Abstract P6-05-22: Multilevel, Multicomponent Intervention to Improve Informed Decision-Making about Clinical Trial Participation among Cancer Patients
Authors: Chalela Patricia , Cortez Vivian , Flores Armida , Sivak Sandra , Lew Ysabel , Munoz Edgar , Despres Cliff , Rainosek Callie , Gonzalez Alyssa , Ali Amara , Mesa Ruben , Ramirez Amelie 
Published: March 2023

Abstract
Background: Knowledge gained through cancer clinical trials (CTs) has been proven critical to preventing, diagnosing and treating the disease, and providing the evidence base for clinical practice. Major advances in cancer treatment, which are essential for improving patients’ outcomes, come from investigations of new therapeutic agents in CTs. Despite the large number of available studies and improvements in public awareness about CTs, participation of underrepresented minorities in clinical research has been persistently low, with only 2 to 5% of Latinos and African Americans participating in cancer treatment trials. Barriers to participation are multilevel, complex, and multifactorial, including study design, healthcare system barriers, and patient- and medical team-related factors. Structural inequities, social determinants of health, distrust of government, patient-doctor communication, cultural and language barriers, and lower levels of health literacy have all been cited as common barriers for Latino and African American populations. Purpose: To improve informed decision-making about cancer CT participation among cancer patients and community members through a bilingual multilevel, multi-communication approach, including 1) a randomized controlled educational trial (clinic-based settings), and 2) a community education module (community-based settings). We will assess the impact of the intervention on awareness, attitudes, self-efficacy, and intentions to consider CTs as an appropriate treatment option for cancer and improve CT participation rates. Methods: The clinical setting includes a 2-group, parallel, randomized study with 400 patients from the Mays Cancer Center. The intervention group receives 1) a bilingual educational video on CTs, 2) a low literacy booklet, 3) support from a patient navigator (PN), and 4) an invitation to join our Salud America! network providing online/social media CT information. The control group receives a general fact sheet on CTs. All healthcare providers involved in clinical research will participate in Webinars to raise awareness of implicit bias and the importance of inclusive research. The community-setting intervention features a prospective single-group pre/post design, where participants (400) act as their own controls. They will receive an educational session on CTs provided by a community health educator + a low literacy booklet. Results: Focus groups guided the development of the video script, booklet, and educational materials. The short video features real cancer patients sharing their experience with CTs and how they overcame common barriers. Patient recruitment starts in August 2022. Preliminary results will be presented. Conclusions: Multilevel interventions involving culturally tailored decision aids (i.e., online video, low literacy booklet) in combination with care coordination by a PN can effectively address common barriers influencing patient decision-making regarding CTs, raise awareness, and increase positive attitudes and CT participation among specific groups with low participation in clinical research. Keywords: health equity, clinical trials, Latinos, underrepresented groups
Citation Format: Patricia Chalela, Vivian Cortez, Armida Flores, Sandra Sivak, Ysabel Lew, Edgar Munoz, Cliff Despres, Callie Rainosek, Alyssa Gonzalez, Amara Ali, Ruben Mesa, Amelie Ramirez. Multilevel, Multicomponent Intervention to Improve Informed Decision-Making about Clinical Trial Participation among Cancer Patients [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-22.