Abstract
INTRODUCTION: Clinical trials are being conducted and are being planned to assess the safety and efficacy of multi-cancer early detection (MCED) tests for use in cancer screening. This study aimed to determine the feasibility of primary care patient outreach in recruiting participants to a planned MCED clinical trial, assess patient interest in trial participation, and measure decisional conflict related to participation. METHODS: The research team used the electronic medical record of a large, urban health care system to identify primary care patients 50-80 years of age who were potentially eligible for a planned MCED trial. We mailed information about the planned MCED trial to identified patients and then contacted the patients by telephone to obtain consent and administer a baseline survey. Subsequently, we contacted consented patients to complete an interview to review the mailed information and elicit perceptions about trial participation. Finally, a research coordinator administered an endpoint telephone survey to assess patient interest in and decisional conflict related to joining the trial. RESULTS: We randomly identified 1000 eligible patients and were able to make contact with 690 (69%) by telephone. Of the patients contacted, 217 (31%) completed the decision counseling session and 219 (32%) completed the endpoint survey. Among endpoint survey respondents, 177 (81%) expressed interest in joining the MCED trial and 162 (74%) reported low decisional conflict. CONCLUSIONS: Most patients were contacted and about a quarter of those contacted expressed interest in and low decisional conflict about joining the planned MCED trial. Research is needed to determine how to optimize patient outreach and engage patients in shared decision-making about MCED trial participation.