Leveraging clinical pathways to identify patient-reported clinical trial enrollment barriers.

Abstract

e14086 Background: Only about 3% of adult cancer treatment is within a clinical trial (CT). Patient personal factors may impact willingness to participate. We leveraged CTs embedded in Clinical Oncology Pathways (COP) to examine patient barriers to CT participation. Methods: A COP program used in an academic cancer center embeds CTs that are open for accrual at the center. Providers must either select the CT to alert the research team for patient screening for the CT or provide a reason for bypassing the CT before the COP presents standard care options. This study includes patients with solid tumors receiving systemic therapy for whom a CT is presented in the COP and the provider documented that the patient was “not interested in this trial”. Prior to being offered the survey, these patients were asked if they had been interested in participating in a CT and were considered ineligible for the survey if they said “yes”. The survey was comprised of 29 Likert, demographic, multiple choice and open-ended questions. We categorized patients’ reasons for declining to enroll in a CT, and attitudes about CTs. Results: Among 1108 patients with CTs presented to the provider in COPs from May 2018 to June 2019 there were 164 identified by the provider as not interested in a CT. 23 were deceased, and 54 were not able to be contacted. 57 were otherwise ineligible. Of these, 33% did not recall being offered a CT. Of the 30 patients approached, 9 declined and 21 completed the survey (70% participation). Cancer types included gastrointestinal (33%), breast (19%), non-small cell (14%), pancreas (14%) and others (20%). 66% were female and 80% had metastatic cancer. Age ranged from 41 to 69 years (median 66). Race/ethnicity was Caucasian (81%), African American (10%), American Indian/Alaskan Native (5%) and non-specified (5%). When asked, “How do you view being asked to participate in cancer research, 76% saw it as “a positive thing”. Patient primary concerns were desire for more information on study outcomes (42%), concerns about additional appointments or tests (28%) and concerns about receiving a placebo (23%). Conclusions: There is a gap between patients’ positive views of clinical trials and their willingness to participate. This suggests that barriers identified are modifiable. Many who initially decline CTs may be open to joining a clinical trial with further education.Interventions such as the Meropol et al Preparatory Education About Clinical Trials (J Clin Oncol 2015:34:469) should be considered for broad implementation.