Integrated service delivery to improve adolescent health and human papillomavirus (HPV) vaccination in Lao PDR: a quasi-experimental mixed-methods study - study protocol.

Pediatric oncology clinical trials (POCTs) have historically allowed for dramatic improvements in the survival and quality of life of children diagnosed with cancer []. Despite these advances, clinical trials in oncology remain vulnerable to early termination, often attributed to poor accrual []. Early termination, along with initial referral and the inclusion of a child in a POCT, however, reflect a complex interplay of factors, including trial availability, funding issues, logistical issues, local and national consensus for treatment options, and family-level decision-making processes [–]. Many of these contributors lie outside the control of individual care teams. Others, particularly those related to caregiver decision-making under conditions of psychosocial distress [, ], are likely modifiable. We recognize, however, that poor accrual and retention in POCTs are driven by multiple structural, protocol-level, and logistical factors, including trial availability, eligibility restrictions, and age-related disparities in enrollment []. Caregiver decision-making is therefore one important, but not exclusive, determinant of participation. Few studies have directly examined how parental decision-making processes relate to withdrawal or early termination in POCTs more broadly. However, an analysis of the Children’s Oncology Group (COG) AALL932 trial reported that, although accrual goals for the POCT were met, withdrawal was relatively high, with 22% of children nationally and 40% of children at one institution withdrawn due to “parental choice” []. These rates are similar to the national average on other COG trials, which are typically late-phase POCTs [, ]. Although limited data is available regarding withdrawal from early-phase trials, the greater uncertainty about benefits and poorer overall survival expectations in early-phase POCTs raise the concern that withdrawal rates may be even higher in this context. The authors noted that parents’ reasons for withdrawing were not well understood [], highlighting a critical knowledge gap. Furthermore, Aristizabal et al., 2021 evidenced that higher decisional regret was associated with a lower perception of having made a voluntary decision regarding POCT enrollment [] suggesting that parental psychosocial and decisional factors may be key to understanding why some families later choose to withdraw their child from a POCT. Caregivers considering POCT participation must make high-stakes decisions shortly after a life-altering diagnosis, often while experiencing intense emotional distress, uncertainty, and cognitive overload [, ]. Evidence suggests that emotional burden directly shapes decision-making processes [] and POCT decision-making requires understanding complex scientific information during a time of profound distress []. Although psychosocial factors such as stress, comprehension, trust, and social context are known to influence decision-making in various populations [–], the field of POCTs lacks an integrated framework that highlights how these psychosocial factors intersect with decision-making patterns to shape POCT participation. In this commentary, we do not seek to present a finalized, empirically validated framework, but rather to offer an outline of a conceptual model and associated hypotheses to guide future empirical work. Specifically, this commentary aims to (a) articulate the rationale for a precision communication approach in POCTs, (b) propose preliminary hypotheses regarding psychosocial-decisional profiles and their potential implications for communication priorities, and (c) delineate next steps for empirical work needed to define, operationalize, and validate the framework. The outline of the conceptual model we propose is intended to be adaptable across trial phases (e.g., early- and late-phase POCTs) and age groups (children and adolescents/young adults), while recognizing that goals of care, decisional priorities, and the tempo and structure of informed-consent discussions may differ across these contexts.