Patient attributes and information provided about clinical trials

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Patient Attributes and Information Provided about Clinical Trials
 Minority group members and individuals of lower socioeconomic status (SES) are underrepresented in cancer clinical trials. Some researchers have proposed that this under representation reflects distrust of medical research involving minorities. However, little is known about how minority and lower SES patients are actually treated during offers to participate in clinical trials. The purpose of this study was to examine if there are differences in the amount of information physicians provide to majority and minority patients when they offer clinical trials. Using video-recorded oncology interactions, we examined how patient race, other demographic characteristics (income, education), situational variables (presence/absence of a companion), and physician experience with clinical trials were related to amount of information physicians provided during offers of clinical trials. Patients’ attitudes toward the trials were also examined.
 Patients and physicians at two regional cancer centers, participating in a larger study on oncologist-patient communication, consented to be video-recorded while they interacted. Trained observers reviewed recordings of 235 interactions and identified 42 that included an explicit offer to participate in a clinical trial. Independent raters observed these recordings and using a previously validated checklist recorded: a) number and kind of legal/informational messages about trials (e.g., “Participation is voluntary.”); and b) number and kinds of potential side effects given/mentioned by physicians. Dependent measures were total amount of each kind of information (i.e. legal/informational messages and side-effects), and patients’ attitudes towards the trials (assessed in post-visit interviews).
 In 13 of 42 interactions (31%), physicians gave no information about side effects. Significant differences were found between patients who were and were not given any information about side effects. Relative to patients given some information, patients given no information about side effects were more likely to be Black, less educated, and more likely to be seen by physicians with fewer patients on other trial protocols. Patient race was still a significant predictor of whether information on side effects was given when education and physician experience were controlled in a logistic regression. Patients given no information about side effects were also significantly more likely not to have a companion present during the interaction than patients given information. Blacks were significantly less likely to have a companion than Whites; controlling for companion presence/absence eliminated effects of race on information given about side effects. The same pattern of significant relationships was found for total amount of information given. Finally, in post-visit interviews, Blacks expressed “second thoughts” about participating in the clinical trial to a significantly greater extent than Whites.
 Results suggest that minorities and socially disadvantaged individuals may receive significantly less information during clinical trial offers than more advantaged individuals. Thus, concerns about including such individuals in clinical trials need to extend beyond simply increasing their representation in such trials and address the interactions in which offers are made.