Peer-reviewed article
Determining Parental Factors for Clinical Trial Attrition in Pediatric Acute Lymphoblastic Leukemia.
Stathas KL, Weiss JQ, Parker KN, Lee-Miller C ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study explored why parents withdraw their children from clinical trials for acute lymphoblastic leukemia, a serious blood cancer. Researchers interviewed 21 caregivers at two US institutions to understand what makes them stay in or leave trials. The main reasons parents stayed were trust in doctors and belief the trial would help; reasons they left included emotional stress, travel and financial costs, fear of side effects, and doubts about whether the treatment would work. The study recommends improving communication with families and reducing the practical burdens of trial participation.
Key points
- Five themes identified: retention factors (trust, scientific belief, information-seeking), attrition factors (emotional overload, logistical/financial burden, fear of harm, treatment efficacy uncertainty), evolving decision-making, perceptions of treatment intensity, and need for accessible educatio
- Caregiver decision-making about trial participation is dynamic and changes over time, not fixed at initial consent
- Emotional burden, logistical challenges, and perceptions of treatment risk are key drivers of trial attrition
- Parents expressed concerns about de-escalation of treatment intensity during trials
- Longitudinal communication and simplified re-visitable consent resources are needed to improve retention
Limitations
This qualitative study included only 21 caregivers at two institutions, so findings may not generalise to other cancer types, settings, or populations. The study cannot quantify how common each factor is or predict which families are most likely to withdraw.
Abstract
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.