Therapeutic Cancer Clinical Trials Research Articles

Underrepresentation of Asian Americans, Native Hawaiians, and other Pacific Islanders (AA & NHPI) in cancer clinical trials that led to FDA approvals in 2010-2022.

11026 Background: About 6% and 0.3% of the total United States (US) population identify as Asian or NHPI alone, respectively. The most commonly diagnosed cancers among AA & NHPI in the US are breast, prostate, lung, thyroid, and colorectal. Liver, gastric, and head and neck cancers occur in higher rates in AA & NHPI vs. non-Hispanic White. Enrollment of Asian & NHPI patients in multiregional cancer clinical trials may provide additional data regarding intrinsic and extrinsic factors (e.g., diet, infections, environmental exposures) impacting the etiology of cancer. We investigated enrollment trends of NHPI and Asian (within and outside of US) patients in cancer clinical trials that led to an FDA approval from 2010-2022. Methods: We analyzed data from ~98,000 patients in 171 cancer therapeutic clinical trials that led to FDA approvals for breast, prostate, lung, thyroid, colorectal, liver, gastric, and head and neck cancer indications from 2010-2022. Separate race categories of Asian and Native Hawaiian and other Pacific Islander were used. Results: Descriptive statistics of NHPI and Asians within and outside of US enrollment in breast, prostate, lung, thyroid, colorectal, liver, gastric, and head and neck cancer trials that led to an FDA approval from 2010-2022 are summarized in the table. Enrollment of Asian patients in the US was <1% (except for liver cancer) and NHPI patients was <0.2%. Conclusions: Although cancer is the leading cause of death for AA & NHPI, AA & NHPI are under-represented in cancer clinical trials, especially when data are further disaggregated into enrollment of NHPI and Asians within and outside of the US. Cancer etiology may vary in Asians in the US vs. Asia due to different intrinsic/extrinsic risk factors, underscoring the importance of enrolling more AA & NHPI into clinical trials to expand the evidence supporting drug approvals in the US and to advance health equity through clinical trial diversity. [Table: see text]

A Mixed-Method Approach to Explore Successful Recruitment and Treatment of Minority Patients on Therapeutic Cancer Clinical Trials at a Tertiary Referral Center Using Photo-Elicitation Interviews.

Under-represented minority patients (URM) enroll in cancer clinical trials (CCT) at low rates. To gain insight into barriers and facilitators to CCT enrollment, we conducted a mixed method study of URM patients who were successfully treated on a therapeutic CCT from 2018-2021 at all institutional sites. A retrospective chart review of 270 minority patients was conducted to identify patient demographics and characteristics. All living URM patients were requested to participate in a survey and qualitative interview using a photo elicitation technique. Most patients who participated in a CCT were patients with solid tumors, metastatic disease, and did not live in a rural area. Survey data showed that the two most significant drivers of CCT enrollment were potential of benefit to self and to others (altruism). Direct recommendation from a healthcare provider to participate in CCT was critical. URM patients enrolled on a CCT experience a significant burden of symptoms and financial distress. Key themes identified from the interviews that motivated patients to participate included chance for cure, staying positive, altruism and advancement of science, and having diverse representation in research. Patient-level facilitators to participation included social support, cost coverage, and limited treatment options. Sytematic facilitators identified included minimizing logistical barriers, decentralizing cancer clinical trials, increasing awareness via patient narratives, diversifying research staff, minimizing cost, and being clear on puropose and benefit of the trial. Success stories of minority recruitment can provide useful information to enhance minority accrual. Photo elicitation interviews provide rich narratives of patient experience.

Abstract A076: Trial participation in pictures: Using photo elicitation to explore minority patients’ experiences on therapeutic cancer clinical trials

Abstract Background: Much has been published about barriers to research participation for under-represented minority (URM) yet we know little about the experiences, motivations, and decision-making of the URM patients who were successfully treated on clinical trial (CT). The purpose of this study is to draw on the experiences of URM patients as insiders of practical knowledge of CT through photo elicitation to comprehensively understand the current state of recruitment and treatment of URM patients on interventional cancer CTs across the Mayo Clinic enterprise with a short-term goal of informing mechanisms to enrich CT participation and a long-term goal of building a patient-centered cancer practice and clinical trial patient population that is reflective of the diverse communities served by Mayo Clinic. Method: An Appreciative inquiry approach was adapted for this study which acknowledges that existing strengths and everyday experiences of URM patients has the potential to allow a more nuanced view as it pertains to our cancer populations. A total of 138 URM were invited to participate. Using photo elicitation technique, patients were asked to take photographs to portray factors that motivated them and/or facilitated their enrollment, barriers to enrollment and recommendations to improve the process for CT recruitment for other URM. Participant-generated photographs (59) and accompanying 13 interview narratives were analyzed using layered analysis. Results: A total of 13 patients (female =9) participated in the photo interviews. URM detailed their overall experiences around CT participation, motivations for participating in clinical trials; facilitators to clinical trial participation; and opportunities and considerations for increasing minority patients CT participation. Photo analyses provided symbolic representation of patients’ general experiences around CT including celebrating their “new identity”, finding peace in moments of nostalgia, their journey through the trial, lost times and finances and yet finding a new purpose to live through CT participation. Importantly patients described decision making in CT participation as a relational approach. Patients suggested opportunities and considerations for increasing minority patients trial participation, which included minimizing logistical barriers, decentralizing cancer clinical trials, increasing awareness via patient narratives, diversifying research staff, minimizing cost, and being clear on purpose and benefit of the trial. Conclusion: Our study highlights the potential to utilize visual data and narratives from URM in CT recruitment and education programming. It provided valuable insights from the URM community for the URM community on key issues on motivations of CT participation and decision-making in CT participation. Citation Format: Gladys B. Asiedu, Rahma Warsame, Mary O’Shea, Yong-hun Kim, Sara A. Ellingson, Katharine A. Price. Trial participation in pictures: Using photo elicitation to explore minority patients’ experiences on therapeutic cancer clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A076.

Patient-recommended communication strategies to enhance clinical trial participation among Black people with cancer.

106 Background: People racialized as Black and/or African American (AA) represent less than 10% of participants enrolled in therapeutic cancer clinical trials that may improve cancer survival. AAs have higher cancer-related mortality rates but are less likely to be invited to participate in clinical trials compared to their white counterparts. We surveyed Black patients with cancer to assess their clinical trial discussion experiences and to identify opportunities to improve clinical trial participation. Methods: A purposive sample of 100 Black patients from a North Carolina Comprehensive Cancer Center were recruited to complete a survey between November 2021 and January 2023. Survey participants were identified through a clinical data warehouse and had to meet the following eligibility criteria: self-identified Black or AA race, diagnosis of either multiple myeloma, breast, prostate, colon, or lung cancer, and actively receiving or undergoing follow up cancer care. Surveys were conducted by a research assistant via phone. This analysis focused on those asked to participate in a clinical trial but declined participation. Results: All participants identified as Black or AA race with 2 participants additionally identifying as American Indian. Half of all surveyed participants were asked to participate in a clinical trial. Of those asked, 58% (n=29) declined and nearly half (n=12) indicated specific barriers that influenced their decision to not participate. Barriers included time constraints, distrust, fear of being harmed or being used as a guinea pig, not understanding the purpose of the study, and feeling rushed in their clinical trial decision making. All 29 participants were asked to select how they would prefer to receive clinical trial information and 97% selected speaking with their oncologist, 90% by video, 66% by internet and by a pamphlet or magazine, 52% at church and only 10% from a barber shop or salon. They also suggested simple and clear messaging about clinical trial opportunities, eligibility criteria, time commitment, taking time to discuss clinical trial options, and recruitment materials that can be taken home. Conclusions: Increasing participation in cancer clinical trials among Black patients with cancer necessitates careful discussion and consideration of fear, distrust, and system level barriers that influence the decision or capacity to enroll. Study recruitment should utilize patient centered communication tools that acknowledge the history of research exploitation in Black communities and clearly describe safety and security measures used in clinical trials.

Rates of and Factors Associated With Patient Withdrawal of Consent in Cancer Clinical Trials

Patient withdrawal of consent from a cancer clinical trial is defined as a patient's volitional cessation of participation in all matters related to a trial. It can undermine the trial's purpose, make the original sample size and power calculations irrelevant, introduce bias between trial arms, and prolong the time to trial completion. To report rates of and baseline factors associated with withdrawal of consent among patients in cancer clinical trials. This multisite observational cohort study was conducted through the Alliance for Clinical Trials in Oncology. Patient withdrawal was defined as a patient's voluntary termination of consent to participate anytime during trial conduct. Baseline patient- and trial-based factors were investigated for their associations with patient withdrawal within the first 2 years using logistic regression models. All patients who participated in cancer therapeutic clinical trials conducted within the Alliance for Clinical Trials in Oncology from 2013 through 2019 were included. The data lock date was January 23, 2022. The percentage of patients who withdrew consent in 2 years and factors associated with withdrawal of consent. A total of 11 993 patients (median age, 62 years; 67% female) from 58 trials were included. Within 2 years, 1060 patients (9%) withdrew from their respective trials. Two-year rates of withdrawal were 5.7%, 7.6%, 8.5%, 7.8%, 8.4%, 9.5%, and 9.8% for each of the respective years from 2013 through 2019. In multivariable analyses, Hispanic ethnicity (odds ratio [OR], 1.67; 95% CI, 1.30-2.15; P < .001), randomized design with placebo (OR, 1.64; 95% CI, 1.38-1.94; P < .001), and patient age 75 years and older (OR, 1.39; 95% CI, 1.12-1.72; P = .003) were associated with higher likelihood of withdrawal by 2 years. Use of radiation was associated with patient retention (OR, 0.68; 95% CI, 0.54-0.86; P = .001). In this cohort study, rates of withdrawal of consent were less than 10% and appeared consistent over time. Factors that are associated with withdrawal of consent should be considered when designing trials and should be further studied to learn how they can be favorably modified.

Rural communities and health professional shortage areas (HPSA) and access to immune effector cellular therapy and lymphoma/myeloma clinical trials.

e18633 Background: The National Health Service Corps (NHSC) has created a shortage designation to identify medically underserved communities. HPSA (Health Professional Shortage Areas) designation identifies an area, population, or facility with inadequate access to healthcare resources such as primary care. Rural-urban continuum codes (RUCC) classify U.S. census tracts using urbanization, population density, and daily commuting. Additionally, there are racial, ethnic, and geographic disparities in enrollment on therapeutic cancer clinical trials. Chimeric antigen receptor T cell (CAR T) therapy has been at the forefront of immune effector cell therapy (IEC) for lymphoma and myeloma. However, it is delivered at specialized centers, and access to specialty centers is known to be a challenge due to financial and geographic barriers. At our institution, trials for CAR-T cell therapy in lymphoma and myeloma are conducted by the IEC disease working group (DWG), while non-IEC trials are conducted by the lymphoma/myeloma DWG. We hypothesized that patients from HPSA and rural communities and HPSA had lower access to IEC and non-IEC trials for lymphoma and myeloma . Methods: Patients enrolled between 1/1/2015 – 2/6/2023 on IEC and non-IEC interventional trials with treatment were included. Disease types included lymphoma (Follicular lymphoma, high-grade B cell lymphoma, diffuse large B cell lymphoma) and myeloma were included. The hypothesis was tested through a t-test. Results: There were 667 total subjects. 503 (75.4%) were non-IEC and 96 (14.3%) were IEC clinical trial participants. The majority in both groups were male (52.7%), White (74.8%), non-Hispanic (86%) .Only 69 (10.3%) pts were from rural areas and 223 (38.9%) were from HPSA communities When stratifying based on RUCC (Table), there is significantly higher rural accrual for IEC trials compared to non-IEC trials. Hispanics from rural areas were lower. There were no African Americans (AA) from rural areas. Conclusions: There is low representation of patients from HPSA and rural communities for IEC and non-IEC lymphoma and myeloma clinical trials. The ethnic and racial inequity in access and enrollment to lymphoma/myeloma trials are pronounced in rural and HPSA communities. Strategies to improve clinical trial enrollment of the underserved rural and HPSA populations is an area of unmet need and will benefit minorities and patients from lower socioeconomic status. [Table: see text]

"If You Don't Trust Your Doctor That Much...You'd Feel Less Confident Doing a Research Study": Factors Influencing Black Patient Participation in Hematology Trials

Background Racial disparities exist in incidence and survival from hematological cancers. These differences are driven by multiple factors, including disease biology and access to high-quality cancer care (e.g., enrollment in a clinical trial). Black persons constitute 5-7% of participants in therapeutic cancer clinical trials (Bhatnagar et al. 2017, S. Al Hadidi et al. 2020, S. Al Hadidi et al. 2022), despite accounting for 14% of the US population. While previous studies have broadly focused on understanding factors that underpin that disparity in clinical trials, very few have focused explicitly on populations with hematological cancers. Further, research evaluating the perspectives of hematologists on factors that influence clinical trial enrollment for the Black population remains limited. The objective of this study was to understand factors that influenced Black participant enrollment in hematology-focused clinical trials by examining the perspectives of Black patients with multiple myeloma and their hematologists. Methods Between August 2021-January 2022, hematologists were recruited to participate in single semi-structured 60-minute virtual interviews, while patients diagnosed with multiple myeloma were asked to participate in focus group discussions (FGDs) lasting up to 90 minutes via videoconferencing. Through the Sort and Sift, Think, and Shift approach (Maietta et al. 2021),analytic memoing and diagramming of key quotations were used to assess topics and identify larger conceptual themes. We tabled and grouped themes, topics, and associated quotations at multiple levels using the National Institute on Minority Health and Health Disparities Research framework. Topics and themes from FGDs and hematologist interviews were then distilled into key claims. Results We conducted 6 FGDs with 23 patients and 13 semi-structured interviews with hematologists. Hematologists perceived trust at multiple levels (e.g., patient-provider, patient-health care system) as an influential determinant of Black patients' enrollment in clinical trials (Table 1). Factors that fostered patient-hematologist trust included the length of the relationship, use of transparent and empathic communication, and shared racial identities of patients and hematologists. For patients, trust in the hematologist, health care system, and proposed trial intervention were determinants of whether Black patients enrolled in a clinical trial. Patients also emphasized the importance of hematologists acknowledging the historical events that led to the intentional harm of Black persons engaged in research-related activities and recommended additional efforts to foster shared medical decision-making. Some hematologists perceived clinical trial discussions as potentially harmful when building trust in their patient relationships. Hematologists also considered patient context--such as geographic location, socioeconomic challenges, and health literacy along with study eligibility criteria--when deciding to offer a clinical trial (Figure 1). Hematologists also viewed lack of time, trial availability, and adequate clinical trial infrastructure as barriers to discussing and enrolling Black patients in clinical trials. Conclusion Black patients and hematologists perceived trust at multiple levels as critical to enhancing the enrollment of Black participants in hematology-focused cancer clinical trials. Additionally, hematologists' perceptions about patients, including the additional burdens associated with clinical trial participation, also impacted whether or not Black patients are given the opportunity to participate in a clinical trial. Addressing disparities in clinical trial enrollment among Black participants requires multilevel interventions such as 1) fostering patient-clinician relationships, 2) increasing clinical trial availability and partners in community-based settings, 3) providing support to overcome logistical barriers, 4) acknowledging and finding strategies to address physician biases. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Evaluating therapeutic bladder cancer trial disparities in race/ethnicity.

446 Background: Racial clinical trial disparities in bladder cancer outcomes remains a critical problem in the United States. This study sought to examine representation by race and sex among therapeutic bladder cancer clinical trials that informs the standard of care in bladder cancer management. Methods: Published clinical trial data that inform clinical management were identified from the National Comprehensive Cancer Network guidelines and by clinician input from 2009 to 2021. The characteristics of participants, including sex and race, were collected. Clinical trials were categorized by clinical setting: metastatic bladder cancer (MBC), muscle invasive bladder cancer (MIBC), and non-muscle invasive (NMIBC). Bladder cancer incidence by race were collected from the Surveillance, Epidemiology, and End Results (SEER) Program. SEER incidence data by race was compared to the racial/ethnic breakdown of bladder cancer clinical trial participants and evaluated using hypothesis testing (chi-square). Results: A total of 28 clinical trials were assessed, with a pooled sample of 8003 participants. race was reported for 1786 participants. A total of 17 clinical trials did not report race. The population data from SEER details bladder cancer distributions as 89.52% White, 5.80% Black, 0.33% American Indian/Alaska Native, and 4.36% Asian or Pacific Islander. Chi-square analysis demonstrated significant differences in racial representation for MBC (p&lt; 0.0001) and NMIBC (p=0.0423) settings. No significant differences were observed in the MIBC (p= 0.1954) setting. Conclusions: This study observed that the distributions of race in MBC and NMIBC clinical trials are different from that of the population affected by bladder cancer. It is imperative for therapeutic cancer clinical trials to achieve adequate representation to ensure standard of care therapies in bladder cancer management benefits all.[Table: see text]

Broad inclusion leads to maximal value – examining travel costs associated with clinical trial participation

Introduction Acts of social good, like jury service and voting, lead to distributive societal benefits and often come with protections to ensure that everyone can participate. Clinical trial participation is an act of social good, yet it lacks protections or benefits and comes at great personal cost. Methods In this current study, we assessed the indirect costs associated with cancer clinical trial participation among patients enrolled in therapeutic cancer clinical trials at two National Cancer Institute-Designated Comprehensive Cancer Centers as part of a multi-institutional IMPACT (Improving Patient Access to Cancer Clinical Trials) program from January 2018 to August 2020. Results A total of 258 patients received financial reimbursement during the IMPACT program period. The median (interquartile range, IQR) reimbursed total amount (including all cost categories possible) in US dollars is $378 (1123); the median reimbursed amount for each category is $0 (0) as patients typically do not request for reimbursement in all categories. The median amount of requested entries was $713 (1,824) for lodging, $248 (902) for ground transportation, $208 (373) for gas/ parking/ tolls, $1080 (2105) for patient flight, and $1,001 (1793) for companion flight. Average cost per patient attributable to lodging was $342 (standard deviation, SD=1081), ground transportation was $277 (SD=843), gas/parking/tolls was $410 (SD=634), companion flight was $70 (SD=477), and patient flight was $76 (SD=506). Conclusion Our analysis of costs demonstrates that clinical trial participants incur indirect costs to engage in clinical trials, and these costs vary by institution. These data support the notion that clinical trial participants should receive the same protections and benefits that government and employers offer other social goods such as voting or jury service.

Patients’ perceptions of care coordination among NCORP therapeutic clinical trial participants: A matched case-control study.

e13504 Background: Effective coordination of care (CC) is a critical component of high-quality cancer care; however, many patients with cancer continue to receive poorly coordinated care. CC experiences among therapeutic clinical trial (CT) participants are relatively unknown. We examined cancer patients’ perceptions of CC among CT participants using a validated Care Coordination Instrument (CCI). Methods: The study sample (N = 90) consisted of 45 CT participants and 45 matched non-participants from archival data from our prior CC studies. 171 patients who participated in therapeutic cancer clinical trials through the Hawaii Minority/Underserved NCI Community Oncology Research Program (NCORP) between 2015 and 2020 were contacted for study participation, and 26% completed the CCI. The CCI measures overall perceptions of CC and across 3 domains (Communication, Navigation, Operational). Paired t-tests were used to compare overall and domain scores between CT participants and non-participants. The two groups were matched by age, gender, cancer type (breast, GI, other), and clinical stage. Results: Among CT participants, the mean age was 61.7 ( SD = 9.4), and the majority were female (67%) and Asian (56%). The most common cancer types were breast (27%) and GI (16%), with 24% with stage III disease. CT participants reported significantly higher total CC scores than non-participants (62.5 vs. 55.8; p = .0008). Similar trends were found for Navigation ( p = .007) and Operational ( p = .001) domain scores. 29% of CT participants reported receiving high-intensity CC assistance from their clinical research associates (CRAs), and 27% indicated receiving moderate-level CC assistance. Responses to open-ended questions regarding CC revealed that CT participants received assistance with a variety of CC activities from their CRAs, including scheduling appointments and explaining test results and procedures. Conclusions: Patients who participate in therapeutic cancer clinical trials report more positive perceptions of CC compared to non-participants. Qualitative data suggest that significant care coordination support is provided by the clinical research associate. The results underscore the importance of CC support provided by CRAs who may be an unrecognized component of the healthcare delivery team. CC provided by CRAs may contribute to improved quality and value of cancer care for patients enrolled on therapeutic clinical trials.

Abstract PO-276: Lazarex Cancer Foundation (LCF) financial reimbursement programs (FRP) promote equitable access and inclusion among racial/ethnic minorities in therapeutic cancer clinical trials (TCT)

Abstract Background: Out-of-pocket (OOP) costs for TCT participation place an undue burden on many patients particularly patients of low socioeconomic status and are a significant root cause of inequitable access to trials. OOP cost may contribute to the historically low minority participation in TCT of only ~ 5%. Broad diversity in TCT is central in identifying racial/ethnic response to new and novel therapies. LCF has undertaken specific efforts to determine best practices for identifying, engaging, evaluating, and efficiently reimbursing OOP TCT costs such as lodging, ground transportation, and airfare. The original program, Lazarex CARE (LC), is an unstructured nationwide FRP enrolling patients by self-referral or healthcare professional referral. LCF recently initiated IMPACT (Improving Patient Access to Cancer Clinical Trials), a structured institutionally based FRP program, to assess if consistent, culturally appropriate, and intentional interactions at the institutional level will further increase enrollment, retention, and diversity among underserved patients in TCT and assess additional social and cultural barriers to TCT participation. Methods: LC and IMPACT FRPs utilized criteria for reimbursement on a sliding scale of up to seven times the US Federal Poverty Guidelines for patients enrolled in a TCT. Data was analyzed for LC over the period 2015-2020 and for IMPACT at UCSF and USC Norris Comprehensive Cancer Centers (CCC’s) over the period January 2018 through August 2020. Results: From January 2015 through August 2020, LC enrolled 1,614 patients and observed 25% minority participation; Black/AA 8%, Latino/Hispanic 12%, Asian 4%, Multi-ethnic 1%, vs. ~5% nationwide. Additionally, 31% of patients reported household income of &amp;lt;$25,000. Comparison of IMPACT patients (n=377) with LC patients (n=655) from January 2018 – August 2020, indicates higher overall minority participation (63% vs 23%) and lower household income (52% less than $25,000 vs 25%). Minority participation was Black/AA 4%, Latino/Hispanic 42%, Asian 14%, Multi-ethnic 1% for IMPACT and Black/AA 10%, Latino/Hispanic 8%, Asian 3%, Multi- ethnic 1% for LC. Conclusions: While racial/ethnic diversity will be dependent upon local catchment areas this preliminary data suggests that more intentional, structured interactions at the institutional level through IMPACT and the use of culturally appropriate facilitators may have a significant influence on enrollment, retention, and diversity for some of the most understudied and underserved populations. IMPACT is expanding to CCC’s with catchment areas that have a higher percentage of Black/AA to identify causes of lower enrollment for Black/AA and increase TCT participation. Both LC and IMPACT data support the conclusion that universal implementation of reimbursement of OOP costs for TCT participation is fundamental to removing a significant barrier to equitable access and to increasing TCT diversity. Citation Format: Dana L. Dornsife, Hala Borno, Darcy Spicer, Robert G. Johnson. Lazarex Cancer Foundation (LCF) financial reimbursement programs (FRP) promote equitable access and inclusion among racial/ethnic minorities in therapeutic cancer clinical trials (TCT) [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-276.

Abstract PO-036: University of Guam/University of Hawai‘i Cancer Center Partnership: A seventeen-year investment in cancer health equity in Pacific Islanders

Abstract The University of Guam (UOG)/University of Hawai‘i Cancer Center (UHCC) Partnership aims to grow cancer research capacity at UOG, develop cancer health disparities research at UHCC focusing on Pacific Islanders (PI), raise awareness of cancer and cancer prevention in Guam (GU), Hawai‘i (HI) and the United States Associated Pacific Islands (USAPI), and increase the number of cancer and biomedical science researchers of PI ancestry in the US. An infrastructure comprised of 4 principal investigators, over 30 participating faculty, administrative staff, and external and internal reviewers, backed by institutional support and NCI sponsorship, has supported 17 years of research, training, and outreach designed to reduce cancer health disparities and advance health equity among PI in GU, HI, and the USAPI. Since 2009, the Partnership has funded 22 cancer research projects addressing cancer research priorities of global and regional relevance, including cervical cancer and Areca (betel) nut chewing - a traditional practice associated with oral pre/carcinoma, affecting 600 million users worldwide. Over 100 peer-reviewed manuscripts have been published, over 100 abstracts presented, and 21 grants secured. To address the underrepresentation of PI in biomedical sciences, the Partnership has supported and trained 35 graduate scholars; 23 master’s students at UOG and 12 doctoral students at UH. Two PhD graduates are now faculty members at UOG and engaged in cancer health disparities research. UOG’s Micronesian Studies Program offers a cancer health disparities track, developed by the Partnership and tailored for the Pacific region. In addition, UOG/UHCC faculty, junior investigators, and pre/postdocs receive mentorship, career development, and summer research fellowships; since 2015, 16 early career professionals have received support. Outreach projects have explored community-based participatory approaches to cancer prevention. Youth tobacco use prevention and cessation projects in Guam resulted in landmark tobacco control legislation, decreased tobacco use and increased tobacco taxes, which now sustain cancer programs and patient services in Guam including the Guam Cancer Registry. Current outreach efforts aim to increase colorectal cancer screening and HPV vaccination while building knowledge and awareness among physicians serving PI in GU and HI. Dedicated leadership and longstanding partner collaborations led to the first NCI Community Oncology Research Program site in 2019, providing therapeutic cancer clinical trials in Guam. In conclusion, research capacity at UOG has significantly increased, disparities research at UHCC has expanded, underrepresented PI students are pursuing careers in cancer research, and communities have been engaged in research, training and outreach to advance cancer health equity in HI, GU and the USAPI. Supported by NCI grants U54CA143727 and U54CA143728. Citation Format: Rachael T. Leon Guerrero, Margaret Hattori-Uchima, Hali R. Robinett, Carl-Wilhelm Vogel, Neal A. Palafox. University of Guam/University of Hawai‘i Cancer Center Partnership: A seventeen-year investment in cancer health equity in Pacific Islanders [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-036.

Utilization of a multisite financial reimbursement program to promote racial/ethnic diversity and inclusion in therapeutic cancer clinical trials: The iMPACT Study.

85 Background: A lack of racial/ethnic diversity among cancer therapeutic clinical trial (TCT) participants remains a critical problem. The significance of costs, both direct and indirect, associated with cancer TCT participation are increasingly understood. Here, we report findings observed in the IMproving Patient Access to Cancer clinical Trials (IMPACT) study, a pilot feasibility study investigating the feasibility and efficacy of offering a financial reimbursement program (FRP) during cancer TCT discussion with or without additional outreach in improving enrollment and diversity. Methods: Participants for this study were recruited at two Comprehensive Cancer Centers (CCCs) from April to September 2019. Patients were randomized 1:1 to receive a brochure about a FRP at time of consent for a TCT or receive brochure and outreach through a scripted follow-up phone call regarding the FRP. Results: No difference in TCT enrollment was observed between study arms. Among 170 patients approached to participate, 132 (78%) provided consent. The participant mean age was 57 years old (std dev = 14 years). Among participants 57% were male and 49% were white. The remaining major racial/ethnic groups were Black (5%) Asian (13%) and Hispanic (26%). The proportion of non-whites was greater among IMPACT study (43%) compared to CCC TCT (28%) participants. Among FRP participants, 24% reported a household income &lt; $25,000 and 14% from $25,001 to $56,000. Conclusions: This study observed that offering an FRP as part of TCT discussion is feasible and effective at CCCs. An outreach phone call is not required in order to influence enrollment in TCT. FRP recipients are racially/ethnically diverse and low socioeconomic status.

Abstract A081: Trial Library: A pilot study to examine feasibility, acceptability, and preliminary estimates of efficacy for an online clinical trial matching website on patient-prompted conversations for prostate cancer clinical trials

Abstract Background: The ability of clinical trials to effectively translate into therapeutic interventions for the general population can be limited by a lack of representative participants in these trials. There is an acute need to develop informational resources regarding cancer clinical trials that meet the linguistic and literary needs of under-represented and vulnerable populations. Current practices utilize a one-size-fits-all approach that may be inaccessible to a diverse audience. Given the increased utilization of online resources for health information among a diverse patient population and across age groups, we developed a website, called Trial Library, which may serve as a prostate cancer clinical trial matching tool. We hypothesize that use of the Internet-based clinical trial matching tool in clinic will increase the number of patient-initiated conversations with physicians about clinical trial options, and by extension, improve enrollment to therapeutic cancer clinical trials among a diverse participant pool. Procedures/Design/Aims: This is a nonrandomized, nontherapeutic interventional pilot study. The study will be performed in genitourinary medical oncology clinic at UCSF Helen Diller Family Comprehensive Cancer Center. We will measure the feasibility and acceptability of a clinical trial matching tool that includes two unique features: user-validated clinical trial content and navigation schema. We will measure preliminary estimates of efficacy of the online clinical trial matching tool in triggering patient-promoted conversations regarding clinical trials and ultimately clinical trial enrollment. Discussion: Trial Library is designed to be an accessible informational resource for patients from diverse levels of health literacy and English proficiency. This pilot study will provide important preliminary results to inform the design of the website and subsequent testing outside of clinic. Additionally, this website will ultimately serve as a model for clinical trial information that can be translated across tumor types. Note: This abstract was not presented at the conference. Citation Format: Hala T. Borno, Brian Bakke, Anke Hebig Prophet, Yoon-Ji Kim, Jan Yaeger, Jessica Chao, Pelin Cinar, Celia Kaplan, Eric Small, Christy Boscardin, Ralph Gonzales. Trial Library: A pilot study to examine feasibility, acceptability, and preliminary estimates of efficacy for an online clinical trial matching website on patient-prompted conversations for prostate cancer clinical trials [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A081.

Overcoming Barriers: Evidence-Based Strategies to Increase Enrollment of Underrepresented Populations in Cancer Therapeutic Clinical Trials-a Narrative Review.

Disparities in cancer incidence and mortality rates among racial and ethnic minorities (African Americans, Asian Americans, Pacific Islanders, American Indians, and Latinos/Hispanic Americans) in the USA are well documented. Enrollment of underrepresented populations in cancer therapeutic clinical trials, however, is very low. This is true despite federal mandates to ensure accrual rates adequate for analyses and the evidence that the effectiveness of specific therapies and medications varies across ethnic and racial groups. Consequently, cancer clinical decision-making is based on research studies where the majority of research participants are white males, despite the disproportionate cancer burden in racial and ethnic minority groups. To date, there have been multiple reviews detailing the barriers to enrollment for these populations in cancer clinical trials, but a notable lack of research on possible strategies to overcome them. The aim of this narrative review is to summarize the current evidence for effective approaches to increase enrollment of underrepresented minorities in cancer therapeutic clinical trials. These approaches include (1) cultural and linguistic adaptations of marketing materials, (2) the use of patient navigators, and (3) building ongoing community partnerships. The majority of studies reviewed employ multiple improvement strategies simultaneously. Identifying effective approaches to increase enrollment of underrepresented populations in cancer clinical trials is a critical step in reducing persistent disparities in cancer incidence and mortality among racial and ethnic populations.

P1.16-14 Effects of an Artificial Intelligence (AI) System on Clinical Trial Enrollment in Lung Cancer

Clinical trials offer cancer patients access to the latest promising therapies and improve the overall quality and safety of cancer care. However, few patients participate, due in part to the time and effort associated with traditional manual ad hoc screening methods. IBM Watson Health’s Clinical Trials Matching (CTM) is an artificial intelligence (AI) system that employs natural language processing to abstract patient and trial data from unstructured sources and machine learning to match patients to trials. This study compared the clinical trial enrollment rates of lung cancer patients before and after deployment of CTM. CTM was trained for lung cancer and adopted in an academic outpatient oncology clinic using a phased implementation approach beginning July 2018. Clinical trials included ∼42 therapeutic, supportive care, and observational trials. Clinical research coordinators validated Watson-derived clinical trial matches on the day prior to patient clinic visits. Oncologists were provided with a list of potentially eligible trials for each patient to facilitate evaluation at point of care. The average monthly enrollment rates for therapeutic trials were compared 6 months before and after CTM deployment. Average enrollment rates per active clinical trial were reported. Clinical trial matches were validated and delivered to lung oncology providers in 69% (1818/2637) of patients’ visits during the 6-month phased implementation. Enrollment of patients in lung cancer therapeutic clinical trials occurred at a rate of 3.83 patients/month after CTM deployment, as compared to 1.83 patients/month prior to CTM deployment; a 109% enrollment increase. When adjusted for the average number of active clinical trials before (30) and after (39) CTM implementation, the enrollment was 0.097 patients/trial using CTM, compared to 0.061 patients/trial using traditional methods; a 58.4% enrollment increase. Use of IBM Watson Health’s Clinical Trials Matching (CTM) system with screening coordinators facilitated an increase in clinical trial enrollment and promoted awareness of clinical trial opportunities within the lung oncology practice.

Patient navigation and clinical trial participation: A randomized controlled trial design.

BackgroundTo our knowledge, no published studies utilizing a randomized controlled design have examined the efficacy of patient navigation for improving clinical trial enrollment.MethodsThis patient navigation and clinical trial participation study is a randomized controlled trial to assess the effect of a patient navigator on enrollment into therapeutic cancer clinical trials. Participants are randomly assigned to high intensity, patient navigator-delivered patient educational materials (PEM) and needs assessment vs. low intensity patient navigation (patient navigator-delivered patient educational materials [PEM] alone). Discussion: Effective enrollment strategies may include utilization of patient navigators as away to meet individual needs, barriers, and concerns of participants enrolled in clinical trials.

Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials.

Less than 10% of patients enrolled in clinical trials are minorities. The patient navigation model has been used to improve access to medical care but has not been evaluated as a tool to increase the participation of minorities in clinical trials. The Increasing Minority Participation in Clinical Trials project used patient navigators (PNs) to enhance the recruitment of African Americans for and their retention in therapeutic cancer clinical trials in a National Cancer Institute-designated comprehensive cancer center. Lay individuals were hired and trained to serve as PNs for clinical trials. African American patients potentially eligible for clinical trials were identified through chart review or referrals by clinic nurses, physicians, and social workers. PNs provided two levels of services: education about clinical trials and tailored support for patients who enrolled in clinical trials. Between 2007 and 2014, 424 African American patients with cancer were referred to the Increasing Minority Participation in Clinical Trials project. Of those eligible for a clinical trial (N = 378), 304 (80.4%) enrolled in a trial and 272 (72%) consented to receive patient navigation support. Of those receiving patient navigation support, 74.5% completed the trial, compared with 37.5% of those not receiving patient navigation support. The difference in retention rates between the two groups was statistically significant (P < .001). Participation of African Americans in therapeutic cancer clinical trials increased from 9% to 16%. Patient navigation for clinical trials successfully retained African Americans in therapeutic trials compared with non-patient navigation trial participation. The model holds promise as a strategy to reduce disparities in cancer clinical trial participation. Future studies should evaluate it with racial/ethnic minorities across cancer centers.

Increasing minority participation in gynecologic oncology clinical trials through patient navigation

Objectives: African American patients are less likely to enroll in clinical trials than other racial groups. The project “Increasing Minority Participation in Clinical Trials” (IMPaCT) aims to enhance the recruitment and retention of African Americans in therapeutic cancer clinical trials through patient navigation. The objective of this study was to assess the effect of the IMPaCT program on enrollment into gynecologic oncology clinical trials in a racially and socioeconomically diverse National Comprehensive Cancer Network cancer center.

Enrollment onto breast cancer therapeutic clinical trials: A tertiary cancer center experience

BackgroundAdvances in breast cancer prevention, diagnosis, and treatment are in part the result of patient involvement in clinical trials. Despite increases in new clinical research initiatives and trials open to accrual, only 2–3% of women with breast cancer enroll. There is a need to identify the barriers interfering patient accrual. MethodsData were extracted from patients with breast cancer seen for treatment in 2009 retrospectively. Descriptive analysis of patient demographic on enrollment were performed using logistic regression analyses. ResultsOf 418 patients evaluated for treatment, 163 had a trial available; 138 of these were eligible. Eighty (58%) participated in a clinical trial; the remainder declined (24%) or were not presented for a trial by their treating physicians (76%). Age, preferred language, marital status, family history, or race/ethnicity did not predict for enrollment on a therapeutic clinical trial. Patients with stage II or III breast cancer were more likely to be enrolled on a trial compared to patients with stage 0 or I (odds ratio 2.89, 9.17; p=.02, .0005 respectively). ConclusionsEnrollment of breast cancer patients on therapeutic clinical trials was relatively high (58% eligible, 19% overall). Prospective studies observing breast cancer stage, clinical trial design, and inclusion of community based physician practices would add breadth to the understanding of poor accrual to breast cancer clinical trials.