Impact of supplemental site grants to increase African American accrual for the Selenium and Vitamin E Cancer Prevention Trial
MD Anderson Cancer Center, University of Texas, Houston, TX 77230-1439, USA. Clinical Trials
(Impact Factor: 1.93).
02/2010; 7(1):90-9. DOI: 10.1177/1740774509357227
African American accrual to prevention trials at rates representative of the disease burden experienced by this population requires additional resources and focused efforts.
To describe the rationale, context, and criteria for selection of sites that received Minority Recruitment Enhancement Grants (MREGs) to increase African American recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). To determine if African American accrual was higher among the 15 MREG sites when compared with similar nonawarded sites.
Changes in African American accrual at sites that received MREGs are compared with changes in a group of 15, frequency-matched, nonawarded sites using a quasi-experimental, post hoc analysis. Successful and unsuccessful recruitment strategies reported by the MREG sites are described.
The increased number of African American participants accrued per month at MREG sites post-funding was higher than the change at comparison sites by a factor of 3.38 (p = 0.004, 95% CI: 1.51-7.57). An estimated 602 additional African American participants were recruited at MREG sites due to MREG funding, contributing to the overall 14.9% African American recruitment. Successful recruitment strategies most reported by MREG sites included increasing staff, transportation resources, recruiting through the media, mailings, and prostate cancer screening clinics during off-hours.
Comparison sites were chosen retrospectively, not by randomization. Although comparison sites were selected to be similar to MREG sites with regard to potential confounding factors, it is possible that unknown factors could have biased results. Cost-effective analyses were not conducted.
MREG sites increased African American accrual in the post-funding period more than comparison sites, indicating MREG funding enhanced the sites' abilities to accrue African American participants. Targeted grants early in the accrual period may be a useful multi-site intervention to increase African American accrual for a prevention study where adequate African American representation is essential.
Available from: Chirag Shah
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ABSTRACT: The authors reviewed changes in accrual to cancer clinical trials over the last 2 decades at their institution with a focus on minority participation after the implementation of a community clinical oncology program (CCOP) and an aggressive, education-orientated minority outreach program (MOP).
Data on patient enrollment in clinical trials for the years 1988 to 2010 was obtained from the William Beaumont Hospital (WBH) Cancer Clinical Trials Office. The type and number of cancers diagnosed and treated during the same period were obtained from the WBH tumor registry data. The MOP was initiated in the fall of 2003 with a focus on culture-specific cancer education.
With the development of the CCOP, clinical trials accrual increased significantly by 10-fold (P = .001). The primary service area for the CCOP consistently averaged an 85% to 90% Caucasian population. During the same period, the minority population for the service area remained stable between 8.8% and 10% and did not change significantly. From 1999 to 2004, the WBH tumor registry data demonstrated that minorities represented 8.6% of cancers registered, whereas the average yearly minority enrollment from 2002 to 2004 was 5.4%. After initiation of the MOP, minority accrual doubled to 11% by 2010 with stable minority demographics.
The current findings support the importance of a CCOP in supporting the accrual of patients to national clinical trials and increasing access to state-of-the art research. These data also strongly support focusing additional energy and educational efforts on targeting minority representation in clinical trials. Cancer 2011;. © 2011 American Cancer Society.
Cancer 03/2011; 117(20):4764-71. DOI:10.1002/cncr.26094 · 4.89 Impact Factor
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ABSTRACT: BACKGROUND: Recruitment of minorities to cancer prevention trials is difficult and costly. Early-phase cancer prevention trials have fewer resources to promote recruitment. Identifying cost-effective strategies that can replace or supplement traditional recruitment methods and improve minority accrual to small, early-phase cancer prevention trials are of critical importance. PURPOSE: To compare the costs of accrual strategies used in a small breast cancer prevention trial and assess their impact on recruitment and minority accrual. METHODS: A total of 1196 potential subjects with a known recruitment source contacted study coordinators about the SOY study, a breast cancer prevention trial. Recruitment strategies for this study included recruitment from within the Northwestern University network (internal strategy), advertisements placed on public transportation (Chicago Transit Authority (CTA)), health-related events, media (print/radio/television), and direct mail. Total recruitment strategy cost included the cost of study personnel and material costs calculated from itemized receipts. Incremental cost-effectiveness ratios (ICERs) were calculated to compare the relative cost-effectiveness of each recruitment strategy. If a strategy was more costly and less effective than its comparator, then that strategy was considered dominated. Scenarios that were not dominated were compared. The primary effectiveness measure was the number of consents. Separate ICERs were calculated using the number of minority consents as the effectiveness measure. RESULTS: The total cost of SOY study recruitment was US$164,585, which included the cost of materials (US$26,133) and personnel (US$138,452). The internal referral strategy was the largest source of trial contacts (748/1196; 63%), consents (107/150; 71%), and minority consents (17/34; 50%) and was the most expensive strategy (US$139,033). CTA ads generated the second largest number of trial contacts (326/1196; 27%), the most minority contacts (184/321; 57%), and 16 minority consents (16/34; 47%), at a total cost of US$15,562. The other three strategies yielded many fewer contacts and consents. The methods of health events, CTA ads, and the internal strategy showed some evidence of cost-effectiveness (ICER: US$581, US$717, and US$1524, respectively). The CTA strategy was the most cost-effective strategy for minority accrual (ICER: US$908). LIMITATIONS: Recall bias may have limited the accuracy of estimated time spent on recruitment by study personnel. Also, costs spent specifically on minority accrual were unobtainable; results may not be generalizable to other settings; and cost-effectiveness data for the methods of media, health events, and direct mail should be interpreted with caution since these methods generated few consents. CONCLUSIONS: Public transportation ads have the potential to generate numerous minority contacts and consents at a reasonable cost within an urban setting. Combined with traditional methods of recruitment, this method can lead to timelier study completion and increased minority accrual. Future research should prospectively track recruitment and costs in order to better assess the cost-effectiveness of recruitment methods used to target minority populations.
Clinical Trials 01/2013; 10(2). DOI:10.1177/1740774512471452 · 1.93 Impact Factor
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This systematic review was conducted to synthesize the existing evidence regarding key considerations influencing African Americans' participation in cancer clinical trials (CCTs).
The PubMed and PsycINFO databases were searched to identify peer-reviewed publications during the last decade (2002-2011) that met our inclusionary criteria. Our search utilized Boolean combinations of the following terms: "clinical trial"; "cancer"; "neoplasm"; "African American"; "Black"; "caregiver"; "decision making"; "recruitment"; "companion"; "family"; "significant other"; and "social support".
A total of 267 articles were identified in the database searches. Of these articles, a total of 31 were determined to meet the inclusion criteria and were retained for review. Key issues that emerged as impediments to a successful recruitment of African Americans to CCTs included negative attitudes towards clinical trials, low levels of knowledge and awareness regarding CCTs, religious beliefs, and structural barriers, such as transportation, childcare, and access to health care. Recommendations from physicians, family members, and friends may promote CCT participation. Multimedia, and culturally-appropriate recruitment approaches may also be effective in soliciting participation among African Americans.
Existing research underscores the importance of social support from family and friends, cultural appropriateness and sensitivity from physicians and in the design of the CCT, and enhanced education among African Americans in decision-making processes. As African Americans are underrepresented in CCTs, targeted strategies to enhance recruitment efforts and improve cancer treatment outcomes are essential.
Contemporary clinical trials 04/2013; 35(2). DOI:10.1016/j.cct.2013.03.007 · 1.94 Impact Factor
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