Background- Less than 5% of all adult cancer patients enter clinical trials. In the United States these rates are lower in African American populations, negatively affecting the generalizability and validity of trial results. Many studies have identified barriers to minority enrolment yet few studies have used rigorous qualitative methods to gain a comprehensive understanding of AA cancer patients’ trial refusal reasons. We aimed to a) explore trial refusal reasons in a sample of African American (AA) cancer patients who declined trial participation and b) gather patients’ perceptions of the potential benefit of an array of decision support tools.
Methods- Participants were 22 consecutively recruited AA cancer patients who had declined participation in a therapeutic clinical trial. Within three months of the trial refusal decision, participants completed an audio-recorded semi structured interview that asked about demographic/disease information, psychosocial factors and patients’ experience with clinical trials. Two months later participants completed a questionnaire that asked about their trial decision. Interview audio-recordings were transcribed in full. Transcriptions were analyzed using rigorous qualitative methods.
Results- Few patients received positive recommendations about joining a trial. Patients gave multiple refusal reasons. Only two participants refused to join a clinical trial due to issues of mistrust. Most participants refused due to fears of additional burdens and side effects. Many patients and family members misunderstood trial information. Family members mostly recommended against trial participation. Most patients felt that Question Prompt Lists or Decision Aids would assist information seeking and decision-making.
Conclusions- Low rates of physician recommendations warrant further investigation. It may be that these 22 patients were trial eligible but uninsured or on Medicaid. Thus, the treating institutions receive no reimbursement to cover trial treatments. Interventions to reduce misunderstandings and aid decision-making, both within and external to the clinical interaction, need to target both patients and family members.