Patient Lung Cancer Screening Decisions and Environmental and Psychosocial Factors.

Importance: Screening for lung cancer using low-dose computed tomography is associated with reduced lung cancer-specific mortality, but uptake is low in the US; understanding how patients make decisions to engage with lung cancer screening is critical for increasing uptake. Prior research has focused on individual-level psychosocial factors, but environmental factors (eg, historical contexts that include experiencing racism) and modifying factors-those that can be changed to make it easier or harder to undergo screening-also likely affect screening decisions. Objective: To investigate environmental, psychosocial, and modifying factors influencing lung cancer screening decision-making and develop a conceptual framework depicting relationships between these factors. Design, Setting, and Participants: This multimethod qualitative study was conducted from December 2021 to June 2022 using virtual semistructured interviews and 4 focus groups (3-4 participants per group). All participants met US Preventive Services Task Force eligibility criteria for lung cancer screening (ie, age 50-80 years, at least a 20 pack-year smoking history, and either currently smoke or quit within the past 15 years). Screening-eligible US participants were recruited using an online panel. Main Outcomes and Measures: Key factors influencing screening decisions (eg, knowledge, beliefs, barriers, and facilitators) were the main outcome. A theory-informed, iterative inductive-deductive approach was applied to analyze data and develop a conceptual framework summarizing results. Results: Among 34 total participants (interviews, 20 [59%]; focus groups, 14 [41%]), mean (SD) age was 59.1 (4.8) years and 20 (59%) identified as female. Half had a household income below $20 000 (17 [50%]). Participants emphasized historical and present-day racism as critical factors contributing to mistrust of health care practitioners and avoidance of medical procedures like screening. Participants reported that other factors, such as public transportation availability, also influenced decisions. Additionally, participants described psychosocial processes involved in decisions, such as perceived screening benefits, lung cancer risk appraisal, and fear of a cancer diagnosis or harmful encounters with practitioners. In addition, participants identified modifying factors (eg, insurance coverage) that could make receiving screening easier or harder. Conclusions and Relevance: In this qualitative study of patient lung cancer screening decisions, environmental, psychosocial, and modifying factors influenced screening decisions. The findings suggest that systems-level interventions, such as those that help practitioners understand and discuss patients' prior negative health care experiences, are needed to promote effective screening decision-making.

Relative predictive value of sociodemographic factors for chronic diseases among All of Us participants: a descriptive analysis.

BACKGROUND: Although sociodemographic characteristics are associated with health disparities, the relative predictive value of different social and demographic factors remains largely unknown. This study aimed to describe the sociodemographic characteristics of All of Us participants and evaluate the predictive value of each factor for chronic diseases associated with high morbidity and mortality. METHODS: We performed a cross-sectional analysis using de-identified survey data from the All of Us Research Program, which has collected social, demographic, and health information from adults living in the United States since May 2018. Sociodemographic data included self-reported age, sex, gender, sexual orientation, race/ethnicity, income, education, health insurance, primary care provider (PCP) status, and health literacy scores. We analyzed the self-reported prevalence of hypertension, coronary artery disease, any cancer, skin cancer, lung disease, diabetes, obesity, and chronic kidney disease. Finally, we assessed the relative importance of each sociodemographic factor for predicting each chronic disease using the adequacy index for each predictor from logistic regression. RESULTS: Among the 372,050 participants in this analysis, the median age was 53 years, 59.8% reported female sex, and the most common racial/ethnic categories were White (54.0%), Black (19.9%), and Hispanic/Latino (16.7%). Participants who identified as Asian, Middle Eastern/North African, and White were the most likely to report annual incomes greater than $200,000, advanced degrees, and employer or union insurance, while participants who identified as Black, Hispanic, and Native Hawaiian/Pacific Islander were the most likely to report annual incomes less than $10,000, less than a high school education, and Medicaid insurance. We found that age was most predictive of hypertension, coronary artery disease, any cancer, skin cancer, diabetes, obesity, and chronic kidney disease. Insurance type was most predictive of lung disease. Notably, no two health conditions had the same order of importance for sociodemographic factors. CONCLUSIONS: Age was the best predictor for the assessed chronic diseases, but the relative predictive value of income, education, health insurance, PCP status, race/ethnicity, and sexual orientation was highly variable across health conditions. Identifying the sociodemographic groups with the largest disparities in a specific disease can guide future interventions to promote health equity.

Communication Interactions, Needs, and Preferences During Clinical Encounters of African American Parent-Child Dyads.

Human papillomavirus (HPV) vaccination rates remain suboptimal among African American adolescents. Although provider recommendations during clinical encounters are believed to be highly effective in increasing uptake and series completion, little has been reported about parent-child perspectives on the counseling received during these encounters. Among African American parent-child dyads, we sought to explore and compare interactions, needs, and preferences during clinical encounters by child's HPV vaccination status. We applied a qualitative, phenomenological study design to conduct semi-structured interviews with African American parent-child dyads representing children who were unvaccinated (n = 10), had initiated but not completed (n = 11), or had completed the HPV vaccine series (n = 9). Using iterative, inductive-deductive thematic analysis, five themes were generated: (1) parents' attitudes varied about the HPV vaccine but were mostly positive for vaccines in general; (2) patient-parent-provider clinical encounters from the parent perspective; (3) patient-parent-provider clinical encounters from the child perspective; (4) methods of distribution of supplemental HPV information; and (5) communication desired on HPV vaccination by parents and children. Parents stating they received a provider's recommendation increased by vaccination status (unvaccinated: 6 out of 10; initiated: 7 out of 11; completed: 9 out of 9). Most parents and children were not satisfied with provider communication on the HPV vaccine and used supplemental materials to inform decision-making. Ongoing communication on the HPV vaccine was requested even post-vaccination of the child. During clinical encounters, children and parental messaging needs are similar yet dissimilar. We offer communication strategies and messaging that can be used for African American parent-child dyads by child HPV vaccination status during a clinical encounter.

Correction: Development of a Tailored Mobile Phone-Based Intervention to Facilitate Parent-Child Communication and Build Human Papillomavirus Vaccine Confidence: Formative Qualitative Study.

[This corrects the article DOI: 10.2196/43041.].

Development of a Tailored Mobile Phone-Based Intervention to Facilitate Parent-Child Communication and Build Human Papillomavirus Vaccine Confidence: Formative Qualitative Study.

BACKGROUND: Human papillomavirus (HPV) vaccine hesitancy is on the rise, and provider communication is a first-line strategy to address parental concerns. The use of the presumptive approach and motivational interviewing by providers may not be enough to influence parental decision-making owing to the providers' limited time, self-efficacy, and skills to implement these strategies. Interventions to enhance provider communication and build parental HPV vaccine confidence have been undertested. Delivering tailored patient education to parents via mobile phones before they visit the health care provider may address time constraints during clinic visits and positively affect vaccine uptake. OBJECTIVE: This study aimed to describe the development and evaluate the acceptability of a mobile phone-based, family-focused intervention guided by theory to address concerns of HPV vaccine-hesitant parents before the clinic visit, as well as explore intervention use to facilitate parent-child communication. METHODS: The health belief model and theory of reasoned action guided intervention content development. A multilevel stakeholder engagement process was used to iteratively develop the HPVVaxFacts intervention, including a community advisory board review, a review by an advisory panel comprising HPV vaccine-hesitant parents, a health communications expert review, semistructured qualitative interviews with HPV vaccine-hesitant parents (n=31) and providers (n=15), and a content expert review. Inductive thematic analysis was used to identify themes in the interview data. RESULTS: The qualitative interviews yielded 4 themes: overall views toward mobile device use for health information, acceptability of HPVVaxFacts, facilitators of HPVVaxFacts use, and barriers to HPVVaxFacts use. In parent interviews after reviewing HPVVaxFacts prototypes, almost all parents (29/31, 94%) stated they intended to have their child vaccinated. Most of the parents stated that they liked the added adolescents' corner to engage in optional parent-child communication (ie, choice to share and discuss information with their child; 27/31, 87%) and shared decision-making in some cases (8/31, 26%). After incorporating all input, the final intervention consisted of a 10-item survey to identify the top 3 concerns of parents, followed by tailored education that was mapped to each of the following concerns: evidential messages, images or graphics to enhance comprehension and address low literacy, links to credible websites, a provider video, suggested questions to ask their child's physician, and an optional adolescents' corner to educate the patient and support parent-child communication. CONCLUSIONS: The multilevel stakeholder-engaged process used to iteratively develop this novel intervention for HPV vaccine-hesitant families can be used as a model to develop future mobile health interventions. This intervention is currently being pilot-tested in preparation for a randomized controlled trial aiming to increase HPV vaccination among adolescent children of vaccine-hesitant parents in a clinic setting. Future research can adapt HPVVaxFacts for other vaccines and use in other settings (eg, health departments and pharmacies).

Assessing patient-level knowledge of precision medicine in a community health center setting.

As precision medicine approaches are implemented, cancer treatment decisions have come to require comprehension of genetic tests and their role in risk stratification and treatment options. Acceptance and implementation of precision medicine requires patient understanding of numeracy, genetic literacy, health literacy, and medical trust. Implementing precision medicine in a US federally qualified community health center (FQCHC) setting has received little attention. Using a mixed-methods approach, we sought to identify patient-level factors influencing the understanding of cancer risk and precision medicine among FQCHC patients. We enrolled 26 English-speaking adults aged 40-79 years. Participants enrolled in focus groups and completed surveys to assess patient-level understanding of precision medicine, numeracy, and health literacy. The majority of participants were female (77%) and self-identified as African American (89%). Approximately one-third reported having a high school degree or less. While health literacy was generally high, 42% felt that genes or genetics had little impact on health and most (69%) reported little familiarity with precision medicine. Many participants reported that trust in their providers was extremely or very important when receiving genetic tests. Numeracy levels were moderate, with nearly half reporting some discomfort working with fractions and 38% finding numerical information only occasionally useful. Findings suggest that patients may lack familiarity with precision medicine concepts relevant for understanding cancer treatment decisions. Future educational efforts may help bridge the gap in patient understanding and facilitate equitable opportunities for precision medicine for all patients, including those seeking care from community health centers.

Healthcare providers' practice protocols, strategies, and needed tools to address parental HPV vaccine hesitancy: An exploratory study.

Parental hesitancy related to human papillomavirus (HPV) vaccines has increased during the pandemic, and there is a call to action by the National HPV Vaccination Roundtable to improve vaccination rates. While there are evidence-based strategies available to address parental hesitancy, there are few clear guidelines on how to engage parents to build confidence in the HPV vaccine within the clinical settings. The purpose of this investigation is to explore practice protocols, individual provider strategies, and perceived tools needed to address HPV vaccine hesitant parents from the perspective of providers during the COVID-19 pandemic in the United States. Fifteen healthcare providers participated in qualitative, semi-structured interviews between May 2021 and March 2022. An inductive, qualitative content analysis approach was used to analyze the data. Five themes were described: 1) Provider experiences engaging with HPV vaccine hesitant parents; 2) Existing protocols in the clinics to address HPV vaccine hesitant parents; 3) Strategies used by providers to address parental HPV vaccine hesitancy; 4) Sample message content used by providers to address parental HPV vaccine concerns; and 5) Perceived strategies and tools needed to address parental vaccine hesitancy. Recommendations to address parental hesitancy include recommending HPV vaccinationat 9 years, using a strong recommendation and continued discussion, applying evidence-based approaches and/or promising strategies, linking parents to credible outside sources, and ongoing follow-up if delayed or declined. These findings can be used by researchers and clinicians to improve strategies and messages to inform the development of a protocol to standardize encounters and communication for patient-parent-provider encounters that can influence parental decision-making around HPV vaccine uptake.

The All of Us Research Program: Data quality, utility, and diversity.

The All of Us Research Program seeks to engage at least one million diverse participants to advance precision medicine and improve human health. We describe here the cloud-based Researcher Workbench that uses a data passport model to democratize access to analytical tools and participant information including survey, physical measurement, and electronic health record (EHR) data. We also present validation study findings for several common complex diseases to demonstrate use of this novel platform in 315,000 participants, 78% of whom are from groups historically underrepresented in biomedical research, including 49% self-reporting non-White races. Replication findings include medication usage pattern differences by race in depression and type 2 diabetes, validation of known cancer associations with smoking, and calculation of cardiovascular risk scores by reported race effects. The cloud-based Researcher Workbench represents an important advance in enabling secure access for a broad range of researchers to this large resource and analytical tools.

Determinants of stage at diagnosis of HPV-related cancer including area deprivation and clinical factors.

BACKGROUND: Collecting social determinants of health in electronic health records is time-consuming. Meanwhile, an Area Deprivation Index (ADI) aggregates sociodemographic information from census data. The objective of this study was to ascertain whether ADI is associated with stage of human papillomavirus (HPV)-related cancer at diagnosis. METHODS: We tested for the association between the stage of HPV-related cancer presentation and ADI as well as the association between stage and the value of each census-based measure using ordered logistic regression, adjusting for age, race and sex. RESULTS: Among 3247 cases of HPV-related cancers presenting to an urban academic medical center, the average age at diagnosis was 57. The average stage at diagnosis was Surveillance, Epidemiology and End Results Stage 3. In the study population, 43% of patients were female and 87% were white. In this study population, there was no association between stage of HPV-related cancer presentation and either aggregate or individual census variables. CONCLUSIONS: These results may reflect insufficient sample size, a lack of socio-demographic diversity in our population, or suggest that simplifying social determinants of health into a single geocoded index is not a reliable surrogate for assessing a patient's risk for HPV-related cancer.

Health Care Professionals' Perspectives on Universal Screening of Social Determinants of Health: A Mixed-Methods Study.

Social determinants of health (SDH) contribute to nearly 50% of health outcomes; however, SDH data collection is inconsistent in clinical practice. This study used mixed methods to evaluate health care professionals' perceptions of universal SDH screening at an academic medical center by surveying physicians, advanced practice providers, nurses, social workers, case managers, pharmacists, and administrators. An electronic survey assessed SDH screening practices, prioritization of SDH domains, disciplines to perform screening, and attitudes and barriers to universal screening. Likert-scale responses were dichotomized and compared disciplines with proportions tests. Qualitative interviews identified themes and elaborated survey findings. Participant discipline was the primary predictor variable. Of 193 survey participants (62.5% response rate), most were physicians (31%) or social workers (22%). Participants overwhelmingly reported using SDH information in patient care (93%), and social workers as the most appropriate role for screening (95%). Most respondents (75%) believed health literacy is important, but 40% reported routine assessment. Housing status (73% vs. 53%) and financial strain (62% vs. 48%) followed similar patterns. SDH screening barriers included lacking resources to address identified needs (51%), time to ask (45%), support staff to ask (33%), and training in responding to identified needs (28%). Social workers cited barriers less often than non-social workers (P < 0.001). Qualitative interviews (n = 16) supported survey findings and described barriers including lack of time, resources, standardized approaches, and professional burnout. Health care professionals support universal SDH screening while highlighting the need to address implementation barriers. Strategies should leverage social work expertise and optimize SDH data accessibility for all providers.

Engaging smokers in research: Utility of Facebook in facilitating recruitment to a smoking cessation study.

INTRODUCTION: Social media, including Facebook outreach, is increasingly being used as a participant recruitment tool, and may be particularly useful in tobacco and smoking cessation studies. The Recruitment Innovation Center at Vanderbilt University Medical Center partnered with Project LUNA, a smoking cessation study, to conduct a pilot social media campaign aimed at increasing study recruitment. METHODS: Two posts encouraging study participation were developed and promoted on Facebook to users with an interest in smoking-related topics, with a link to a study-specific webpage. Facebook and website analytics were collected, including impressions, clicks, click-through rates, website traffic, and clicks to the study screening form. Study screening and enrollment data were also collected. RESULTS: The Facebook campaign ran in June 2019 in the greater Houston area. In total, the Facebook posts logged 1,179,844 impressions, 6490 clicks, and an overall click-through rate of 0.55%. There were no differences in response to the two different promotional posts. Approximately 3812 unique individuals visited an intermediary study page, with 473 expressing interest in the study. Forty-three potential participants contacted the study team, resulting in study enrollment and randomization of 23 participants, with an estimated cost per enrolled participant of $441. CONCLUSIONS: The social media campaign was successful at increasing outreach and interest in the LUNA study. However, the price-per-participant enrolled was higher than in comparable tobacco cessation studies. These results and lessons learned may be beneficial to others considering social media as a recruitment method for their clinical research trial.

A pilot study of a culturally-appropriate, educational intervention to increase participation in cancer clinical trials among African Americans and Latinos.

AIM: Culturally-appropriate, educational programs are recommended to improve cancer clinical trial participation among African Americans and Latinos. This study investigated the effect of a culturally-appropriate, educational program on knowledge, trust in medical researchers, and intent for clinical trial participation among African Americans and Latinos in Middle Tennessee. METHOD: Trained community health educators delivered a 30-min presentation with video testimonials to 198 participants in 13 town halls. A pre-post survey design was used to evaluate the intervention among 102 participants who completed both pre- and post-surveys one to two weeks after the session. RESULTS: Paired-sample t-test showed significant increases in unadjusted mean scores for knowledge (p < 0.001), trust in medical researchers (p < 0.001), and willingness to participate in clinical trials (p = 0.003) after the town halls in the overall sample. After adjusting for gender and education, all three outcomes remained significant for the overall sample (knowledge: p < 0.001; trust in medical researchers: p < 0.001; willingness: p = 0.001) and for African Americans (knowledge: p < 0.001; trust in medical researchers: p = 0.007; willingness: p = 0.005). However, willingness to participate was no longer significant for Latinos (knowledge: p < 0.001; trust in medical researchers: p = 0.034; willingness: p = 0.084). CONCLUSIONS: The culturally-appropriate, educational program showed promising results for short-term, clinical trial outcomes. Further studies should examine efficacy to improve research participation outcomes.

The Astounding Breadth of Health Disparity: Phenome-Wide Effects of Race on Disease Risk.

OBJECTIVE: We conducted a phenotype-wide association study (PheWAS) to compare diagnoses among Blacks with those of Whites in one health center in Tennessee using data from 1,883,369 patients. METHODS: We used our deidentified EHR, the Synthetic Derivative, to assess risk of diagnoses associated with Black as compared with White race using Firth logistic regression with covariates including age, sex, and density of clinical encounters. RESULTS: There were anchoring associations in both directions, including the highest increased risk for Blacks of having sickle cell anemia, and strongest decreased risk of basal cell carcinoma. Results included established areas of disparity and many novel associations. CONCLUSIONS: PheWAS is a viable tool for calculating risk associated with any biomarker. The current analysis provide a new approach to generating hypotheses and understanding the breadth of health disparities. Future analyses will further explore causality, risk factors, and potential confounders not accounted for here.

Formative research to design a culturally-appropriate cancer clinical trial education program to increase participation of African American and Latino communities.

BACKGROUND: Addressing knowledge deficiencies about cancer clinical trials and biospecimen donation can potentially improve participation among racial and ethnic minorities. This paper describes the formative research process used to design a culturally-appropriate cancer clinical trials education program for African American and Latino communities. We characterized community member feedback and its integration into the program. METHODS: We incorporated three engagement approaches into the formative research process to iteratively develop the program: including community-based organization (CBO) leaders as research team members, conducting focus groups and cognitive interviews with community members as reviewers/consultants, and interacting with two community advisory groups. An iterative-deductive approach was used to analyze focus group data. Qualitative data from advisory groups and community members were compiled and used to finalize the program. RESULTS: Focus group themes were: 1) Community Perspectives on Overall Presentation; 2) Community Opinions and Questions on the Content of the Presentation; 3) Culturally Specific Issues to Participation in Cancer Clinical Trials; 4) Barriers to Clinical Trial Participation; and 5) Perspectives of Community Health Educators. Feedback was documented during reviews by scientific experts and community members with suggestions to ensure cultural appropriateness using peripheral, evidential, linguistic, sociocultural strategies, and constituent-involving. The final program consisted of two versions (English and Spanish) of a culturally-appropriate slide presentation with speaker notes and videos representing community member and researcher testimonials. CONCLUSIONS: Incorporating multiple community engagement approaches into formative research processes can facilitate the inclusion of multiple community perspectives and enhance the cultural-appropriateness of the programs designed to promote cancer clinical trial participation among African Americans and Latinos.

Providers' Perceptions of Parental Human Papillomavirus Vaccine Hesitancy: Cross-Sectional Study.

BACKGROUND: Human papillomavirus (HPV) vaccine hesitancy among parents contributes to low vaccination coverage in adolescents. To improve health care provider communication and vaccine recommendation practices with hesitant parents, it is important to understand how providers perceive parental HPV vaccine hesitancy. OBJECTIVE: This study aimed to characterize perceived reasons for parental HPV vaccine hesitancy and identify factors associated with perceived parental hesitancy among providers at community-based pediatric clinics. METHODS: In 2018, providers in 23 community-based pediatric clinics in Tennessee were invited to complete a Web-based baseline survey as part of a larger quality improvement study focused on HPV vaccine uptake. These survey data were used for a cross-sectional, secondary data analysis. Scale scores ranging from 0 to 100 were calculated for provider self-efficacy (confidence in ability to recommend HPV vaccine), provider outcome expectations (expectations that recommendation will influence parents' decisions), and perceived parental HPV vaccine hesitancy. Provider confidence in HPV vaccine safety and effectiveness were categorized as high versus low. Clinic-level exposures examined were clinic size and rural-urban location. Descriptive analyses were used to characterize perceived parental barriers by provider type. Mixed-effects linear regression models were fit taking one exposure variable at a time, whereas controlling for provider type, age, gender, and race to identify provider- and clinic-level factors associated with perceived parental barriers to HPV vaccination. RESULTS: Of the 187 providers located in the 23 clinics, 137 completed the survey. The majority of physician providers were white and female, with a higher percentage of females among nurse practitioners (NPs) and physician assistants (PAs). The most common parental barriers to HPV vaccination perceived by providers were concerns about HPV vaccine safety (88%), child being too young (78%), low risk of HPV infection for child through sexual activity (70%), and mistrust in vaccines (59%). In adjusted mixed models, perceived parental HPV vaccine hesitancy was significantly associated with several provider-level factors: self-efficacy (P=.001), outcome expectations (P<.001), and confidence in HPV vaccine safety (P=.009). No significant associations were observed between perceived parental HPV vaccine hesitancy and clinic-level factors clinic size nor location. CONCLUSIONS: Researchers developing provider-focused interventions to reduce parental HPV vaccine hesitancy should consider addressing providers' self-efficacy, outcome expectations, and confidence in HPV vaccine safety to help providers communicate more effectively with HPV vaccine hesitant parents.

Group Versus Individual Educational Sessions With a Promotora and Hispanic/Latina Women's Satisfaction With Care in the Screening Mammography Setting: A Randomized Controlled Trial.

OBJECTIVE. We studied Hispanic/Latina women's satisfaction with care after receiving group or individual educational sessions (vs standard of care) with a promotora before screening mammography. A promotora is a culturally appropriate community health worker for the Hispanic/Latino community. Promotoras have been shown to increase screening mammography rates and follow-up of abnormal mammograms in this population. However, a promotora's impact on elements of patient care and patient satisfaction remains poorly described. MATERIALS AND METHODS. Hispanic/Latina women 40-64 years old were randomized to one of three groups: the control group (standard-of-care well woman screening), an individual educational session with a promotora followed by well woman screening with access to the promotora, or a group educational session followed by well woman screening with access to the promotora. Access to the promotora included the opportunity to ask questions during well woman screening and a follow-up telephone call to discuss results and follow-up if necessary. Participants completed a premammography survey that assessed demographics and health literacy and a postmammography survey that assessed satisfaction with care, interpersonal processes of care, and satisfaction with the promotora. We used multivariable linear regression models and two-sample t tests for continuous outcome measures and a multivariable logistic regression model for dichotomized outcomes. RESULTS. Of the 100 women enrolled in the study, 94 completed well woman screening and the postmammography survey. Hispanic/Latina women with access to the promotora providing educational sessions in either the group (mean satisfaction with care score, 78.1) or individual (mean satisfaction with care score, 78.8) setting reported higher satisfaction with care than those receiving the standard of care (mean satisfaction with care score, 74.9) (p < 0.05). The odds of highly compassionate care in women receiving educational sessions was increased and was particularly strong for those receiving individual educational sessions compared with standard of care (odds ratio, 4.78 [95% CI, 1.51-15.13]). We found that increased satisfaction with the promotora was significantly associated with increased satisfaction with care but that group versus individual educational sessions did not significantly impact satisfaction with the promotora. CONCLUSION. Our study findings have important implications as patient navigators and shared decision making become integral to cancer screening. Group educational sessions may offer a method to decrease the time and expense of providing educational services in the cancer screening setting. However, the overall more positive interpersonal experiences suggested in the individual setting suggest that a larger study is warranted to better understand differences between group and individual educational settings.

The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge in Ethnic Minorities: A Randomized Control Trial.

Introduction: Innovative methods to increase awareness about clinical trials and address barriers associated with low participation among racial/ethnic minorities are desperately needed. African Americans comprise 5% of all clinical trial participants, and Hispanics make up 1%. Use of multimedia educational material has shown promise as an effective strategy to increase minority clinical trial enrollment. However, this approach has not been broadly implemented. We tested the effect of a video educational program on clinical trial knowledge and enrollment in a sample of oncology outpatients. Methods: A randomized controlled trial was conducted with 63 oncology patients without previous history of clinical trial participation. Participants were randomly assigned to the intervention, to watch a clinical trial educational video in the office, or to the control group which did not receive in-office education. The Clinical Trial Knowledge survey was administered before the intervention and 1 week after the intervention. Participation in clinical trials was assessed 1-year post study participation. Results for white participants and ethnic minorities were compared. Ethnicity was self-reported through the electronic health record and confirmed by self-reporting on questionnaire. Results: Sixty-three participants were recruited in this study. At 1-year follow-up, 3 participants enrolled in clinical trials in the study group which had received office-based video intervention and 2 participants enrolled in the control group (Z = 0.39, p = 0.69). These results were not statistically significant. Impact of the intervention by ethnicity could not be assessed due to low total clinical trial enrollment. The video intervention did not change knowledge, attitudes, or barriers as measured by the Clinical Trial Knowledge Survey. Minority participants did report significantly more negative beliefs and barriers to participation than white participants. Conclusions: Increasing awareness and knowledge about clinical trials in underrepresented communities is an important step to providing opportunities for participation. Future studies should focus on how to address the negative expectations of clinical trials and the greater information needs in minority populations. Tailored or personalized messaging may address negative perceptions of clinical trial participation.

Women's response to state-mandated language in dense breast notification.

Many states require radiologists to notify women of dense breast status. Our aim was to elicit women's response to state-mandated dense breast notification language. Of respondents, 82% report that current notification does not inform them of additional screening studies available, and 41% report notification does not inform them of next steps. Open-ended responses indicate three main areas of patient concern: Decisional Needs, Decision Quality, and Decision Support. We modified an existing Decision Support framework to capture additional themes specific to dense breast decisions. The developed framework can be used to revise and improve current breast density reporting methods.