M. Chen1, N. Reh1, S.R. Dwarampudi3, N. Henderson2, C. Williams4, G.B. Rocque5, L.A. Gutnik6 1University Of Alabama at Birmingham, Heersink School Of Medicine, Birmingham, Alabama, USA 2University Of Alabama at Birmingham, Department Of Medicine, Division Of Hematology And Oncology, Birmingham, Alabama, USA 3Medical College Of Georgia, Augusta University, Augusta, GA, USA 4University Of Alabama at Birmingham, Department Of Medicine, Division Of Preventative Medicine, Birmingham, Alabama, USA 5University Of Alabama at Birmingham, Department Of Hematology And Oncology, O’Neal Comprehensive Cancer Center, Birmingham, Alabama, USA 6University Of Alabama at Birmingham, Department Of Surgery, Birmingham, Alabama, USA
Introduction: Less than one in ten patients with cancer participate in clinical trials due to health system-, trial-, provider-, and patient-level factors. This study aimed to understand potential barriers and facilitators to clinical trial enrollment among women with breast cancer who declined trial enrollment.
Methods: This is a cross-sectional qualitative study at a NCI-designated comprehensive cancer center in the Deep South. Semi-structured interviews elucidated barriers and facilitators to clinical trial enrollment in women with breast cancer who were eligible for, yet declined enrollment onto a clinical trial. Interviews were recorded, transcribed, and coded using a content analysis approach by two independent reviewers, and a third reviewer settled any discrepancies.
Results: Of 21 patients interviewed, 9 had previously declined enrollment onto a therapeutic clinical trial and 12 a non-therapeutic clinical trial. Patients were an average of 57 years old (SD=12), 43% (n=9) were Black, 33% (n=7) lived in a highly disadvantaged neighborhood, and 19% (n=4) were Medicaid enrollees. Over half (52%, n=11) of patients had previously participated in a clinical trial, while 43% (n=9) had never participated in a trial, and 6% (n=1) did not report previous trial enrollment. Concerns of trial impact on health were cited by 60% of patients, financial concerns were cited by 61% of patients, and the effort required by trials was cited by 48% of patients. Altruism as a motivation for trial participation was cited by 81% of patients, the hope of treatment was cited by 57% of patients, and connections to medicine were cited by 52% of patients. Travel, concerns of potential unknown side effect of trial therapeutics, and time commitment or effort required of the trial were key barriers to trial participation. Other identified barriers to trial participation included fear of experimentation, worries of randomization and not recieving treatment, and poor timing of the trial in relation to their diagnosis and treatment. The greatest facilitators to trial participation were the hope that trial therapeutics would improve the patient condition, as well as altruism to help future patients by contributing to research. Other facilitators on trial participation included: low risk vs benefit situation of a clinical trial, coverage of medical care through trial, a connection to the medical community, perception of better care in clinical trials, and trust in provider recommendation.
Conclusions: Though motivated by desire to improve cancer outcomes for themselves and others, patients also cited numerous barriers to clinical trial participation. Our findings can grant greater insight on where to design and test interventions to aid patients in their decision to participate in clinical trials, ultimately leading to improved and more equitable cancer outcomes for all patients.