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Motivators and barriers to Latinas' participation in clinical trials: the role of contextual factors.

ABSTRACT: OBJECTIVE:Latinas are underrepresented in clinical trials despite the rise in Hispanic population. This study examines the factors associated with Latinas' willingness to participate in preventive breast cancer randomized clinical trials (RCTs). METHODS:Women self-identifying as Latina, over age 40, with no prior history of breast cancer were eligible. Using the Behavior Model for Vulnerable Populations, we administered a survey (n=168) to assess predisposing (e.g., knowledge), enabling (e.g., trust) and need factors (e.g., risk perception). Intention to participate was defined using a lenient (maybe, probably or definitely) and a stringent criterion (probably and definitely). Chi-square tests and logistic regression models examined the associations of predisposing, enabling, and need factors with women's intentions to participate in RCTs. RESULTS:Most participants (74.9%) were monolingual Spanish-speaking immigrants. Most (83.9%) reported willing to participate in clinical trials using the lenient definition (vs. 43.1% under the stringent definition). Using the lenient definition, the odds of willing to participate in RCTs were significantly lower for unmarried women (OR=.25, 95% CI=.08-.79) and those with lower cancer risk perceptions (OR=.20, 95% CI=.06-.63), while being significantly higher for women with lower language acculturation (OR=6.2, 95% CI=1.8-20.9). Using the stringent definition, women who did not endorse a motivation to enroll to help family members (if they had cancer) had significantly lower odds to report intent (OR=.33, 95% CI=.13-.86). CONCLUSION:Many RCTs may have limited generalizability due to the low representation of minorities. Culturally targeted interventions that address the importance of family for Latinos may ultimately increase their participation in RCTs.

SUBMITTER: London L

PROVIDER: S-EPMC4357359 | biostudies-other | 2015 Jan

REPOSITORIES: biostudies-other

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Motivators and barriers to Latinas' participation in clinical trials: the role of contextual factors.

London Laricca L Hurtado-de-Mendoza Alejandra A Song Minna M Nagirimadugu Ankita A Luta Gheorghe G Luta Gheorghe G Sheppard Vanessa B VB

Contemporary clinical trials 20141126

<h4>Objective</h4>Latinas are underrepresented in clinical trials despite the rise in Hispanic population. This study examines the factors associated with Latinas' willingness to participate in preventive breast cancer randomized clinical trials (RCTs).<h4>Methods</h4>Women self-identifying as Latina, over age 40, with no prior history of breast cancer were eligible. Using the Behavior Model for Vulnerable Populations, we administered a survey (n=168) to assess predisposing (e.g., knowledge), en ...[more]

PMID: 25433203

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Project description:ImportanceA systematic assessment of existing research should justify the conduct and inform the design of new clinical research but is often lacking. There is little research on the barriers to and factors facilitating systematic evidence assessments.ObjectiveTo examine the practices and attitudes of Swiss stakeholders and international funders regarding conducting systematic evidence assessments in academic clinical trials.Design, setting, and participantsIn this qualitative study, individual semistructured qualitative interviews were conducted between February and August 2020 with 48 Swiss stakeholder groups (27 primary investigators, 9 funders and sponsors, 6 clinical trial support organizations, and 6 ethics committee members) and between January and March 2021 with 9 international funders of clinical trials from North America and Europe with a reputation for requiring systematic evidence synthesis in applications for academic clinical trials.Main outcomes and measuresThe main outcomes were practices and attitudes of Swiss stakeholders and international funders regarding conducting systematic evidence assessments in academic clinical trials. Interviews were analyzed using conventional content analysis.ResultsOf the 57 participants, 40 (70.2%) were male. Participants universally acknowledged that a comprehensive understanding of the previous evidence is important but reported wide variation regarding how this should be achieved. Participants reported that the conduct of formal systematic reviews was currently not expected before most clinical trials, but most international funders reported expecting a systematic search for the existing evidence. Whereas time and resources were reported by all participants as barriers to conducting systematic reviews, the Swiss research ecosystem was reported not to be as supportive of a systematic approach compared with international settings.Conclusions and relevanceIn this qualitative study, Swiss stakeholders and international funders generally agreed that new clinical trials should be justified by a systematic evidence assessment but that barriers on individual, organizational, and political levels kept them from implementing it. More explicit requirements from funders appear to be needed to clarify the required level of comprehensiveness in summarizing existing evidence for different types of clinical trials.

Project description:BackgroundThe National Clinical Trials Network program conducts phase 2 or phase 3 treatment trials across all National Cancer Institute's designated cancer centers. Participant accrual across these clinical trials is a critical factor in deciding their success. Cancer centers that cater to rural populations, such as The University of Kansas Cancer Center, have an additional responsibility to ensure rural residents have access and are well represented across these studies.ObjectiveThere are scant data available regarding the factors that act as barriers to the accrual of rural residents in these clinical trials. This study aims to use electronic screening logs that were used to gather patient data at several participating sites in The Kansas University of Cancer Center's Catchment area.MethodsScreening log data were used to assess what clinical trial participation barriers are faced by these patients. Additionally, the differences in clinical trial participation barriers were compared between rural and urban participating sites.ResultsAnalysis revealed that the hospital location rural urban category, defined as whether the hospital was in an urban or rural setting, had a medium effect on enrolment of patients in breast cancer and lung cancer trials (Cohen d=0.7). Additionally, the hospital location category had a medium effect on the proportion of recurrent lung cancer cases at the time of screening (d=0.6).ConclusionsIn consideration of the financially hostile nature of cancer treatment as well as geographical and transportation barriers, clinical trials extended to rural communities are uniquely positioned to alleviate the burden of nonmedical costs in trial participation. However, these options can be far less feasible for patients in rural settings. Since the number of patients with cancer who are eligible for a clinical trial is already limited by the stringent eligibility criteria required of such a complex disease, improving accessibility for rural patients should be a greater focus in health policy.

Project description:To ensure generalizability of clinical research results, it is important to enroll a heterogeneous population that is representative of the target clinical population. Earlier studies have found regional variation in participation in human immunodeficiency virus (HIV) clinical trials, with the lowest rates seen in the southern United States. Rates of new HIV diagnoses are highest in the South, highlighting the need for in-depth understanding of disparities in clinical trial participation. We evaluated whether regional variation in study participation remains, and describe factors that facilitate or prevent HIV clinical trial participation by region.A one-time, anonymous, bilingual, self-administered survey was conducted among HIV-infected adults receiving HIV care at all 47 domestic AIDS Clinical Trials Group clinical research sites, with a goal of completing 50 surveys per site. ?(2) tests were used to evaluate differences in knowledge of and participation in HIV clinical trials by region, including Northeast, Midwest, South, and West regions. Multivariable logistic regression was used to estimate odds ratios and 95% confidence intervals (CIs) for the effect of region on knowledge of and participation in HIV clinical trials.Of 2263 completed surveys, 2125 were included in this analysis. The proportion of respondents in the South who reported knowledge of studies (66%) was significantly lower than in the Northeast (76%), Midwest (77%), and West (73%) (P = 0.001). Respondents in the South also were the least likely group to report ever having tried to or having participated in a research study (51%) compared with respondents in the Northeast (60%), Midwest (57%), and West (69%; P < 0.001). After adjusting for age, sex, education, race/ethnicity, tobacco use, and alcohol use, the odds ratio for knowledge of and participation in clinical trials for the Northeast (1.36; 95% CI 1.07-1.72) and West (1.85; 95% CI 1.39-2.45) remained significant compared with the South. African American respondents in the South were the most likely population group to report not understanding research studies (15%) as a reason for not participating, compared with the Northeast (9%), Midwest (8%), and West (6%; P < 0.001).Significant regional variations in knowledge of and participation in HIV clinical trials exist. Our results suggest that increasing awareness and understanding of research studies, particularly among African Americans in the South, may facilitate HIV clinical trial participation that is more representative of the HIV-infected population across the United States.

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Motivators and barriers to Latinas' participation in clinical trials: the role of contextual factors.

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Motivators and barriers to Latinas' participation in clinical trials: the role of contextual factors.

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