Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review

Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer-related trials. The authors conducted a systematic review to determine the barriers to participation of underrepresented populations in cancer-related trials. Their search included English-language publications that reported original data on the recruitment of underrepresented groups to cancer treatment or prevention trials between 1966 and December 2005 in multiple electronic databases. They also hand-searched titles in 34 journals from January 2003 to December 2005 and they examined reference lists for eligible articles. Titles and abstracts were reviewed to identify relevant studies. Data on barriers to participation were synthesized both qualitatively and based on statistically significant associations with trial enrollment. Of 5257 studies that were cited, 65 studies were eligible for inclusion in the current analysis, including 46 studies on recruitment into cancer therapeutic trials, 15 studies on recruitment into prevention trials, and 4 studies on recruitment into both prevention and treatment trials. Numerous factors were reported as barriers to participation in cancer-related trials. However, only 20 of the studies reported statistically significant associations between hypothesized barriers and enrollment. The available evidence had limitations in quality regarding representativeness, justification of study methods, the reliability and validity of data-collection methods, potential for bias, and data analysis. The results indicated that underrepresented populations face numerous barriers to participation in cancer-related trials. The current systematic review highlighting the literature on recruitment of underrepresented populations to cancer trials and may be used as the evidence base toward developing an agenda for etiologic and intervention research to reduce the disparities in participation in cancer-related trials.     

The impact of socioeconomic status on access to cancer clinical trials

Cancer clinical trials enable the development of novel agents for the potential benefit of cancer patients. Enrolment in a trial offers patients the chance of superior efficacy coupled to the risk of unanticipated toxicity. For trial results to be generalisable, the data need to be collected in patients'' representative of the general cancer population. Socioeconomic deprivation is associated with poor cancer outcomes. In the developed world, the gap between the most and least deprived is widening. This mini-review explores the evidence regarding socioeconomics and access to cancer trials, highlighting the underrepresentation of deprived patients, and exploring reasons for this disparity.     

Undercutting efforts of precision medicine: roadblocks to minority representation in breast cancer clinical trials

Breast Cancer Research and Treatment - Precision (or personalized) medicine holds great promise in the treatment of breast cancer. The success of personalized medicine is contingent upon...     

Increasing accrual in cancer clinical trials with a focus on minority enrollment: The William Beaumont Hospital Community Clinical Oncology Program Experience

BACKGROUND:

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).

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.     

Lay patient navigator program implementation for equal access to cancer care and clinical trials: essential steps and initial challenges

BACKGROUND: Disparities in cancer detection, treatment, and outcomes among racial/ethnic minorities and low-income patients are well documented. One way to reduce these disparities is to use patient navigators to address barriers to care. However, little information about optimal characteristics of navigator programs or considerations for those interested in setting up such programs is available. METHODS: The design and implementation of a patient navigator program for underserved cancer patients in an urban, nonacademic community hospital setting is described. The program, which used lay navigators, was conceived as a component of the Urban Latino African American Cancer (ULAAC) Disparities Project in South Los Angeles, a National Cancer Institute (NCI)-sponsored project to improve cancer care and clinical trial access for minority and low-income patients. RESULTS: Careful initial planning, including input from a community advisory committee, was essential to smooth program implementation. Thirty-one volunteers completed navigator training in the program's first year of operation. Of 135 patients offered navigation services, 75 (56%) accepted, and preliminary feedback from patients, navigators, and providers suggests high levels of satisfaction with navigation. Standardized templates used by navigators and staff to record key information are proving helpful for monitoring quality and outcomes (such as effectiveness in addressing specific barriers to care) and continually improving the program. CONCLUSIONS: The ULAAC program represents a viable model for developing lay navigator programs in community hospitals. Preliminary assessments suggest that the program has a positive effect on minority and low-income cancer patients' experience with care and reduces barriers to care. Additional time and research are needed, however, to fully assess the impact on care and outcomes.     

Recruiting minority cancer patients into cancer clinical trials: a pilot project involving the Eastern Cooperative Oncology Group and the National Medical Association.

PURPOSE: Minority accrual onto clinical trials is of significant interest to cooperative oncology study groups. The Eastern Cooperative Oncology Group (ECOG) conducted a study to identify barriers and solutions to African American accrual onto clinical trials. METHODS: We hypothesize that the National Medical Association (NMA) might provide insight into ways to increase minority participation and that ECOG might facilitate that participation. Four sites were selected in which NMA chapters existed and ECOG main institutions with less than half of the corresponding percentage of minorities in their communities entered trials for 1992. Fifteen workshops were conducted using discussions and open-ended, self-administered questionnaires. RESULTS: Seventy percent of NMA physicians cited mistrust of the research centers, fear of losing patients, and a lack of respect from ECOG institutions as the most important barriers to minority cancer patient referrals, compared with 30% for ECOG physicians. Sixty-nine percent of NMA and 43% of ECOG physicians cited a lack of information about specific trials. Nearly half of NMA physicians (47%) cited a lack of minority investigators as a barrier, compared with 4% of ECOG physicians. Solutions by both groups were improved communication (73%) and culturally relevant educational materials (40%). ECOG physicians cited more minority outreach staff as a potential solution (22% v 6%). NMA physicians cited increased involvement of referring physicians (44% v4%). CONCLUSION: NMA physicians who serve a significant sector of the African American population demonstrated a willingness to participate and work with a cooperative group effort to increase participation of minority patients and investigators.     

Establishing trusting partnerships for successful recruitment of American Indians to clinical trials.

BACKGROUND: Cancer mortality rates among American Indians (AIs) in the Northern Plains are among the highest in the nation. Reasons for this disparity are unclear but are probably due to multiple barriers. AIs appear to experience more intense side effects from therapeutic radiation compared with other populations. This differential response to treatment, a disparity in itself, might be overcome if the molecular reasons were better understood. METHODS: The National Cancer Institute developed the Cancer Disparity Research Partnership to address these inequities. This initiative, known as the Walking Forward program, attempts to lower cancer mortality rates for AIs by increasing access to innovative clinical trials, behavioral research, patient navigation, and the ataxia telangiectasia mutated (ATM) gene study. The ATM component of the project was initiated to determine if there is a molecular basis for this apparent differential response to therapeutic radiation. Successful implementation of the genetic study relied on achieving a trusting partnership with AIs since a lack of trust has historically been a barrier to performing research in this population. The authors detail the nature of building partnerships and trust by utilizing lessons learned. RESULTS: Establishing a trusting partnership between a community hospital and AIs in South Dakota resulted in successful recruitment to this ATM clinical trial. To date, 26 AIs and 40 non-AIs have consented to participate in this ATM analysis. Their shared human desire to assist others, especially family and community members, and their demonstrated responsiveness to community priorities by academic researchers are the primary reasons for participant eagerness to enroll on this study. CONCLUSIONS: The relatively rapid approval of the ATM genetic study by multiple tribal organizations and the successful accrual of AIs on this study reflect the trusting partnerships achieved at the patient and community levels.     

Factors that affect breast cancer treatment: underserved and minority populations

Breast cancer treatment in underserved populations continues to deviate from established guidelines. Significant barriers persist at the system, physician, and patient levels that ultimately may affect survival adversely. Successful strategies to reduce the disparities must be developed to improve outcomes in this population of women.     

American Indian/Alaska Native cancer policy: systemic approaches to reducing cancer disparities

Members of American Indian and Alaska Native (AI/AN) tribes have a unique political status in the United States in terms of citizenship, and that political status determines eligibility for certain unique healthcare services. The AI/AN population has a legal right to healthcare services based on treaties, court decisions, acts of Congress, Executive Orders, and other legal bases. Although the AI/AN population has a right to healthcare services, the Indian Health Service (the federal agency responsible for providing healthcare to AI/ANs) is severely underfunded, limiting access to services (including cancer care). In order to overcome distinct cancer health disparities, policy changes will be needed. This paper reviews the historical pattern of AI/AN healthcare and the challenges of the complex care needed from prevention through end-of-life care for cancer.     

Progress from clinical trials and emerging non-conventional therapies for the treatment of Medulloblastomas

Medulloblastomas are highly aggressive tumors of the cerebellum with an embryonal origin. Despite current treatment modalities which include a combination of surgery, chemotherapy and/or radiation, challenges still exist to effectively treat some patients, especially those within the younger age group. In an effort to find improved therapies, ongoing research led by world-wide teams have explored non-conventional therapeutic strategies, as well as examined the efficacy of several drugs in clinical trials among patients with Medulloblastomas. We outline in this article, recent advances on the efficacy and toxicity of numerous therapeutic agents including those that are DNA damaging agents, microtubules binding compounds, and those that are inhibitors of Topoisomerase and of the Notch and Hedgehog signaling pathway, which were assessed in recent Phase I and II clinical trials. Among these clinical trials, it is unfortunate that the outcomes were dismal with the majority of the patients with Medulloblastomas still succumbing to relapse after conventional therapies. Furthermore, it is yet to be established clearly the clinical efficacy of non-conventional therapies such as immunotherapy and gene therapy. Moreover, there is growing interest in proton therapy as a potential replacement for photon therapy, while high dose chemotherapy and autologous stem cell rescue may improve therapeutic efficacies. However, further research is needed to resolve the inherent toxicity from these novel therapeutic methods. In conclusion, novel therapies based on a better understanding of the biology of Medulloblastomas are pivotal in improving non-conventional therapies in the treatment of this deadly disease.