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Enrolling Older Persons in Cancer Trials: The Effect of Sociodemographic, Protocol, and Recruitment Center Characteristics

From the Sections of General Internal Medicine and Cardiovascular Medicine; Department of Medicine, Robert Wood Johnson Clinical Scholars Program; Department of Epidemiology and Public Health; Yale University School of Medicine, New Haven, CT; and Flying Buttress Associates, Charlottesville, VA

Address reprint requests to Cary P. Gross, MD, Yale University School of Medicine, Primary Care Center, 333 Cedar St, PO Box 208025, New Haven, CT 06520; e-mail: cary.gross{at}yale.edu

PURPOSE: To determine the effect of patient, protocol, geographic, and institutional factors on enrollment of older persons onto cancer trials.

METHODS: We conducted a cross-sectional analysis of patients enrolled onto National Cancer Institute–sponsored lung, breast, colorectal, and prostate cancer trials during 1996 to 2002. We used a cross-classified logistic multilevel model to examine the associations between patient, hospital, county, and protocol characteristics, and the likelihood of participants being elderly ( 65 years old).

RESULTS: The final study sample consisted of 36,167 patients enrolled onto 33 trials. After accounting for cancer type, only 6% of the variation in elderly enrollment onto cancer trials was at the protocol level. In contrast, more than 55% of the variation in elderly enrollment was attributable to patient level variation. In multivariate analysis, nonwhite patients were significantly less likely to be elderly than whites (odds ratio [OR] for blacks, 0.51; 95% CI, 0.44 to 0.58; and OR for Hispanics, 0.49; 95% CI, 0.40 to 0.59 v whites). Participants living less than 7 miles from their recruitment center were significantly more likely to be elderly (OR, 1.31; 95% CI, 1.24 to 1.38). Among the 910 recruitment centers, the median adjusted proportion of patients who were elderly was 24.9% (interquartile range, 24.0% to 26.9%). There were a significantly higher number of outlier centers ( 20.8% or 29.3% elderly) than would be expected by a normal distribution (68 observed v six expected; P < .0001).

CONCLUSION: Race and proximity to trial enrollment centers were significantly related to age of trial participants after adjusting for protocol factors. Additional work should explore why some recruitment centers were outliers regarding enrollment of older persons.

Supported by a Cancer Prevention, Control and Population Sciences Career Development Award (1K07CA-90402), a Beeson Career Development Award (1 K08 AG24842), and the Claude D. Pepper Older Americans Independence Center at Yale (P30AG21342).

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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