Outcomes from the Body & Soul Clinical Trials Project: A university-church partnership to improve African American enrollment in a clinical trial registry
TL;DR: A culturally tailored education program about CTs can increase enrollment of African Americans in a university-based clinical trials registry and improve minority CT enrollment over time.
Abstract: Objectives
Historically, African Americans have been underrepresented in clinical trials (CTs) compared to whites. A growing number of research institutions have created CT registries to match volunteers with appropriate studies. In a sample of 745 African Americans from 16 churches, we tested the impact of a culturally tailored intervention aimed at increasing enrollment in a university-based CT registry.
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TL;DR: In this article, the authors provide an update since a systematic review in 2012, on the current status of the empirical research, with a particular focus on the elements of CBPR methods used to improve the rate of accrual of members of racial and ethnic minority communities for clinical trials.
Abstract: There has not been a significant improvement in the rate of clinical trial accrual in more than 20 years. Worse, the challenge of inadequate representation among racial and ethnic minorities also persists, deepening disparities in health. Community-Based Participatory Research (CBPR) is a participatory communication method that centers on effective dialogue between researchers and community stakeholders with the goal of creating an equitable partnership for health and social change. The objective of the current study was to provide an update since a systematic review in 2012, on the current status of the empirical research, with a particular focus on the elements of CBPR methods used to improve the rate of accrual of members of racial and ethnic minority communities for clinical trials. Our systematic review found a large increase in the number of CBPR related studies and studies related to racial and ethnic representation in research. More than 85% of studies employing CBPR methods saw statistically positive outcomes. Specifically, the elements of CBPR that are associated with these positive outcomes include community partner participation in (1) a study advisory committee, (2) data collection, (3) the development of interventions, and (4) participant recruitment. However, the results of our study indicate that researchers need to be more transparent about the extent of community participation as well as more thoroughly and accurately describe the nature of the partnership with members of minority communities in order to build upon the scientific literature on community-engaged methods.
31 citations
TL;DR: Results indicate that African-American and Hispanic-American participants have more negative attitudes about clinical trials, more distrust toward doctors, more interest in complementary and alternative medicine, and less willingness to participate in clinical trials than white/non-Hispanics, although specific factors affecting willingness to participation vary.
Abstract: African-Americans and Hispanic-Americans are disproportionately affected by cancer, yet underrepresented in cancer clinical trials. Because of this, it is important to understand how attitudes and beliefs about clinical trials vary by ethnicity. A national, random sample of 860 adults was given an online survey about attitudes toward clinical trials. We examined willingness to participate in clinical trials, attitudes toward clinical trials, trust in doctors, attitudes toward alternative and complementary medicine, and preferred information channels. Results indicate that African-American and Hispanic-American participants have more negative attitudes about clinical trials, more distrust toward doctors, more interest in complementary and alternative medicine, and less willingness to participate in clinical trials than white/non-Hispanics, although specific factors affecting willingness to participate vary. The channels people turn to for information on clinical trials also varied by ethnicity. These results help explain the ethnic disparities in cancer clinical trial enrollment by highlighting some potential underlying causes and drawing attention to areas of importance to these groups.
30 citations
TL;DR: This study examined factors associated with an invitation to participate in biomedical research, intent to participateIn biomedical research in the future, and participation in biomedicalResearch and biospecimen donation among a diverse, multilingual, community‐based sample across 3 distinct geographic areas.
Abstract: Background Engaging diverse populations in biomedical research, including biospecimen donation, remains a national challenge. This study examined factors associated with an invitation to participate in biomedical research, intent to participate in biomedical research in the future, and participation in biomedical research and biospecimen donation among a diverse, multilingual, community-based sample across 3 distinct geographic areas. Methods Three National Cancer Institute-designated cancer centers engaged in community partnerships to develop and implement population health assessments, reaching a convenience sample of 4343 participants spanning their respective catchment areas. Data harmonization, multiple imputation, and multivariable logistic modeling were used. Results African Americans, Hispanic/Latinos, and other racial minority groups were more likely to be offered opportunities to participate in biomedical research compared to whites. Access to care, history of cancer, educational level, survey language, nativity, and rural residence also influenced opportunity, intent, and actual participation in biomedical research. Conclusions Traditionally underserved racial and ethnic groups reported heightened opportunity and interest in participating in biomedical research. Well-established community partnerships and long-standing community engagement around biomedical research led to a diverse sample being reached at each site and may in part explain the current study findings. However, this study illustrates an ongoing need to establish trust and diversify biomedical research participation through innovative and tailored approaches. National Cancer Institute-designated cancer centers have the potential to increase opportunities for diverse participation in biomedical research through community partnerships and engagement. Additional work remains to identify and address system-level and individual-level barriers to participation in both clinical trials and biospecimen donation for research.
27 citations
Cites background from "Outcomes from the Body & Soul Clini..."
...The diversity of the research participants in the current study, and the increased likelihood of participation in biomedical research among underrepresented racial and ethnic groups, may be due in part to each site’s collaborations with local, well-established, and long-standing community partners and our ongoing outreach, engagement, and research programs.(13,34-36) The results of the current study also highlight opportunities for NCI-designated cancer centers to build on and leverage community and institutional relationships to better understand and enhance health communication and behavior around biomedical research participation....
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01 Sep 2021
TL;DR: The strengths and weakness of culturally tailored interventions for ethnic minorities’ care in the United States are identified and recently published studies are reviewed to improve understanding of these interventions for future research and practice.
Abstract: Aim This scoping review identifies strengths and weakness of culturally tailored interventions for ethnic minorities' care in the United States. It reviews recently published studies to improve understanding of these interventions for future research and practice. Design Scoping review. Methods By searching five electronic databases-CINAHL, PubMed, Ovid, Scopus and Web of Science, this review located 58 empirical studies published between 2015-2019. This review was guided by the PRISMA statements. Results The review identified four weaknesses and five strengths of culturally tailored interventions. Weaknesses included unclear guidelines, low attention and retention rates, failure to measure processes and inadequate training for healthcare providers. The intervention strengths were culturally respectful and patient-centred care, healthy lifestyle promotion, increased family and community supports, technology use for efficient and timely care and increased knowledge of disease by participants.
26 citations
Cites background from "Outcomes from the Body & Soul Clini..."
...…301) • “Additionally, there was not an equal dose of CT (clinical trial) educational messages for the comparison churches, which limits internal validity” (Langford et al., 2015, p. 254) (Continues) Main theme Subtheme Relevant study quotation Inadequate training for healthcare providers •…...
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...Retaining participants for the entirety of an intervention is imperative to ensure research is valid and reliable and to gain adequate power of sample (Langford et al., 2015)....
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...Langford et al. (2015) reported that they could not conduct the study with equal dose of usual care to the control group and observed that this threatened the study's internal validity....
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...While we had few challenges recruiting participants into the study, at one year follow up, we were able to obtain follow up questionnaires on 575 participants out of 745 (77%)” (Langford et al., 2015, p. 254) • “Our average attendance was 7.4/12 or 61.6%, with a majority (55.5...
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TL;DR: Data from two cycles of the National Cancer Institute's Health Information National Trends Survey collected in 2015 and 2017 were merged and analyzed and found that those higher in information seeking confidence were more likely to report high trust across all models.
Abstract: Public trust in traditional sources of health information is essential for public health agencies and organizations to perform necessary public health functions. Little research has examined levels and predictors of trust in government health agencies and national health organizations. Additionally, few studies have simultaneously analyzed trust in multiple health topics. The major aim of this study was to compare levels and factors associated with trust in national health sources across three health topics: information about tobacco, electronic cigarettes, and general health. Data from two cycles of the National Cancer Institute's Health Information National Trends Survey collected in 2015 and 2017 were merged and analyzed for this study (n = 5,474). A series of weighted multivariable logistic regression models calculated odds of high trust in government health agencies and health organizations for each health topic. More respondents reported high trust in health organizations than for government health agencies across all topics. More participants reported high trust in these sources tobacco information, as compared to general health or e-cigarette information. Logistic models found that those higher in information seeking confidence were more likely to report high trust across all models. Other demographic variables were inconsistent predictors of trust across topics. This study highlights inconsistent sociodemographic predictors of trust across multiple health topics and national health sources. Researchers, practitioners, and policymakers should consider the unique context of specific health topics in health promotion campaigns, partner with existing community-based organizations, and encourage and enable health information seeking.
22 citations
References
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TL;DR: The results indicated that underrepresented populations face numerous barriers to participation in cancer‐related trials, and 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.
Abstract: 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.
865 citations
TL;DR: Multivariate analysis found that the perception of racism and mistrust of the medical care system led to less satisfaction with care and when perceived racism and medical mistrust were controlled, race was no longer a significant predictor of satisfaction.
Abstract: The authors examine determinants of satisfaction with medical care among 1,784 (781 African American and 1,003 white) cardiac patients. Patient satisfaction was modeled as a function of predisposing factors (gender, age, medical mistrust, and perception of racism) and enabling factors (medical insurance). African Americans reported less satisfaction with care. Although both black and white patients tended not to endorse the existence of racism in the medical care system, African American patients were more likely to perceive racism. African American patients were significantly more likely to report mistrust. Multivariate analysis found that the perception of racism and mistrust of the medical care system led to less satisfaction with care. When perceived racism and medical mistrust were controlled, race was no longer a significant predictor of satisfaction.
856 citations
TL;DR: These findings, based on the research enrollment decisions of over 70,000 individuals, the vast majority from the US, suggest that racial and ethnic minorities in the US are as willing as non-Hispanic whites to participate in health research.
Abstract: Background: It is widely claimed that racial and ethnic minorities, especially in the US,are less willing than non-minority individuals to participate in health research. Yet,there is a paucity of empirical data to substantiate this claim. Methods and Findings: We performed a comprehensive literature search to identify all puublished health research studies that report consent rates by race or ethnicity. We found 20 health research studies that reported consent rates by race or ethnicity. These 20 studies reported the enrollment decisions of over 70,000 individuals for a broad range of research,from interviews to drug treatment to surgical trials. Eighteen of the twenty studies were single-site studies conducted exclusively in the US or multi-site studies where the majority of sites (i.e., at least 2/3) were in the US. Of the remaining two studies, the Concorde study was conducted at 74 sites in the United Kingdom, Ireland, and France, while the Delta study was conducted at 152 sites in Europe and 23 sites in Australia and New Zealand. For the three interview or non-intervention studies, African-Americans had a nonsignificantly lower overall consent rate than non-Hispanic whites (82.2% versus 83.5%; odds ratio [OR] ¼ 0.92; 95% confidence interval [CI] 0.84–1.02). For these same three studies, Hispanics had a nonsignificantly higher overall consent rate than non-Hispanic whites (86.1% versus 83.5%; OR ¼ 1.37; 95% CI 0.94–1.98). For the ten clinical intervention studies, African-Americans’ overall consent rate was nonsignificantly higher than that of non-Hispanic whites (45.3% versus 41.8%; OR¼1.06; 95% CI 0.78–1.45). For these same ten studies, Hispanics had a statistically significant higher overall consent rate than non-Hispanic whites (55.9% versus 41.8%; OR¼1.33; 95% CI 1.08–1.65). For the seven surgery trials, which report all minority groups together, minorities as a group had a nonsignificantly higher overall consent rate than non-Hispanic whites (65.8% versus 47.8%; OR ¼ 1.26; 95% CI 0.89–1.77). Given the preponderance of US sites, the vast majority of these individuals from minority groups were African-Americans or Hispanics from the US. Conclusions We found very small differences in the willingness of minorities, most of whom were African-Americans and Hispanics in the US, to participate in health research compared to non-Hispanic whites. These findings, based on the research enrollment decisions of over 70,000 individuals, the vast majority from the US, suggest that racial and ethnic minorities in the US are as willing as non-Hispanic whites to participate in health research. Hence, efforts to increase minority participation in health research should focus on ensuring access to health research for all groups, rather than changing minority attitudes.
743 citations
TL;DR: A narrative review of the available literature, based mainly on US studies, aims to make sense of the issues around under-representation by providing a theoretical reconciliation and offers a number of strategies for improving ethnic minority accrual rates in clinical trials.
Abstract: Randomised controlled trials (RCTs) are considered to be the gold standard in evaluating medical interventions; however, people from ethnic minorities are frequently under-represented in such studies. The present paper addresses a previously neglected debate about the tensions which inform clinical trial participation amongst people from ethnic minorities, in particular, South Asians, the largest ethnic minority group in the UK. In a narrative review of the available literature, based mainly on US studies, the present authors aim to make sense of the issues around under-representation by providing a theoretical reconciliation. In addition, they identify a number of potential barriers to ethnic minority participation in clinical trials. In so doing, the authors recognise that the recent history of eugenic racism, and more general views on clinical trials as a form of experimentation, means that clinical trial participation among people from ethnic minorities becomes more problematic. Lack of participation and the importance of representational sampling are also considered, and the authors argue that health professionals need to be better informed about the issues. The paper concludes by offering a number of strategies for improving ethnic minority accrual rates in clinical trials, together with priorities for future research.
356 citations