Evidence-based Prostate Cancer Screening Interventions for Black Men: A Systematic Review.

Prostate cancer is the second leading cause of death for men in the U.S. and Black men are twice as likely to die from the disease. However, prostate cancer, if diagnosed at an earlier stage, is curable. The purpose of this review is to identify prostate cancer screening clinical trials that evaluate screening decision-making processes of Black men. METHODS: The databases PubMed, Ovid MEDLINE, CINAHL Plus, and PsychInfo were utilized to examine peer-reviewed publications between 2017 and 2023. Data extracted included implementation plans, outcome measures, intervention details, and results of the study. The Critical Appraisal Skills Programme was used to assess the quality of the evidence presented. RESULTS: Of the 206 full-text articles assessed, three were included in this review. Educational interventions about prostate cancer knowledge with shared and informed decision-making (IDM) features, as well as counseling, treatment options, and healthcare navigation information, may increase prostate cancer screening participation among Black men. Additionally, health partner educational interventions may not improve IDM related to screening participation. The quality of the evidence presented in each article was valid and potentially impactful to the community. DISCUSSION: Black men face various social determinants of health barriers related to racism, discrimination, cost of health services, time away from work, and lack of trust in the healthcare system when making health-related decisions, including prostate cancer screening participation. A multifactorial intervention approach is required to address these inequities faced by Black men especially as prostate cancer is curable when diagnosed at an earlier stage.

More than Just a Number: Perspectives from Black Male Participants on Community-Based Interventions and Clinical Trials to Address Cardiovascular Health Disparities.

BACKGROUND: Black Americans remain significantly underrepresented and understudied in research. Community-based interventions have been increasingly recognized as an effective model for reckoning with clinical trial participation challenges amongst underrepresented groups, yet a paucity of studies implement this approach. The present study sought to gain insight into Black male participants' perception of clinical trials before and after participating in a community-based team lifestyle intervention in the United States. METHODS: Black Impact, a 24-week community-based lifestyle intervention, applied the American Heart Association's Life's Simple 7 (LS7) framework to assess changes in the cardiovascular health of seventy-four Black male participants partaking in weekly team-based physical activities and LS7-themed education and having their social needs addressed. A subset of twenty participants completed an exit survey via one of three semi-structured focus groups aimed at understanding the feasibility of interventions, including their perceptions of participating in clinical trials. Data were transcribed verbatim and analyzed using a content analysis, which involved systematically identifying, coding, categorizing, and interpreting the primary patterns of the data. RESULTS: The participants reported a positive change in their perceptions of clinical trials based on their experience with a community-based lifestyle intervention. Three prominent themes regarding their perceptions of clinical trials prior to the intervention were as follows: (1) History of medical abuse; (2) Lack of diversity amongst research teams and participants; and (3) A positive experience with racially concordant research teams. Three themes noted to influence changes in their perception of clinical trials based on their participation in Black Impact were as follows: (1) Building trust with the research team; (2) Increasing awareness about clinical trials; and (3) Motivating participation through community engagement efforts. CONCLUSIONS: Improved perceptions of participating in clinical trials were achieved after participation in a community-based intervention. This intervention may provide a framework by which to facilitate clinical trial participation among Black men, which must be made a priority so that Black men are "more than just a number" and no longer "receiving the short end of the stick".

A novel approach to assessing disparity in representativeness of clinical trial participants within a large midwestern healthcare system.

Background: Representativeness in clinical trials (CT) serves as a metric of access to healthcare and reflects differences that may determine differential efficacy of medical interventions; thus, quantifying representativeness in CT participation is critical. Methods: This retrospective, descriptive study utilized patient demographic data extracted from the largest Midwestern non-profit healthcare system. Using data between January 1, 2019 and December 31, 2021, a CT Participant Sample of 4,537 system patients who were active CT participants was compared to a CT Patient Population of 195,726 system patients receiving care by the PI of active CTs, which represented the target population. Chi-square goodness-of-fit tests were used to test differences in distributions of demographic variables between groups, indicating disparity in CT participation. Two metrics adapted from literature - participation incidence disparity (PID) and participation incidence ratio (PIR) - were calculated to quantify absolute and relative disparity in representativeness proportions, respectively. Descriptive approaches to assessing representativeness are also provided. Results: Results showed significant differences by race/ethnicity (χ2 = 50.64; p < 0.0001), age categories (χ2 = 56.64; p < 0.0001), and insurance (χ2 = 41.29; p < 0.0001). PID and PIR metrics revealed reduced CT participation among non-White racial/ethnic groups and increased CT participation among White Non-Hispanic patients. Further, CT participants ≥80 or Worker's Compensation were underrepresented while those with Self-Pay insurance were overrepresented as CT participants. Conclusions: Despite progress, continued efforts to not only enroll participants into CTs that are representative of the healthcare system and region, but also to better assess representativeness quantitatively are still needed.

Promoting informed approaches in precision oncology and clinical trial participation for Black patients with cancer: Community-engaged development and pilot testing of a digital intervention.

BACKGROUND: Black patients with cancer are less likely to receive precision cancer treatments than White patients and are underrepresented in clinical trials. To address these disparities, the study aimed to develop and pilot-test a digital intervention to improve Black patients' knowledge about precision oncology and clinical trials, empower patients to increase relevant discussion, and promote informed decision-making. METHODS: A community-engaged approach, including a Community Advisory Board and two rounds of key informant interviews with Black patients with cancer, their relatives, and providers (n = 48) was used to develop and refine the multimedia digital intervention. Thematic analysis was conducted for qualitative data. The intervention was then pilot-tested with 30 Black patients with cancer to assess feasibility, acceptability, appropriateness, knowledge, decision self-efficacy, and patient empowerment; Wilcoxon matched pairs signed-rank test was used to analyze quantitative data. RESULTS: The digital tool was found to be feasible, acceptable, and culturally appropriate. Key informants shared their preferences and recommendations for the digital intervention and helped improve cultural appropriateness through user and usability testing. In the pilot test, appreciable improvement was found in participants' knowledge about precision oncology (z = -2.04, p = .052), knowledge about clinical trials (z = -3.14, p = .001), and decisional self-efficacy for targeted/immune therapy (z = -1.96, p = .0495). CONCLUSIONS: The digital intervention could be a promising interactive decision-support tool for increasing Black patients' participation in clinical trials and receipt of precision treatments, including immunotherapy. Its use in clinical practice may reduce disparities in oncology care and research. PLAIN LANGUAGE SUMMARY: We developed a digital interactive decision support tool for Black patients with cancer by convening a Community Advisory Board and conducting interviews with Black patients with cancer, their relatives, and providers. We then pilot-tested the intervention with newly diagnosed Black patients with cancer and found appreciable improvement in participants' knowledge about precision oncology, knowledge about clinical trials, and confidence in making decisions for targeted/immune therapy. Our digital tool has great potential to be an affordable and scalable solution for empowering and educating Black patients with cancer to help them make informed decisions about precision oncology and clinical trials and ultimately reducing racial disparities.

Do Tobacco Treatment Trials Address Disparities in Smoking Outcomes Among Black and Hispanic Cancer Patients? A Systematic Review of Smoking Cessation Interventions for Black and Hispanic Patients Diagnosed with Cancer.

OBJECTIVE: To characterize the representation of Black and Hispanic cancer patients in tobacco treatment trials, and to offer recommendations for future research. METHODS: We conducted two systematic searches of the literature (2018, 2021) using 5 databases (MEDLINE via EBSCO, Pubmed, PsycInfo, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica Database (EMBASE)) to examine the prevalence of tobacco trials that included Black or Hispanic cancer patients. Two coders independently screened all articles at title, abstract, and full-text to identify eligible trials. Information about the proportion of Black and Hispanic patients included, trial design features, and whether the authors analyzed outcomes for Black and Hispanic patients were documented. RESULTS: Of 4682 identified studies, only 10 published trials included and reported on the rates of Black or Hispanic cancer patients enrolled in their tobacco trial. The proportion of enrolled Black cancer patients ranged from 2 to 55.6%. Only our studies documented enrollment rates for Hispanics, and rates were less than 6%. None of the studies offered strategies to promote or the accrual of Black or Hispanic patients. DISCUSSION: There remains a large gap in the literature regarding the reach and efficacy of tobacco treatment for Black and Hispanic cancer patients. Black and Hispanic cancer patients remain largely under-represented in tobacco cessation trials, limiting the applicability of existing, evidence-based treatments. To optimize intervention generalizability, future studies should emphasize the targeted recruitment and engagement of these patients in tobacco trials.

Clinical trial participation among underserved communities: Insights from the Louisiana Community Engagement Alliance.

BACKGROUND: Diverse, equitable and inclusive participation in clinical research is needed to ensure evidence-based clinical practice and lessen disparities in health outcomes. Yet, clinical trial participation remains critically low in minoritized communities, particularly among Blacks. The Louisiana Community Engagement Alliance against COVID-19 Disparities (LA-CEAL) was launched in response to the disproportionate impact of COVID-19 on Black Louisianans to understand community barriers and preferences and increase inclusive participation in research. This study aims to understand perceptions regarding COVID-19 trial participation among underrepresented Louisianans. METHODS: A rapid assessment integrating cross-sectional, surveys among federally qualified health center (FQHC) patients and community residents, and focus group discussions (FGDs) from community representatives was conducted in 2020-2021. Factors and perceptions underlying trial participation were identified using logistic regression models and thematic analyses, respectively. RESULTS: Quantitative findings (FQHC: N=908, mean age=46.6 years, 66.4% Black; community: N=504, mean age=54.2 years, 93.7% Black) indicated that 0.9% and 3.6%, respectively, ever participated in a COVID-19 trial. Doctors/Healthcare providers were most trusted (FQHC=55.1%; community=59.3%) sources of information about trials. Advancing age was associated with increased odds of being very willing to participate (ORFQHC=1.03, 95% CI 1.02-1.05; ORCommunity=1.02, 95% CI 1.00-1.04). Qualitative data (6 FGDs, 29 attendees) revealed limited awareness, experimentation/exploitation-based fears, and minimal racial/ethnic representation among trialists as barriers to participation. CONCLUSION: COVID-19 trial participation rates were low in our sample. Altruism was a key facilitator to participation; fear, mistrust, and low awareness were predominant barriers. Community-centered approaches, engaging informed providers and trusted community members, may facilitate inclusive trial participation.

Trusting relationships between patients with non-curative cancer and healthcare professionals create ethical obstacles for informed consent in clinical trials: a grounded theory study.

BACKGROUND: Clinical trial participation for patients with non-curative cancer is unlikely to present personal clinical benefit, which raises the bar for informed consent. Previous work demonstrates that decisions by patients in this setting are made within a 'trusting relationship' with healthcare professionals. The current study aimed to further illuminate the nuances of this relationship from both the patients' and healthcare professionals' perspectives. METHODS: Face-to-face interviews using a grounded theory approach were conducted at a regional Cancer Centre in the United Kingdom. Interviews were performed with 34 participants (patients with non-curative cancer, number (n) = 16; healthcare professionals involved in the consent process, n = 18). Data analysis was performed after each interview using open, selective, and theoretical coding. RESULTS: The 'Trusting relationship' with healthcare professionals underpinned patient motivation to participate, with many patients 'feeling lucky' and articulating an unrealistic hope that a clinical trial could provide a cure. Patients adopted the attitude of 'What the doctor thinks is best' and placed significant trust in healthcare professionals, focusing on mainly positive aspects of the information provided. Healthcare professionals recognised that trial information was not received neutrally by patients, with some expressing concerns that patients would consent to 'please' them. This raises the question: Within the trusting relationship between patients and healthcare professionals, 'Is it possible to provide balanced information?'. The theoretical model identified in this study is central to understanding how the trusting professional-patient relationship influences the decision-making process. CONCLUSION: The significant trust placed on healthcare professionals by patients presented an obstacle to delivering balanced trial information, with patients sometimes participating to please the 'experts'. In this high-stakes scenario, it may be pertinent to consider strategies, such as separation of the clinician-researcher roles and enabling patients to articulate their care priorities and preferences within the informed consent process. Further research is needed to expand on these ethical conundrums and ensure patient choice and autonomy in trial participation are prioritised, particularly when the patient's life is limited.

Clinical research nurse utilisation and role in the conduct of decentralised clinical trials: a literature review.

Background: The decentralised clinical trial (DCT) model has been popularised given its remote or virtual design, permitting expanded participant enrolment into community settings. Clinical research nurses (CRNs) are specially trained in the management of clinical trials; however, the utilisation of the research nurse role relating to decentralised trial conduct is not well-established. Aims: A literature review was conducted to describe the role of the research nurse in the conduct of DCTs and the current utilisation of this nurse specialty for decentralised trial management. Methods: Use of keywords 'DCT' or 'virtual trial' and 'nursing' were used to identify full-text, peer-reviewed literature in the English language and published within the last 10 years that described the clinical research nursing role. Results: Of the 102 pre-screened articles identified across five databases, 11 articles were eligible for full-text analysis. Thematic groupings of common discussion elements included Variance in Decentralised Clinical Trial Model Implementation, CRN Involvement in Decentralised Trial Conduct and Reporting and Shared Challenges of Decentralised Trial Implementation Affecting the CRN Role. Conclusions: Implications of this literature review include expanded trial sponsor awareness of the support requirements to facilitate research nurse utilisation and optimal decentralised trial conduct.

The influence of political ideology on clinical trial knowledge, invitation, and participation among adults in the United States.

BACKGROUND: Clinical trials remain a critical component of medical innovation. Evidence suggests that individuals' political ideologies may impact their health behaviors. However, there is a paucity of literature examining the relationship between political ideologies and clinical trial knowledge and participation. METHODS: Study data were derived from Health Information National Trends Survey 5 Cycle 4 (n = 3300), which was conducted from February to June 2020. We used participants' characteristics to estimate the prevalence of clinical trial knowledge and participation. We used multivariable logistic regressions to investigate whether political ideology had a significant impact on clinical trial knowledge and participation. Jack-knife replicate weights were applied for population-level estimates. RESULTS: Most participants were White (64.2%), earned above US$50,000 (62.4%), and lived in urban areas (88.0%). About 59.2% reported having some knowledge of clinical trials, and only 8.9% had ever been invited to participate in clinical trials. A total of 37.0%, 29.5%, and 33.5% of the population endorsed moderate, liberal, and conservative political viewpoints respectively. In the adjusted logistic regression analysis, compared to conservatives, liberals (adjusted odds ratio, 1.92; 95% confidence interval, 1.31-2.80) and moderates (adjusted odds ratio, 1.43; 95% confidence interval, 1.09-1.88) had significantly greater odds of having knowledge of clinical trials. Also, liberals had higher odds of receiving invitations to participate in clinical trials (odds ratio, 1.76; 95% confidence interval, 1.08-2.85; p = 0.023) and greater odds of trial participation (odds ratio, 3.90; 95% confidence interval, 1.47-10.33; p = 0.007) compared to moderates. CONCLUSIONS: The mechanism underlying the higher rates of clinical trial invitations to liberals is unclear and requires further comprehensive investigation. Similarly, further qualitative studies are needed to understand the attributes that promote knowledge and increased likelihood of clinical trial participation among liberals. This will provide crucial insight to help design interventions that further involve conservatives and moderates in clinical trials and scientific enterprise.

Trend in Clinical Trial Participation During COVID-19: A Secondary Analysis of the I-SPY COVID Clinical Trial.

To analyze the temporal trend in enrollment rates in a COVID-19 platform trial during the first three waves of the pandemic in the United States. DESIGN: Secondary analysis of data from the I-SPY COVID randomized controlled trial (RCT). SETTING: Thirty-one hospitals throughout the United States. PATIENTS: Patients who were approached, either directly or via a legally authorized representative, for consent and enrollment into the I-SPY COVID RCT. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 1,338 patients approached for the I-SPY COVID trial from July 30, 2020, to February 17, 2022, the number of patients who enrolled (n = 1,063) versus declined participation (n = 275) was used to calculate monthly enrollment rates. Overall, demographic and baseline clinical characteristics were similar between those who enrolled versus declined. Enrollment rates fluctuated over the course of the COVID-19 pandemic, but there were no significant trends over time (Mann-Kendall test, p = 0.21). Enrollment rates were also comparable between vaccinated and unvaccinated patients. In multivariable logistic regression analysis, age, sex, region of residence, COVID-19 severity of illness, and vaccination status were not significantly associated with the decision to decline consent. CONCLUSIONS: In this secondary analysis of the I-SPY COVID clinical trial, there was no significant association between the enrollment rate and time period or vaccination status among all eligible patients approached for clinical trial participation. Additional studies are needed to better understand whether the COVID-19 pandemic has altered clinical trial participation and to develop strategies for encouraging participation in future COVID-19 and critical care clinical trials.

Community Health Representatives as Trusted Sources for Increasing Representation of American Indian Communities in Clinical Research.

Indigenous and American Indian Alaskan Native (AI/AN) community members are systematically underrepresented in clinical trial research. This paper focuses on exploratory steps to partner with Native Nations of Arizona to engage Community Health Representatives (CHR) as a trusted source for building COVID-19 clinical trial research, including vaccine trials awareness. CHRs are frontline public health workers who apply a unique understanding of the experience, language, and culture of the population served. This workforce has entered the spotlight as essential to the prevention and control of COVID-19. METHODS: Three Tribal CHR programs were engaged to develop and refine culturally centered educational materials and a pre-post survey using a consensus-based decision-making approach. CHRs used these materials in brief education sessions during regular client home visits and community events. RESULTS: At 30 days post CHR intervention, participants (N = 165) demonstrated significantly increased awareness about and ability to enroll in COVID-19 treatment and vaccine trials. Participants also described a significant increase in trust in researchers, decreased perceived barriers related to cost for participation in a clinical trial, and improved belief that participation in a COVID-19 clinical trial for treatment was considered a benefit to American Indian and Alaskan Native people. CONCLUSION: CHRs as trusted sources of information, coupled with culturally centered education materials designed by CHRs for CHR clients, demonstrated a promising approach to improved awareness of clinical trial research generally and COVID-19 trials specifically among Indigenous and American Indian community members of Arizona.

Virtual Community Engagement for Retention of Black Men in Clinical Research.

Black American men have worse cardiovascular health compared with their White counterparts, yet are highly underrepresented in clinical trials. In 2020, Black men were recruited to participate in Black Impact, a community-based lifestyle intervention to increase cardiovascular health. Due to the research pause during the Coronavirus Disease (COVID-19) pandemic, a virtual community engagement (VCE) process was co-designed with community stakeholders and evaluated for its effect on retention for the clinical trial. VCE via weekly virtual video conference sessions occurred for 9 weeks as a run-in phase prior to in-person research activities. Data collected during sessions included attendance, anecdotes on acceptability, and topical requests for subsequent weeks. Content analysis was performed on scribe notes from sessions to ascertain themes describing the implementation and participant perceptions of the VCE. Descriptive statistics were used to analyze quantitative data. The VCE provided opportunities to co-create a safe atmosphere in small groups, discuss mental health, foster trust, capitalize on the power of spirituality, and establish a brotherhood. Following the VCE run-in phase, 74 of 100 participants remained engaged for participation in the Black Impact study. The VCE described provides a framework that can be used to retain Black men during study delays or disruptions through fostering engagement and building community among participants and researchers.

Patient- reported reasons for non-participation in a COVID-19 therapeutics clinical trial: Findings from a multi-center investigation.

BACKGROUND: Early in the pandemic, there were no evidence-based treatments for SARS-CoV-2, creating an urgent need to identify effective therapeutics. However, public participation in medical research is low; trial enrollment in the US is typically 10-20%. Thus, the aim of this study was to identify common themes underpinning patient reasons to decline participation and evaluate the impact of specific contextual factors. METHODS: This sub-study was conducted in five VISN-1 Clinical Trials Network participating facilities from 4/10/2020-2/3/2021. The trial evaluated the addition of the IL-6-inhibitor, Sarilumab, to the current standard of care for inpatients with moderate-to-severe SARS-CoV-2. Consent procedures varied by site and included fully in-person and fully remote processes. Reasons for declining enrollment were collected among eligible patients who declined to participate but agreed to answer a short follow-up question. Qualitative data were analyzed using directed content analysis. Enrollment rates were assessed using simple, descriptive statistics. RESULTS: N = 417 COVID-19 positive inpatients were screened and 53/162 eligible patients enrolled. Enrollment varied across study sites and by study period. Prior to identification of effective treatment, the enrollment rate was 10/11 (91%) versus 43/144 (30%) during the later period of the study. N = 85/102 patients who did not enroll answered the follow-up question. The most commonly reported responses were: concerns about the study drug and participation in clinical research in general, comorbidity concerns, competing priorities, external factors, and external advice and influence from family members and clinicians. CONCLUSIONS: Identifying reasons behind declining to enroll may help investigators develop strategies to increase research participation.

Clinical trial knowledge among U.S. adults aged 65 years and up: Findings from a 2020 national survey.

BACKGROUND: Older adults are underrepresented in most clinical trials. As the United States observes growth in the number of older adults over time, it will be critical to include them in clinical trials to improve the generalizability of results across age groups. Although clinical trial participation requires clinical trial knowledge, no study has assessed clinical trial knowledge among older adults. Using a national survey, this study aims to identify the prevalence and determinants of clinical trial knowledge among older adults. METHODS: We used the 2020 Health Information National Trends Survey for secondary data analysis. We restricted the sample to older adults (aged 65 years and up). Our outcome variable was whether respondents reported having any clinical trial knowledge. We controlled for demographics, social determinants of health, healthcare utilization, and comorbidities through multivariable logistic regression models. RESULTS: Using a weighted sample of 27,574,958 adults, we estimated that 61.1% of older adults reported having at least some knowledge of clinical trials. After controlling for other factors, those with one to two (OR = 1.80, 95% CI:1.14-2.84) or three to five (OR = 2.93, 95% CI:1.74-4.95) portal visits compared with no portal visits, those with cancer (OR = 1.92, 95% CI:1.22-3.02), and those with depression (OR = 2.27, 95% CI:1.23-4.20) had greater odds of having clinical trial knowledge. Inversely, those with hypertension (OR = 0.62, 95% CI:0.42-0.92) had lower odds of clinical trial knowledge. CONCLUSIONS: Patient portal recruitment may be a supplemental intervention to improve clinical trial knowledge among older adults. Further research on additional interventions for identifying eligible participants is needed to minimize the burden among clinicians amidst other competing demands during clinic visits.

College students' knowledge and attitudes toward clinical trials and their relationship with willingness to participate in COVID-19 trials or vaccines.

OBJECTIVE: We examined clinical trial knowledge and attitudes, and their relationship with willingness to participate in COVID-19 vaccine trials, and willingness to accept a COVID-19 vaccine among college students. PARTICIPANTS: 331 undergraduates: mean age 25; 72% women; and 78% white. METHODS: We administered an online, anonymous survey to undergraduate students in July, 2020, during the COVID-19 pandemic. RESULTS: The mean clinical trial knowledge score was 65% (SD = 16) correct. The mean attitudes toward clinical trials score (1 most negative: 5 most positive) was 3.3 (SD = 0.5). Attitudes toward clinical trials were associated with likelihood of COVID-19 trial participation (positive 76% vs. negative 35%, p = 0.001) and a trend toward likelihood of accepting a COVID-19 vaccine if available (positive 89% vs. negative 67%, p = 0.066). CONCLUSIONS: General clinical trial knowledge and attitudes appear to be important targets for educational interventions. Furthermore, fostering positive attitudes may lead to improved COVID-19 trial participation and vaccine uptake.

The Role of Social Support in Cardiovascular Clinical Trial Participation among Black Men: Black Impact.

BACKGROUND: Attainment of the American Heart Association's Life's Simple 7 (LS7) metrics reduces cardiovascular disease (CVD) risk; yet, Black Americans have the lowest LS7 attainment among all communities, the highest rate of CVD mortality, and low clinical trial participation. Social support is positively correlated with chronic disease self-management. Here, we describe the role of social support in a single-arm pilot clinical trial of a community-based lifestyle intervention among Black American men. METHODS: The 24-week intervention featured weekly team-based physical activity and LS7-themed education. Seventy-four Black men participated in the intervention; twenty agreed to participate in exit surveys via one of three semi-structured focus groups. Data were transcribed verbatim and analyzed using content analysis framed by House's social support framework. RESULTS: Participants reported support from both peers and health coaches. The sub-themes of social support among peers were: (1) acknowledgement, understanding, and validation, (2) inspiration, (3) sense of community, (4) fear of disappointing fellow participants, and (5) group synergy. The sub-themes of social support from the health coaches and study team staff included: (1) contemplation of current health status, (2) racial concordance of health coaches and study team staff, (3) investment of the research team, (4) incentives, (5) access to healthcare providers, and (6) the COVID-19 pandemic. Emotional support was the most frequently discussed theme. CONCLUSIONS: Social support, especially emotional support, from peers and health coaches was a driver of clinical trial participation among participants. The intervention created a positive social environment and decreased medical mistrust. This intervention may provide a framework by which to facilitate clinical trial participation among Black men.

Racial disparities in Black men with prostate cancer: A literature review.

Black men are disproportionately affected by prostate cancer (PCa), with earlier presentation, more aggressive disease, and higher mortality rates versus White men. Furthermore, Black men have less access to PCa treatment and experience longer delays between diagnosis and treatment. In this review, the authors discuss the factors contributing to racial disparities and present solutions to improve access to care and increase clinical trial participation among Black men with PCa. Racial disparities observed among Black men with PCa are multifaceted, evolving from institutional racism. Cultural factors include generalized mistrust of the health care system, poor physician-patient communication, lack of information on PCa and treatment options, fear of PCa diagnosis, and perceived societal stigma of the disease. In the United States, geographic trends in racial disparities have been observed. Economic factors, e.g., cost of care, recovery time, and cancer debt, play an important role in racial disparities observed in PCa treatment and outcomes. Racial diversity is often lacking in genomic and precision medicine studies. Black men are largely underrepresented in key phase 3 PCa trials and may be less willing to enroll in clinical trials due to lack of awareness, lack of diversity in clinical trial research teams, and bias of health care providers to recommend clinical research. The authors propose solutions to address these factors that include educating clinicians and institutions on the barriers Black men experience, increasing the diversity of health care providers and clinical research teams, and empowering Black men to be involved in their treatment, which are keys to creating equity for Black men with PCa. LAY SUMMARY: Prostate cancer negatively affects Black men more than men of other races. The history of segregation and mistreatment in the health care system may contribute to mistrust among Black men. Outcomes are worse for Black men because they are less likely to be screened or to receive treatment for prostate cancer. Black men also are unlikely to participate in clinical research, making it difficult for investigators to understand how Black men are affected by prostate cancer. Suggestions for addressing these differences include teaching physicians and nurses about the issues Black men experience getting treatment and improving how Black men get information on prostate cancer.

Enrollment of adolescent and young adult patients newly diagnosed with cancer in NCI CTEP-sponsored clinical trials before and after launch of the NCI National Clinical Trials Network.

BACKGROUND: Participation of adolescents and young adults (AYAs) in oncology clinical trials is important to ensure adequate opportunities for AYA patients to contribute to, and benefit from, advances in cancer treatment. METHODS: Accrual data for National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) cooperative group-led treatment trials were examined to assess enrollment of newly diagnosed AYA patients (15-39 years) during the period 2004-2019, with particular interest in comparing enrollment before launch of the NCI National Clinical Trials Network (NCTN) to after. All phase 2, 2/3, and 3 trials activated during the period between January 1, 2004, and December 31, 2019, were identified (n = 1568) and reduced to a set of 304 that met predetermined criteria to focus on cooperative group-led trials that involved therapy for newly diagnosed cancer and had age eligibility overlapping the AYA range. The proportion of AYA patients relative to total accrual, along with 95% bootstrapped CI was calculated for patients enrolled pre-NCTN and post-NCTN. RESULTS: AYA accrual comprised 9.5% (95% CI, 7.6-11.8) pre-NCTN compared with 14.0% (95% CI, 9.9-18.3) post-NCTN. The mean difference in proportions post-NCTN compared with pre-NCTN was 4.4% (0.7%-8.3%). CONCLUSIONS: These results indicate an increase in AYA participation in trials conducted within the NCTN relative to the pre-NCTN period. This suggests an awareness and utilization of NCTN trials for AYAs with cancer.