Involving American Indians and medically underserved rural populations in cancer clinical trials
TL;DR: Clinical trial participation in this medically underserved population was low overall, but approximately 3-fold higher than reported national accrual rates.
Abstract: PURPOSE: To assess cancer clinical trial recruitment and reasons for nonaccrual among a rural, medically underserved population served by a community-based cancer care center.
METHODS: We prospectively tracked clinical trial enrollment incidence among all new patients presenting at the Rapid City Regional Cancer Care Institute. Evaluating physicians completed questionnaires for each patient regarding clinical trial enrollment status and primary reasons for nonenrollment. Patients who identified as American Indian were referred to a program where patients were assisted in navigating the medical system by trained, culturally competent staff.
RESULTS: Between September 2006 and January 2008, 891 new cancer patients were evaluated. Seventy-eight patients (9%; 95% confidence intervals, 7-11%) were enrolled on a clinical treatment trial. For 73% (95% confidence intervals, 69-75%) of patients (646 of 891) lack of relevant protocol availability or protocol inclusion criteria restrictiveness was the reason for nonenrollment. Only 45 (5%; 95% confidence intervals, 4-7%) patients refused enrollment on a trial. Of the 78 enrolled on a trial, 6 (8%; 95% confidence intervals, 3-16%) were American Indian. Three additional American Indian patients were enrolled under a nontreatment cancer control trial, bringing the total percentage enrolled of the 94 American Indians who presented to the clinic to 10% (95% confidence intervals, 5-17%).
LIMITATIONS: Eligibility rates were unable to be calculated and cross validation of the number in the cohort via registries or ICD-9 codes was not performed.
CONCLUSION: Clinical trial participation in this medically underserved population was low overall, but approximately 3-fold higher than reported national accrual rates. Lack of availability of protocols for common cancer sites as well as stringent protocol inclusion criteria were the primary obstacles to clinical trial enrollment. Targeted interventions using a Patient Navigation program were used to engage AI patients and may have resulted in higher clinical trial enrollment among this racial/ethnic group.
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TL;DR: There is building evidence of some degree of efficacy of patient Navigation in terms of increasing cancer screening rates, but there is less recent evidence concerning the benefit of patient navigation with regard to diagnostic follow‐up and in the treatment setting, and a paucity of research focusing on patient navigation in cancer survivorship remains.
Abstract: Although patient navigation was introduced 2 decades ago, there remains a lack of consensus regarding its definition, the necessary qualifications of patient navigators, and its impact on the continuum of cancer care. This review provides an update to the 2008 review by Wells et al on patient navigation. Since then, there has been a significant increase in the number of published studies dealing with cancer patient navigation. The authors of the current review conducted a search by using the keywords "navigation" or "navigator" and "cancer." Thirty-three articles published from November 2007 through July 2010 met the search criteria. Consistent with the prior review, there is building evidence of some degree of efficacy of patient navigation in terms of increasing cancer screening rates. However, there is less recent evidence concerning the benefit of patient navigation with regard to diagnostic follow-up and in the treatment setting, and a paucity of research focusing on patient navigation in cancer survivorship remains. Methodological limitations were noted in many studies, including small sample sizes and a lack of control groups. As patient navigation programs continue to develop across North America and beyond, further research will be required to determine the efficacy of cancer patient navigation across all aspects of the cancer care continuum.
422 citations
Cites background from "Involving American Indians and medi..."
...In the present review, articles were centered on cancer screening rates,(59-61,73,77,81,82,85,92,101) cancer diagnosis outcomes,(61,64,68,69,84,92,93) cancer treatment outcomes,(58,65,66,74,86,94,98,99) and clinical trial enrollment.(72,96) One qualitative study identified the desire patients expressed for patient navigation services throughout the continuum of care, including into long-term survivorship....
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...Multiple studies noted the importance placed on ensuring that patient navigators were trained in terms of cultural and linguistic capacities appropriate to the population served.(59,72,85) The majority of patient navigators were compensated for their efforts as opposed to being volunteers....
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...A total of 23 citations met the criteria for inclusion in this review.(58-61,63-66,68,69,72-75,77,79,81,82,84,85,87,89,90) An additional 10 articles fitting the inclusion criteria were identified independently of the PubMed search....
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...Several research efforts focused on underserved urban patient populations,(59,69,84) whereas some examined underserved rural populations, particularly Native Americans.(72,75,79) Minority patient populations were included in a large number of studies,(59,60,63,68,69,72,73,75,81) as were low-income populations....
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...A total of 255 citations resulted, of which 42 referenced cancer patient navigation as previously described.(9,13,14,27,48,56-91) A total of 23 citations met the criteria for inclusion in this review....
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TL;DR: These findings emphasize the enormous need to address structural and clinical barriers to trial participation, which combined make trial participation unachievable for more than three of four cancer patients.
Abstract: Background Barriers to cancer clinical trial participation have been the subject of frequent study, but the rate of trial participation has not changed substantially over time. Studies often emphasize patient-related barriers, but other types of barriers may have greater impact on trial participation. Our goal was to examine the magnitude of different domains of trial barriers by synthesizing prior research. Methods We conducted a systematic review and meta-analysis of studies that examined the trial decision-making pathway using a uniform framework to characterize and quantify structural (trial availability), clinical (eligibility), and patient/physician barrier domains. The systematic review utilized the PubMed, Google Scholar, Web of Science, and Ovid Medline search engines. We used random effects to estimate rates of different domains across studies, adjusting for academic vs community care settings. Results We identified 13 studies (nine in academic and four in community settings) with 8883 patients. A trial was unavailable for patients at their institution 55.6% of the time (95% confidence interval [CI] = 43.7% to 67.3%). Further, 21.5% (95% CI = 10.9% to 34.6%) of patients were ineligible for an available trial, 14.8% (95% CI = 9.0% to 21.7%) did not enroll, and 8.1% (95% CI = 6.3% to 10.0%) enrolled. Rates of trial enrollment in academic (15.9% [95% CI = 13.8% to 18.2%]) vs community (7.0% [95% CI = 5.1% to 9.1%]) settings differed, but not rates of trial unavailability, ineligibility, or non-enrollment. Conclusions These findings emphasize the enormous need to address structural and clinical barriers to trial participation, which combined make trial participation unachievable for more than three of four cancer patients.
268 citations
TL;DR: Multiple and flexible strategies targeting providers and participants at provider sites and within communities might be needed to enroll underrepresented populations into clinical trials.
186 citations
Cites background from "Involving American Indians and medi..."
...Hiring research staff from within the community or who reflected community demographics [40,41,43,45,47,49,56,60] [45,46,48]...
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...Material and direct outreach, with an emphasis on culturally sensitive material and in the native language [40,41,43,45,46,48,57,60] [25,45,46,57]...
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...Provided patient navigators, either at community practices or at the academic center/hospital site [44,64] [44,60,64]...
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TL;DR: A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improveAccrual to cancer clinical trials.
Abstract: In 2010, the National Cancer Institute and the American Society of Clinical Oncology cosponsored a symposium to examine the state of clinical trial accrual science and identify opportunities to facilitate trial enrollment. The authors provide recommendations for best practices and for future research developed from the symposium.
116 citations
TL;DR: The results suggest the importance of developing a tailored, barriers-focused navigation intervention to improve participation among diverse racial and ethnic populations.
Abstract: Exciting new medical therapies for a number of diseases that disproportionately affect African Americans and Latinos are currently being developed and tested in clinical trials (Robinson & Trochim, 2007). Despite bearing an unequal burden of disease, African Americans and Latinos continue to be underrepresented in clinical trials research, even though the National Institutes of Health Revitalization Act of 1993 (P.L. 103-43) stipulating the participation of women and minority groups in research was created in 1993 and updated in 2001 (Pinsky et al., 2008). Insufficient representation of racially and ethnically diverse groups and women in clinical trials results in inequitable distribution of the risks and benefits of research participation and reduces the generalizability of trial results (Pinsky et al., 2008). Health disparities in the United States could be reduced if targeted therapies were discovered that work equally well in all populations or work especially well in members of affected racial and ethnic groups.
The purpose of this study was to use qualitative data obtained via focus groups with African American and Latino adults ages 50 years and older to elicit potential solutions to the problem of low rates of participation of such populations in clinical trials research. The conceptual framework of the study was based on the Institute of Medicine (IOM) report Unequal Treatment: Confronting Racial and Ethnic Disparities in Healthcare (Smedley & Nelson, 2003), which identified three factors as major sources of racial and ethnic disparities in health outcomes: (1) characteristics of health care systems, (2) perceptions of and actual interactions with health care providers, and (3) preferences and attitudes of patients.
We applied IOM's conceptual framework to the arena of disparities in recruitment of diverse populations to clinical trials research by revising the wording of the IOM framework to refer to clinical trials research instead of to health care disparities. For example, in the framework, we replaced “health care systems” with “health care systems and study processes,” “health care providers” with “researchers,” and “patients” with “potential trial participants.” The revised framework is depicted in Figure Figure11 and is described in the following sections. The conceptual framework is related to the systems approach in the field of social work, in which clients and their needs are related to a multilevel model of resources, systems, and institutions (Darnell, 2007; NASW, 2008).
Figure 1:
Model Framework of Multilevel Factors Affecting Decision to Participate in a Clinical Trial
114 citations
References
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TL;DR: Although the total number of trial participants increased during the study period, the representation of racial and ethnic minorities decreased and were less likely to enroll in cooperative group cancer trials than were whites, men, and younger patients, respectively.
Abstract: ContextDespite the importance of diversity of cancer trial participants with
regard to race, ethnicity, age, and sex, there is little recent information
about the representation of these groups in clinical trials.ObjectiveTo characterize the representation of racial and ethnic minorities,
the elderly, and women in cancer trials sponsored by the National Cancer Institute.Design, Setting, and PatientsCross-sectional population-based analysis of all participants in therapeutic
nonsurgical National Cancer Institute Clinical Trial Cooperative Group breast,
colorectal, lung, and prostate cancer clinical trials in 2000 through 2002.
In a separate analysis, the ethnic distribution of patients enrolled in 2000
through 2002 was compared with those enrolled in 1996 through 1998, using
logistic regression models to estimate the relative risk ratio of enrollment
for racial and ethnic minorities to that of white patients during these time
periods.Main Outcome MeasureEnrollment fraction, defined as the number of trial enrollees divided
by the estimated US cancer cases in each race and age subgroup.ResultsCancer research participation varied significantly across racial/ethnic
and age groups. Compared with a 1.8% enrollment fraction among white patients,
lower enrollment fractions were noted in Hispanic (1.3%; odds ratio [OR] vs
whites, 0.72; 95% confidence interval [CI], 0.68-0.77; P<.001) and black (1.3%; OR, 0.71; 95% CI, 0.68-0.74; P<.001) patients. There was a strong relationship between age and
enrollment fraction, with trial participants 30 to 64 years of age representing
3.0% of incident cancer patients in that age group, in comparison to 1.3%
of 65- to 74-year-old patients and 0.5% of patients 75 years of age and older.
This inverse relationship between age and trial enrollment fraction was consistent
across racial and ethnic groups. Although the total number of trial participants
increased during our study period, the representation of racial and ethnic
minorities decreased. In comparison to whites, after adjusting for age, cancer
type, and sex, patients enrolled in 2000 through 2002 were 24% less likely
to be black (adjusted relative risk ratio, 0.76; 95% CI, 0.65-0.89; P<.001). Men were more likely than women to enroll in
colorectal cancer trials (enrollment fractions: 2.1% vs 1.6%, respectively;
OR, 1.30; 95% CI, 1.24-1.35; P<.001) and lung
cancer trials (enrollment fractions: 0.9% vs 0.7%, respectively; OR, 1.23;
95% CI, 1.16-1.31; P<.001).ConclusionsEnrollment in cancer trials is low for all patient groups. Racial and
ethnic minorities, women, and the elderly were less likely to enroll in cooperative
group cancer trials than were whites, men, and younger patients, respectively.
The proportion of trial participants who are black has declined in recent
years.
1,823 citations
"Involving American Indians and medi..." refers background in this paper
...Furthermore, American Indian patients are among the most underrepresented reports on clinical trial enrollment by race/ethnicity, [2,4,7,17] and are enrolled at rates disproportionately lower than their percentage of the U....
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TL;DR: Increasing the supply of pragmatic or practical clinical trials will depend on the development of a mechanism to establish priorities for these studies, significant expansion of an infrastructure to conduct clinical research within the health care delivery system, more reliance on high-quality evidence by health care decision makers, and a substantial increase in public and private funding forThese studies.
Abstract: Decision makers in health care are increasingly interested in using highquality scientific evidence to support clinical and health policy choices; however, the quality of available scientific evidence is often found to be inadequate. Reliable evidence is essential to improve health care quality and to support efficient use of limited resources. The widespread gaps in evidencebased knowledge suggest that systematic flaws exist in the production of scientific evidence, in part because there is no consistent effort to conduct clinical trials designed to meet the needs of decision makers. Clinical trials for which the hypothesis and study design are developed specifically to answer the questions faced by decision makers are called pragmatic or practical clinical trials (PCTs). The characteristic features of PCTs are that they (1) select clinically relevant alternative interventions to compare, (2) include a diverse population of study participants, (3) recruit participants from heterogeneous practice settings, and (4) collect data on a broad range of health outcomes. The supply of PCTs is limited primarily because the major funders of clinical research, the National Institutes of Health and the medical products industry, do not focus on supporting such trials. Increasing the supply of PCTs will depend on the development of a mechanism to establish priorities for these studies, significant expansion of an infrastructure to conduct clinical research within the health care delivery system, more reliance on high-quality evidence by health care decision makers, and a substantial increase in public and private funding for these studies. For these changes to occur, clinical and health policy decision makers will need to become more involved in all aspects of clinical research, including priority setting, infrastructure development, and funding.
1,675 citations
"Involving American Indians and medi..." refers background in this paper
...However, we recognize that a call for expansion in the number of clinical trials offered may meet constraints in the current research funding climate, [36] or may possibly detract from scientific purity and rigor needed to establish causal relationships in evaluation of interventions [37]....
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TL;DR: Differences in cancer incidence, mortality, and survival in relation to race/ethnicity, and census data on poverty in the county or census tract of residence are highlighted.
Abstract: This article highlights disparities in cancer incidence, mortality, and survival in relation to race/ethnicity, and census data on poverty in the county or census tract of residence. The incidence and survival data derive from the National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results (SEER) Program; mortality data are from the National Center for Health Statistics (NCHS); data on the prevalence of major cancer risk factors and cancer screening are from the National Health Interview Survey (NHIS) conducted by NCHS. For all cancer sites combined, residents of poorer counties (those with greater than or equal to 20% of the population below the poverty line) have 13% higher death rates from cancer in men and 3% higher rates in women compared with more affluent counties (less than 10% below the poverty line). Differences in cancer survival account for part of this disparity. Among both men and women, five-year survival for all cancers combined is 10 percentage points lower among persons who live in poorer than in more affluent census tracts. Even when census tract poverty rate is accounted for, however, African American, American Indian/Alaskan Native, and Asian/Pacific Islander men and African American and American Indian/Alaskan Native women have lower five-year survival than non-Hispanic Whites. More detailed analyses of selected cancers show large variations in cancer survival by race and ethnicity. Opportunities to reduce cancer disparities exist in prevention (reductions in tobacco use, physical inactivity, and obesity), early detection (mammography, colorectal screening, Pap tests), treatment, and palliative care.
1,629 citations
"Involving American Indians and medi..." refers background in this paper
...This is especially relevant to our population, when considering that many protocols were not available for advanced-stage disease in combination with fact that American Indians present disproportionately at more advanced stages of cancer [10,12,24]....
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TL;DR: Race remained strongly associated with a higher distrust score and even after controlling for markers of social class, African Americans were less trusting than white Americans.
Abstract: Background: Investigators have voiced concerns that distrust of research and the medical community inpedes successful recruitment of African Americans into clinical research. Objective: To examine possible differences in distrust by race and to determine to what extent other sociodemographic factors explain any racial differences in distrust. Methods: We analyzed data from 527 African American and 382 white respondents of a national telephone survey on participation in clinical research. Our main outcome was a 7-item index of distrust. Results: African American respondents were more likely that white respondents not to trust that their physicians would fully explain research participation (41.7% vs 23.4%,P<.01)and to state that they believed their physicians exposed them to unnecessary risks (45.5% vs 34.8%,P<.01). African American respondents had a significantly higher mean distrust index score than white respondents(3.1 vs 1.8,P<.01). After controlling for other sociodemographic variables in a logistic regression model, race remained strongly associated with a highter distrust score (prevalence odds ratio, 4.7;95% confidence interval,2.9-7.7). Conclusions: Even after controlling for markers of social class, African Americans were less trusting than white Americans. Racial differences in disturst have important implications for investigation as they engage African Americans in research.
935 citations
TL;DR: New data resources and improved study methodology are needed to better identify and quantify the full spectrum of nonclinical factors that contribute to the higher cancer mortality among racial/ethnic minorities and to develop strategies to facilitate receipt of appropriate cancer care for all patients.
Abstract: A disproportionate number of cancer deaths occur among racial/ethnic minorities, particularly African Americans, who have a 33% higher risk of dying of cancer than whites. Although differences in incidence and stage of disease at diagnosis may contribute to racial disparities in mortality, evidence of racial disparities in the receipt of treatment of other chronic diseases raises questions about the possible role of inequities in the receipt of cancer treatment. To evaluate racial/ethnic disparities in the receipt of cancer treatment, we examined the published literature that addressed access/use of specific cancer treatment procedures, trends in patterns of use, or survival studies. We found evidence of racial disparities in receipt of definitive primary therapy, conservative therapy, and adjuvant therapy. These treatment differences could not be completely explained by racial/ethnic variation in clinically relevant factors. In many studies, these treatment differences were associated with an adverse impact on the health outcomes of racial/ethnic minorities, including more frequent recurrence, shorter disease-free survival, and higher mortality. Reducing the influence of nonclinical factors on the receipt of cancer treatment may, therefore, provide an important means of reducing racial/ethnic disparities in health. New data resources and improved study methodology are needed to better identify and quantify the full spectrum of nonclinical factors that contribute to the higher cancer mortality among racial/ethnic minorities and to develop strategies to facilitate receipt of appropriate cancer care for all patients.
916 citations