Corinne Turrell

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.

Overcoming Barriers to Cancer Clinical Trial Accrual : Impact of a Mass Media Campaign

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.

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. Cancer 2005. Published 2005 by the American Cancer Society.

High-dose toremifene as a cisplatin modulator in metastatic non-small cell lung cancer: targeted plasma levels are achievable clinically

Purpose: The triphenylethylenes tamoxifen and toremifene have been reported to enhance the cytotoxicity of cisplatin by inhibition of protein kinase C (PKC) signal transduction pathways. However, the concentrations of tamoxifen and toremifene required for chemosensitization in preclinical models are generally ≥5 μM, at least tenfold higher than plasma levels observed in patients receiving these agents as antiestrogenic therapy. As part of a translational phase II trial investigating the efficacy and potential molecular mechanism of high-dose toremifene as a cisplatin modulator in metastatic non-small-cell lung cancer, plasma concentrations of toremifene and its active metabolite N-desmethyltoremifene were measured to determine whether targeted levels could be achieved clinically. Methods: Treatment consisted of toremifene, 600 mg orally on days 1–7, and cisplatin, 50 mg/m2 intravenously on days 4 and 11, repeated every 28 days. Toremifene and N-desmethyltoremifene were measured by reverse-phase HPLC assay on days 4 and 11 prior to cisplatin infusion. Results: In the initial 14 patients, the mean total plasma concentrations of toremifene plus its N-desmethyl metabolite on days 4 and 11 were 14.04 (±8.6) μM and 9.8 (±4.4) μM, respectively. Variability in concentrations achieved did not correlate with renal or hepatic function, gender, or body surface area. Levels of N-desmethyltoremifene were higher on day 11 relative to toremifene concentrations. Conclusions: We conclude that plasma levels achieved compare favorably with the levels required for cisplatin chemosensitization and PKC modulation in vitro. Targeted toremifene levels can be achieved clinically with 600 mg orally daily in combination with cisplatin and are well tolerated.

Understanding Asian American awareness of and experience with cancer clinical trials (CCTs): A mixed methods approach

6052 Background: Barriers to recruitment of minority populations affect generalizability, impact, and use of CCT findings for those populations. Methods: We undertook a mixed-methods approach to understand awareness of and experiences with CCTs. A self-administered survey using convenience sampling was provided in English to new cancer patients and their support persons at outpatient oncology clinics within a 9-county area of an NCI-designated cancer center. Observations of accrual processes to CCTs were conducted using the grounded theory approach. Results: 1006 surveys were completed and 59 unique patients observed. Comparison of survey results for Asian and non-Asian respondents showed Asians less likely to have heard the term “clinical trial” (59% Asian versus 69% all others) and more likely to define a clinical trial as “an experiment” or “a test procedure in a clinic” (n=45, 75%) than Whites (n=570, 61%) or persons of other ethnicities (n=107, 60%). Asians were more likely to have employer-based ins...