Planning grant to support a future trial of an intervention to improve clinical trial education and enrollment

About This Grant

PROJECT SUMMARY/ABSTRACT Cancer patient participation in therapeutic clinical trials is essential to the development and evaluation of new cancer treatments to improve patient survival, outcomes, and quality of life. However, investigators and institutions often fail to recruit the number of patients required to answer the study’s question or provide generalizable results, limiting the advancement of cancer care. Trial enrollment rates among U.S. cancer patients remain persistently low. It is estimated that 77% of US cancer patients are not enrolled to trials due to being treated at sites with no trial options for them. Of the remaining 23% of all patients treated at facilities with available trials, only 8%, or just over 1 in 3, are enrolled. Rural areas are characterized by uneven and insufficient accrual of patients onto therapeutic clinical trials. Current solutions to supporting clinical trial enrollment include big data initiatives, such as precision oncology protocols, designed to reduce structural barriers by matching patients to trial opportunities within large clinical trial networks. Patient decision aids administered at the time of invitation to a specific trial are designed to help patient better understand and make informed decisions about joining trials . Despite the proliferation of these efforts, their efficacy in increasing trial enrollment is inconsistent and trial enrollment rates remain stagnant. Research from our group and others has shown that patients’ trial enrollment decisions are not just based on their views of a specific trial opportunity but also factors such as misunderstanding, mistrust, negative attitudes, and poor communication skills which can limit patients’ participation in clinical trial conversations and decision making. Our premise is that interventions are needed to extend beyond prevailing strategies of offering decision aids or education at the time of trial invitation to also proactively preparing patients to have meaningful conversations and make informed decisions if presented with a trial opportunity. We have developed and experimentally tested a set of evidence-based message strategies, grounded in health communication principles and behavior change theories, which can be effective at improving patient understanding and communication skills, even among those with mistrust or negative attitudes toward research. We propose to assemble these evidence-based components into an interactive, game-based educational intervention to prepare patients to engage in clinical trial conversations and informed decision-making if an opportunity to join a trial emerges during their treatment. The planning studies in this R34 application are designed to support a future trial by completing these Specific Aims: 1) to apply user-centered design and iterative development methods to produce an intervention that integrates evidence-based messaging strategies into a game package ; 2) to conduct a pilot study of the intervention in the field; and 3) to collect prospective data from medical records and self-report patient survey related to clinical trials.