Background: African-American patients have been under-represented in oncology clinical trials. Better understanding barriers to African-American participation may help increase the accrual of African-American patients onto clinical trials.

Methods: Two hundred eighteen patients with malignant disease (72 African-American patients and 146 white patients) were recruited from the Duke Cancer Clinic and from Duke Oncology Outreach Clinics (DOORS). Patients were interviewed using a standardized survey. Questions included patients' knowledge of cancer, religious/spiritual beliefs, satisfaction with medical care, knowledge of clinical trials, reasons for participating or refusing to participate in a clinical trial, financial/transportation issues, and demographic factors, such as age and education. Data on attitudes and belief were analyzed for group differences between African-American patients and white patients as well as between patients who were treated at the Duke Cancer Clinic and patients who were treated at DOORS clinics.

Results: Willingness to participate in a clinical trial depended on both race and clinic site. Forty-five percent of white patients, compared with 31% of African-American patients, were willing to participate in a clinical trial (P = 0.05). white and African-American patients who were treated at the Duke Cancer Clinic were more willing to participate in a trial compared with their counterparts who were treated at DOORS clinics (47% vs. 37%, respectively; P = 0.09). The greatest differences between groups (African-American patients vs. white patients and Duke Cancer Clinic patients vs. DOORS patients) were education and income: Much greater percentages of African-American patients and DOORS patients did not complete high school and had annual incomes < $15,000. In addition, more African-American patients than white patients believed that God would determine whether they would be cured or would die from their disease. In a multivariate analysis, education, income, and belief that God would determine the patient's outcome also were correlated with a decreased willingness to participate in clinical trials.

Conclusions: Factors associated with religion, education, and income, rather than race, may be major barriers to clinical trial participation. Interventions that target education and income may increase the recruitment of African-American oncology patients onto clinical trials.