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Determining Parental Factors for Clinical Trial Attrition in Pediatric Acute Lymphoblastic Leukemia
Kimberly L Stathas1, Jakob Q Weiss1, Kellee N Parker2
1School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin, USA.
Background/Objectives:
Despite high enrollment rates on Children's Oncology Group (COG) protocols, attrition after initial consent is challenging, introducing bias and prolonging trial completion. While adult oncology literature has identified predictors of withdrawal, little is known about caregiver decision-making for child participation in trials. This study explored caregiver perspectives on enrollment and attrition in COG trials for B-acute lymphoblastic leukemia (B-ALL), and identified factors influencing decision-making and strategies to support retention.
Methods/Design:
Semi-structured interviews were conducted at two institutions with 21 caregivers of children who either remained on or withdrew from a therapeutic trial for B-ALL between 2018 and 2024. Inductive reflexive thematic analysis was used with independent dual coding and iterative codebook refinement.
Results:
Five themes influencing trial decision-making were identified: (1) factors supporting continued participation (retention), including trust in clinical team, belief in scientific benefit, and active information-seeking; (2) opposing factors for consenting to remain on trial (attrition) including emotional overload, logistical and financial burden, fear of harm, and uncertainty regarding treatment efficacy; (3) evolving caregiver decision-making and child involvement over time; (4) perceptions of treatment intensity, including de-escalation concerns; and (5) the need for accessible, re-visitable educational resources to support sustained participation.
Conclusions:
Caregiver clinical trial decision-making is dynamic and evolves over time, with emotional burden, logistical challenges, and perceptions of treatment risk driving attrition. Longitudinal communication, simplified and re-visitable consent resources, and interventions that reduce participation burden may improve retention. These findings highlight the importance of supporting caregivers beyond initial consent to optimize retention and support for families.
