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Unpacking clinical trial offers: A qualitative analysis of interactions with physicians and patients potentially eligible for a prostate cancer trial.

e23169 Background: Clinical trial accrual among cancer patients is low (2-5%). More data are needed to identify barriers to enrollment and inform interventions. One way to identify the greatest barriers is by examining clinical interactions. We investigated whether and under what circumstances patients potentially eligible for a trial at a major cancer center were offered the chance to enroll. Methods: We conducted a qualitative content analysis of 50 recorded interactions with physicians (n = 8) and patients (n = 36) with intermediate- or high-risk prostate cancer who were initially eligible for a trial at two NCI-designated comprehensive cancer centers. We observed and coded the interactions in three steps: 1) classification of all interactions as explicit offer, offer pending, trial discussed but not offered, or trial not discussed; 2) in interactions with no explicit offer, classification of patients who were informed their disease was stable or had progressed; 3) in interactions classified as cancer progressed but no trial offered, identification of factors discussed that may explain the lack of an offer. Results: Of the 50 interactions, 30% were classified as explicit offer; 6% as offer pending; 18% as trial discussed but not offered; and 40% as trial not discussed. Of the 35 interactions with no offer, 54% were with patients whose cancer had not progressed. In the 16 remaining interactions with patients with no offer and whose cancer had progressed, reasons for the lack of offer included: testing needed, no trial/study slot, and comorbidities; but in 25% of these, no reason was provided. Conclusions: Even in this highly selected population, few patients were offered a trial, often because they were ultimately ineligible. Findings support professional recommendations to broaden inclusion criteria to increase the pool of eligible patients. Findings also suggest trial accrual rates could be more accurately calculated by considering patients who are eligible to enroll, rather than all patients with cancer. In 40% of interactions, there was no mention of a trial, suggesting interventions should also be aimed at patient and physician attitudes and clinical communication. Clinical trial information: NCT 02906241.