Prospective, Multicenter Study to Assess the Effect of the Speaking Book on Patients’ Understanding of Clinical Research Knowledge: The SOUND Study

Introduction: Communicating complex clinical trial information to potential participants with varying literacy levels and health conditions can be challenging. Ensuring health equity and promoting clinical trial diversity requires building trust with patients from diverse sociocultural backgrounds, particularly those with low literacy levels. Exploring new communication strategies such as interactive audio-visual formats in their native language can improve participants’ understanding of, and participation in, clinical trials, particularly when it is tailored to their literacy levels. The “Speaking Book (SB)” is a customizable, audio-visual tool that explains in a simplified language what it means to be part of a clinical trial to improve participants’ understanding of clinical trials. It offers an interactive and engaging way to educate patients with low literacy levels, providing essential clinical trial information. This tool can be beneficial particularly in underserved communities, making learning about clinical research accessible and equitable for all. To determine the impact of the SB on participants' understanding of clinical trials, a non-interventional study is being conducted in Ghana, Kenya, and India. This study aims to determine whether SBs can significantly enhance the understanding of clinical trials among clinical trial–naive participants or those with limited knowledge on clinical research, especially among those with low literacy levels.

Methods: This prospective, multicenter, qualitative research study included clinical trial–naive adult patients with benign hematological disorders with low literacy levels. Participants who are unable to understand or unwilling to sign an informed consent form and those with conditions that could hinder study completion such as psychiatric illnesses, visual or cognitive impairments, memory issues, or active substance addiction, were excluded. The primary objective is to evaluate the improvement in clinical trial knowledge among participants when using the SB. The secondary objectives are to assess the willingness to participate in a clinical trial and evaluate the ease of use and meaningfulness of the SB. The study plans to enroll 205 participants randomized (1:1) to either the control group (participants will receive standard education about clinical trials from their clinic team) or the review group (participants will receive both standard education and SBs). There are 2 study visits: visit 1 at baseline and visit 2 after 1 month (± 2 weeks). At both visits, all participants will complete the Clinical Trial Knowledge Questionnaire (CTKQ) to measure their knowledge of clinical trials. At visit 2, all participants will also complete the Knowledge Impact Questionnaire (KIQ) to measure their willingness to participate in clinical trials. The review group will additionally complete the Speaking Book Ease of use Questionnaire (SBEQ) to measure their satisfaction with the SB. The visit 2 questionnaires will be virtually administered by an independent interpreter or through telephone at the center. The primary endpoint will be the difference in clinical trial knowledge scores between the control and review groups at visit 2. The secondary endpoints are the difference in willingness to participate score, the descriptive assessment of the ease of use of the SB, and the descriptive assessment of patient demographics and/or center type impact on the utility of the SB.

Results: The study follow-up is completed in Ghana, with enrollment and follow-up ongoing in Kenya and India. To date, 190 participants out of 205 planned have been enrolled. Data analysis and clinical study report will be finalized subsequently for presentation and/or publication.

Conclusions: The study rationale and objectives are based on the hypothesis that the Speaking Books can significantly increase knowledge of clinical trials among research-naive patients with no or little clinical research knowledge, particularly those with low literacy levels in underserved communities. We anticipate that such practical and immersive approach will help build trust and embrace the inclusion of more diverse patients in clinical trials.