Theory-guided assessment of barriers and facilitators to adequate informed consent for childhood cancer clinical trials: Using the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.

Abstract

6539 Background: To participate in childhood cancer clinical trials, parents/legal guardians must provide informed consent (IC), which is a fundamental ethical right. However, barriers to achieving valid IC include: use of medical jargon, misunderstanding about clinical trials procedures, tremendous emotional distress surrounding the initial cancer diagnosis, and the complexity and length of the IC forms. There are scarce data on using theory to assess perspectives of parents of children with cancer on barriers and facilitators for adequate IC in diverse populations. Methods: Using implementation science theory and methods, we assessed parent-reported barriers and facilitators to adequate IC, in a convenience sample that included a significant number of Hispanics. Twelve qualitative semi-structured interviews and 224 open-ended surveys were conducted with 236 parents of children with newly-diagnosed cancer at Rady Children’s Hospital-San Diego, a large quaternary children’s hospital in California. Fifty-three percent of participants were Hispanic and 38% were monolingual Spanish-speakers. We utilized the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework, specifically domains of outer context, inner context, bridging and innovation factors. Four main codes (IC concepts and delivery; desired clinical trial information; motivations and emotions related to clinical trial enrollment; and potential areas for interventions) were used as a coding guide for analysis. Interviews and surveys were transcribed and coded for thematic analysis by three independent coders to identify key barriers and facilitators. Results: Four main themes were identified as barriers: 1) Complexity of the IC forms and discussion (lengthy, confusing, not available in Spanish, and use of medical jargon); 2) parents feeling emotionally overwhelmed, anxious and pressured around the IC; 3) parents viewing the clinical trial as the only treatment option; and 4) mistrust and fear of clinical trial procedures. Four IC facilitators were identified: 1) simpler explanations of study procedures; 2) provider flexibility for accommodations when delivering the IC, including psychosocial support; 3) active promotion of voluntariness and trust; and 4) supplemental education in lay language, including request for peer-education, decision aids, and navigation to “bridge the provider-patient gap.” Conclusions: Our implementation science approach identified multiple barriers and facilitators to adequate IC in a diverse sample of parents. Findings can inform potential interventions to enhance IC for childhood cancer clinical trials, including the use of decision aids, peer-navigation, and interventions tailored to the language and culture of the individual.