The influence of race on the attitudes of radiation oncology patients towards clinical trial enrollment.

OBJECTIVES: Enrollment of adult cancer patients in clinical trials remains low, particularly in the minority population. Understanding patient attitudes towards clinical trials during the recruitment process may enhance accrual. Unfortunately, data describing patient attitudes towards clinical trials are limited, particularly in the radiation oncology clinic setting. METHODS: A piloted questionnaire assessing basic demographics and attitudes toward clinical trials was offered in 2 radiation oncology clinics between April 2003 and October 2003. The questionnaire was completed by 166 patients. The mean age of the patients completing the questionnaire was 56 years (range, 15-84 years). Of the 166 patients included in the analysis, 108 (65%) were White. The most common cancer diagnoses included prostate (19%), head and neck (16%), and breast (14%). RESULTS: There was no statistical difference between Whites and non-Whites regarding their interest in learning about clinical trials (84.3% versus 84.9%, P = 0.92); nor was there a significant difference in the rate of previous or current trial enrollment (21.3% versus 34.0%, P = 0.08). White patients were more likely to gather information about clinical trials from the Internet (30.6% versus 11.3%, P = 0.007), and they were more likely to use physicians as a source of this information (50.0% versus 34.0%, P = 0.05). Non-White patients were more likely to obtain information about clinical trials from other patients (24.5% versus 12.0%, P = 0.04). In addition, more non-White patients believed they had been treated on clinical trials without their knowledge (21.6% versus 9.3%, P = 0.032). Patients differed somewhat in their expectations of clinical trials. More non-Whites indicated that they would need a >50% chance of benefiting from a trial (64.4% versus 45.0%, P = 0.03) to enroll on that trial, though there were no statistical differences in outlook towards potential toxicities associated with treatment on a clinical trial. CONCLUSIONS: Minority patients historically enroll in clinical trials at a significantly lower rate. Our study of radiation oncology patients documents significant differences in attitudes towards clinical trials between Whites and non-Whites. Understanding the differences in attitudes may allow physicians to overcome barriers that would otherwise hinder the enrollment of non-White patients into clinical trials.

Breast cancer patients' attitudes toward clinical trials in the radiation oncology clinic versus those searching for trial information on the Internet.

Web-based clinical trials matching systems including breast cancer patients are expanding rapidly. However, limited data exist regarding the demographics and attitudes of breast cancer patients using the Internet to search for clinical trials information. Biases in patient populations could be introduced by recruiting patients to trials through the Internet. This study was designed to compare breast cancer patients in the radiation oncology clinic to those using the Internet to search for clinical trials information. A piloted questionnaire assessing demographics and attitudes regarding clinical trials was offered through the radiation oncology clinic at the University of Pennsylvania and on the OncoLink website (http://www.oncolink.org). The questionnaire consisted of 18 questions and was answered by a total of 157 patients with breast cancer. Breast cancer patients using the Web were more likely to be interested in clinical trials testing new drugs or therapies (71 [53%] versus 4 [17%], p = 0.002). More clinic patients indicated they would need a greater than 50% chance of benefiting from a trial (12 [52%] versus 33 [25%], p = 0.01) and a less than 10% potential for serious toxicity from a trial (15 [65%] versus 51 [38%], p = 0.02) for consideration of enrollment. African Americans were more likely than other races to have never used the Internet to search for cancer-related information (4 [40%] versus 18 [12%], p = 0.01), more likely to indicate that they need a greater than 50% chance of benefit to enroll in clinical trials (8 [80%] versus 37 [25%], p = 0.001), and less likely to be interested in clinical trials testing new drugs or therapies (1 [10%] versus 73 [50%], p = 0.01). Breast cancer patients have different attitudes regarding clinical trials based on race, Internet usage, and previous trial enrollment. Biases may be introduced with recruitment for clinical trials through the Internet. Radiation oncologists must consider these issues when offering clinical trials information through the Internet.

Clinical trial resources on the internet must be designed to reach underrepresented minorities.

PURPOSE: Internet-based clinical trial information services are being developed to increase recruitment to studies. However, there are limited data that evaluate their ability to reach elderly and underrepresented minority populations. This study was designed to evaluate the ability of an established clinical trials registry to reach these populations based on expected Internet use. PATIENTS AND METHODS: This study compares general Internet users to participants who enrolled in an Internet based colorectal cancer clinical trials registry established by OncoLink (www.oncolink.org) and the National Colorectal Cancer Research Alliance. Observed rates of demographic groupings were compared to those established for general Internet users. RESULTS: Two thousand, four hundred and thirty-seven participants from the continental United States used the Internet to register for the database. New England, the Mid-Atlantic region, and the Southeast had the highest relative frequency of participation in the database, whereas the Upper Midwest, California, and the South had the lowest rates. Compared to general Internet users, there was an overrepresentation of women (73% vs. 50%) and participants over 55 years old (27% vs. 14%). However, there was an underrepresentation of minorities (10.3% vs. 22%), particularly African Americans (3.1% vs. 8%) and Hispanics (2.8% vs. 9%). DISCUSSION: The Internet is a growing medium for registry into clinical trials databases. However, even taking into account the selection bias of Internet accessibility, there are still widely disparate demographics between general Internet users and those registering for clinical trials, particularly the underrepresentation of minorities. Internet-based educational and recruitment services for clinical trials must be designed to reach these underrepresented minorities to avoid selection biases in future clinical trials.

Gene expression signature predicts lymphatic metastasis in squamous cell carcinoma of the oral cavity.

Metastasis via the lymphatics is a major risk factor in squamous cell carcinoma of the oral cavity (OSCC). We sought to determine whether the presence of metastasis in the regional lymph node could be predicted by a gene expression signature of the primary tumor. A total of 18 OSCCs were characterized for gene expression by hybridizing RNA to Affymetrix U133A gene chips. Genes with differential expression were identified using a permutation technique and verified by quantitative RT-PCR and immunohistochemistry. A predictive rule was built using a support vector machine, and the accuracy of the rule was evaluated using crossvalidation on the original data set and prediction of an independent set of four patients. Metastatic primary tumors could be differentiated from nonmetastatic primary tumors by a signature gene set of 116 genes. This signature gene set correctly predicted the four independent patients as well as associating five lymph node metastases from the original patient set with the metastatic primary tumor group. We concluded that lymph node metastasis could be predicted by gene expression profiles of primary oral cavity squamous cell carcinomas. The presence of a gene expression signature for lymph node metastasis indicates that clinical testing to assess risk for lymph node metastasis should be possible.