent knowledge, and was also associated with decreased rates of central line infections and fewer visits to the emergency department 34 .…”

Parents’ experiences of being involved in medical decision-making for their child with a life-limiting condition: A systematic review with narrative synthesis

“…The overall experience was described by many parents as overwhelming, scary, heavy, horrible, painful, gut-wrenching, horrific and emotionally exhausting. 40,48,50,52,56,57,62 Some parents experienced inner conflict and cognitive dissonance, which then affected their ability to make decisions. 48,52,56,57 For others, the decision-making process was a frustrating experience, especially when the decision did not lead to the expected outcome or when parents felt they were not involved in the process.…”