Overcoming barriers to cancer clinical trial accrual: impact of a mass media campaign.

BACKGROUND: Annually, only 3% of adult patients participate in cancer clinical trials (CCT). Accrual barriers include lack of CCT awareness and uncertain third-party coverage. In 2002, a California law (SB37) required all insurers to reimburse costs related to CCT. The objective of the current study was to increase awareness of CCT and SB37 through a mass multimedia campaign (MMC) in the University of California (UC) Davis (UCD) Cancer Center catchment area. The authors assessed willingness to participate in and accrual to CCT. METHODS: Changes in CCT/SB37 awareness and willingness to participate were investigated before the MMC versus after the MMC and in UCD respondents versus UC San Diego (UCSD) catchment respondents-a control group that was not exposed to the MMC-by Pearson chi-square and logistic regression analyses. RESULTS: Of 1081 post-MMC respondents, 957 were from UCD, and 124 from UCSD. UCD respondents had a greater awareness of CCT (59% vs 65%; P < .01) and SB37 (17% vs 32%; P < .01) compared with UCSD respondents. Willingness to participate did not change in either cohort. Awareness level predicted willingness (odds ratio, 2.3; P < .01). Blacks, Asians, and lowest income (<$25 K per year) groups were the least willing to participate (P < .01, P < .04, and P < .02, respectively). The CCT accrual rate at UCD was unchanged. CONCLUSIONS: CCT and SB37 awareness increased significantly in the UCD cohort after the MMC. However, it was unclear whether this increase was attributable entirely to the MMC or to varying demographic variables. Enhancing patient willingness and accrual will require targeting other variables, such as physician or resource barriers, rather than just CCT and reimbursement awareness.

Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials.

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 chi2). 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 dollars (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.

Asian Americans and cancer clinical trials: a mixed-methods approach to understanding awareness and experience.

Cancer clinical trials have been based on low accrual rates. Barriers to recruitment of minority populations affect the generalizability and impact of trial findings for those populations. The authors undertook a mixed-methods approach to understanding levels of awareness and experiences with cancer clinical trials. A survey was administered to new cancer patients and their caretakers (family, close friends, or other social support) at outpatient oncology clinics. Field observations of the trial accrual process also were conducted by employing the grounded theory approach in qualitative methods. Comparison of survey results for Asian-American respondents and non-Asian respondents indicated that Asians were less likely to have heard the term "clinical trial" and were more likely to define a clinical trial as "an experiment" or "a test procedure in a clinic" than non-Asians. Asians were more likely to have employer-based insurance and to report understanding issues related to cost reimbursement. Asians were less likely to have been involved in or to know someone in a trial and reported less willingness than white respondents to consider trial participation. Qualitative observations suggested that Asians who presented for a potential trial were interested in the availability of a novel cancer therapy but were not eligible for available trials. Multiple strategies will be necessary to enhance awareness of and experience with accrual to cancer clinical trials for Asians, including richer understanding and increased involvement of Asians in cancer clinical trials and greater attention to the location and diversity of the Asian population in structuring study centers and evaluating trial results.