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Evaluation of Factors Affecting Awareness of and Willingness to Participate in Cancer Clinical Trials

From the University of California Davis Cancer Center; The Center for Health Services Research in Primary Care, UC Davis Medical Center, Sacramento; the Cancer Information Service/Northern California Cancer Center, Fremont; Association of Northern California Oncologists, San Rafael; and the Veterans' Administration of Northern California, Martinez, and Mather AFB, CA

Address reprint requests to Primo N. Lara Jr, MD, University of California Davis Cancer Center, 4501 X St, Suite 3016, Sacramento, CA 95817; e-mail: primo.lara{at}ucdmc.ucdavis.edu

PURPOSE: Annually, only 3% of patients participate in cancer clinical trials (CCTs). Barriers to accrual include lack of CCT awareness and uncertain third-party payer coverage. In January 2002, a California law (Senate Bill 37 [SB37]) required all third-party payers to reimburse patient care costs related to CCTs. We evaluated the level of awareness of patients and/or their family members/friends regarding CCTs and SB37.

METHODS: We used both a written survey for patients and/or their family members and friends seen in oncology clinics, and a verbal telephone version for Cancer Information Service callers. We tested for correlations between CCT awareness and SB37 knowledge, and willingness to participate in CCTs.

RESULTS: Of 1,188 respondents, 59% were aware of CCTs, 19% knew of SB37, and 36% were very likely to consider a CCT. There were significant positive correlations between CCT awareness and willingness to participate (P < .001, Spearman), and between SB37 knowledge and willingness to participate (P = .001, Pearson ²). Reduced awareness was seen in respondents who were either black or African American (odds ratio [OR], 0.44; P = .004), Hispanic (OR, 0.56; P = .03), had an annual income less than $25,000 (OR, 0.38; P < .001), or had less than a college degree (OR, 0.12 to 0.53; P < .001 to .013). Reduced willingness to participate in CCTs was seen in black or African American participants (OR, 0.38; P < .001), Asians (OR, 0.44; P < .006), or respondents aged 18 to 24 years (OR, 0.35; P = .002).

CONCLUSION: These results support the hypothesis that improving CCT awareness and SB37 knowledge especially among lower income, less educated, and minority patients, may potentially overcome barriers to participation and subsequently increase accrual in California.

Supported by the National Cancer Institute (Grant R21 CA-03-501), ACS-CRTG#19701CCE (P.N.L.), and the Veterans Administration of Northern California.

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

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