Cancer-related Clinical Trials Research Articles

Abstract 2245: Awareness and participation in cancer-related clinical trials among gastrointestinal cancer survivors

Abstract Despite significant advances in cancer prevention, early detection, and treatment, there is a persistent disparity in cancer outcomes between diverse racial/ethnic groups and medically underserved populations in the United States (US). The underrepresentation of non-white racial/ethnic groups in clinical trials (CTs) poses a critical challenge to cancer research and effective care delivery. The Hispanic/Latino population is one of the fastest-growing ethnic groups in the US and has a high rate of gastrointestinal (GI) cancer. Although Hispanics/Latinos comprise 18.5% of the US population, they have participation rates of only 1% in CTs. We aimed to describe the awareness and participation of Hispanic/Latino GI cancer survivors in cancer-related CTs. We analyzed preliminary data from an ongoing cross-sectional study that examines the social determinants of health (SDOH) associated with participation in cancer-related CTs among GI cancer survivors. As of November 7, 2023, 57 individuals aged ≥ 21 years responded to a survey assessing their awareness and participation in CTs, and other SDOH domains. Descriptive statistics were used to describe the population, including frequencies, percentages, mean, and standard deviation. The participants’ mean age was 62.5 ± 12.3 years, and 56.1% were women. Most had more than a high school education (80.6%). Moreover, 59.7% of the participants had state-sponsored health insurance or Medicaid. Twenty-nine (50.9%) of the participants reported having heard about cancer-related CTs; however, only nine (31.0%) indicated that they knew how to participate in a cancer-related CT. Most of the participants had heard about cancer-related CTs from their doctor, nurse, or other health professionals (41.4%), their family/friends (20.7%), or social media/newspapers (20.7%). Furthermore, 13 (44.8%) had been invited to participate and 11 (84.6%) were eligible and participated in cancer-related CTs. Most of the participants who were eligible and participated in cancer-related CTs (90.9%) indicated that they participated because they knew CTs are important for the development of effective cancer treatments. Our preliminary findings show high levels of awareness among Hispanics/Latinos GI cancer survivors towards CTs; however, it is concerning that only a minority of those who were aware of CTs knew how to participate in them. More efforts are needed to assess the factors and SDOH that impact participation in cancer-related CTs among this population. Additionally, we will continue to recruit participants to assess the relationship between adverse SDOH and their willingness to participate in cancer-related CTs. Citation Format: Mariela Bournigal-Feliciano, Marievelisse Soto-Salgado, Hilmaris Centeno-Girona, Sofía Contreras-Fernández, Karina Torres-Mojica, Virginia Williams, Arnethea L. Sutton, Katherine Tossas, Robert Winn, Marcia Cruz-Correa. Awareness and participation in cancer-related clinical trials among gastrointestinal cancer survivors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2245.

Abstract 2242: Clinical trials knowledge among Hispanic/Latino gastrointestinal cancer survivors in Puerto Rico

Abstract The discovery of innovative cancer prevention and treatment approaches relies on voluntary participation in clinical trials (CTs); however, participation remains low among minorities/ethnic groups. Knowledge of CTs has been reported as a barrier to CT participation. Yet, there is limited understanding regarding CTs knowledge and participation among gastrointestinal (GI) cancer survivors in Puerto Rico (PR). Colorectal cancer is the second leading cause of death in PR, accounting for 13% among men and women. We aimed to describe the knowledge and factors associated with cancer-related CTs among Hispanic/Latino GI cancer survivors in PR. We analyzed preliminary data from an ongoing cross-sectional study targeting Hispanic/Latino GI cancer survivors aged 21+ years in PR. The study employed an interviewer-administered questionnaire to assess participants' awareness, knowledge, and participation in cancer-related CTs, and the social determinants of health (SDoH) associated with CT participation. Descriptive statistics were used to describe the population. Pearson chi-square test or Fisher's exact test were used accordingly to assess significance. A generalized linear model was used to estimate the odds ratios and 95% confidence intervals (CI) for significant variables. As of November 9, 2023, 59 Hispanic/Latino GI cancer survivors had completed the questionnaire. Women accounted for 56% of the sample, and the median age of study participants was 65 years (IQR: 19). Racial identity among participants was primarily white (63%), followed by other races (18%) and African-American (18%). Most participants were in complete or partial remission from cancer (83%). A significant proportion of the respondents reported having at least 12th grade (81%) and an annual income of $20,000 or higher (67%). Most participants (76%) accurately identified the correct definition of a CT. Participants with 12th grade or more had 1.5 (95% CI:1.1-1.9) times the possibility to correctly identify the CT definition compared to to those with less than 12th grade. Similarly, respondents with an annual income equal or higher than $20,000 had 1.4 (95% CI:1.1-1.8) times the possibility to correctly identify the CT definition compared to their counterpart. Furthermore, 93.2% of respondents had a score of at least 80% of correct responses regarding their knowledge of CTs. Although nearly 100% of the respondents knew about CTs, only 20% had participated. Despite a high level of knowledge regarding CTs in PR, a significant gap remains between knowledge and participation. Factors such as education and income might play a role in understanding the CT definition. However, the barriers preventing participation, including SDoH need further exploration. Enhancing participation among Hispanic/Latino GI cancer survivors in PR is essential for advancing cancer research and improving outcomes for this at-risk population. Citation Format: Hilmaris Centeno-Girona, Marievelisse Soto-Salgado, Mariela Bournigal-Feliciano, Sofia F. Contreras-Fernández, Karina Torres-Mojica, Victoria Williams, Arnethea L. Sutton, Katherine Tossas, Robert Winn, Marcia R. Cruz-Correa. Clinical trials knowledge among Hispanic/Latino gastrointestinal cancer survivors in Puerto Rico [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2242.

Abstract C128: Barriers identified by healthcare professionals concerning the participation of people living with HIV in HPV-related cancer clinical trials in Puerto Rico

Abstract OBJECTIVES: Effectively recruiting and retaining participants in clinical trials (CTs) has proven to be a challenge. Identifying and addressing barriers to CTs participation will allow more CTs to reach enrollment targets and generalize results. We aimed to identify the main barriers that healthcare professionals caring for people living with HIV (PLWH) and potential participants have encountered for promotion and participation in ULACNet-101, respectively, in Puerto Rico (PR). METHODS: We analyzed data from two follow-up phone surveys (2 months and 4 months) with healthcare professionals from HIV healthcare organizations in PR that participated in a training activity focused on CTs and patient navigation. The training activity was part of the efforts implemented at PR to enhance the recruitment strategies in ULACNet-101, a CT aimed at preventing HPV-related cancers among PLWH under the California-Mexico-Puerto Rico (CAMPO) Consortium. Healthcare professionals were questioned about the challenges they face while recommending potential participants to ULACNet-101. Additionally, they identified barriers to participation in the study reported by patients. RESULTS: Eighty-two healthcare professionals participated in the training activity (mean age 45±12 years and 72% female). Following the session, 58 (79.5% response rate) and 43 (64.2% response rate) healthcare professionals completed the first and second follow-up call, respectively. Most of the participants from both follow-up calls worked at community-based organizations (74.1% and 72.1%, respectively). In both calls, the most common barriers that healthcare professionals reported to refer patients to ULACNet-101 were that patients did not show interest (32.8% and 44.2%) and they had not found the best time to talk to patients (24.1% and 18.6%). However, a significant number of healthcare professionals (25.9% and 30.3%) stated that there were no impediments to referring patients to ULACNet-101. Regarding barriers reported by patients to participate, most healthcare professionals informed that the CT site is far from where they live (55.2% and 55.8%) and that they have no one to take them to appointments (55.2% and 53.5%). Additional common barriers reported to participation in ULACNet-101 cited by patients included a lack of awareness about CTs (46.6%, first follow-up call) and fear of the procedures (55.8%, second follow-up call). To overcome barriers to participation in ULACNet-101, healthcare professionals provided educational material about CAMPO (93.1% and 94.4%), coordinated an appointment with a physician to clarify doubts (24.1% and 27.8%), and provided CAMPO’ staff contact information (89.7% and 94.4%). CONCLUSION: The reported barriers by healthcare professionals are crucial to understand and enhance the recruitment of PLWH into cancer-related CTs. We anticipate that by addressing these, we will be able to increase the number of participants in ULACNet-101. As a result, this information will be used to guide the implementation of other cancer related CTs for PLWH in PR. Citation Format: Veronica C. Rodriguez. Barriers identified by healthcare professionals concerning the participation of people living with HIV in HPV-related cancer clinical trials in Puerto Rico [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 C128.

Rural research capacity: a co-created model for research success.

The United States' National Institutes of Health (NIH) have long challenged academia to improve clinical trial enrollment, especially in underrepresented populations; inclusive of geography, age, disability status, racial and ethnic minorities. It has been shown that rural and urban residents enrolled in clinical trials have similar outcomes, yet, rural healthcare systems struggle to provide opportunities to rural residents to participate in clinical trials when infrastructure is limited or unsupportive of research programs and/or research staffing levels are insufficient. To fully address the barriers to clinical trial access in rural areas, it is not adequate to simply open more trials. Community receptivity of research as well as organizational and community capacity must be considered. This project was determined by the Oregon Health and Science University's Institutional Review Board to be generalizable research across the chosen counties and was approved to operate under a waiver of written consent. Participants received a cash incentive in appreciation for their time and verbally agreed to participate after reviewing a project information sheet. The research team co-created a community-responsive approach to the receipt, review, and acceptance of clinical trials in a rural community setting. An adapted 5 step Implementation Mapping approach was used to develop a systematic strategy intended to increase the success, and therefore, the number of clinical trials offered in a rural community. The research team and participating rural community members pilot-tested the implementation of a co-designed research review strategy, inclusive of a Regional Cultural Landscape and three co-created project submission and feasibility review forms, with a cancer early detection clinical trial. The proposed clinical trial required engagement from primary care and oncology. Utilizing the research review strategy demonstrated strong researcher-community stakeholder communication and negotiation, which resulted in early identification and resolution of potential barriers, hiring a local clinical research coordinator, and timely trial opening. To the knowledge of the research team, the work described is the first to use a community-engaged approach for creating a clinical trial implementation strategy directly supportive of rural-sitting community stakeholders in receiving, reviewing, and approving cancer-related clinical trials in their community. Participating community members and leaders had the chance to negotiate research protocol changes or considerations directly with researchers interested in conducting a cancer clinical trial in their rural setting.

Abstract 793: Mechanism of interferon induction by cannabidiol (CBD) and analogues in lung cancer cells

Abstract CBD, an FDA approved drug for epilepsy, may have therapeutic potential for other diseases and is currently being tested for efficacy in cancer-related clinical trials. As the literature about CBD, especially in vitro reports, is often contradictory, increasing our understanding of its specific action on a molecular level will allow to determine whether CBD can become a useful therapy or exacerbates specific cancers in a context-dependent manner. Due to its relative lipophilicity, CBD is challenging to dispense at therapeutic concentrations; therefore, one goal is to identify cannabinoid congeners with greater efficacy and reduced drug delivery challenges. We recently showed that CBD activates interferons as a mechanism of inhibiting SARS-CoV-2 replication in lung carcinoma cells. As factors produced by the innate immune system, interferons have been implicated in both pro-survival and growth arrest and apoptosis signaling in cancer. Here we show that CBD induces interferon production and interferon stimulated genes (ISGs) through a mechanism involving NRF2 and MAVS in lung carcinoma cells. We also show that CBDV, which differs from CBD by 2 fewer aliphatic tail carbons, has limited potency, suggesting that CBD specifically interacts with one or more cellular proteins rather than having a non-specific effect. We also identified other CBD-related cannabinoids that are more effective at inducing ISGs. Taken together, these results characterize a novel mechanism by which CBD activates the innate immune system in lung cancer cells and identify related cannabinoids that have possible therapeutic potential in cancer treatment. Citation Format: Leticia Stock, Lydia Robinson-Mailman, Long C. Nguyen, Shao-Nong Chen, Guido F. Pauli, Marsha R. Rosner. Mechanism of interferon induction by cannabidiol (CBD) and analogues in lung cancer cells [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 793.

Practical Aspects of Implementing and Applying Health Care Cloud Computing Services and Informatics to Cancer Clinical Trial Data.

Cloud computing has led to dramatic growth in the volume, variety, and velocity of cancer data. However, cloud platforms and services present new challenges for cancer research, particularly in understanding the practical tradeoffs between cloud performance, cost, and complexity. The goal of this study was to describe the practical challenges when using a cloud-based service to improve the cancer clinical trial matching process. We collected information for all interventional cancer clinical trials from ClinicalTrials.gov and used the Google Cloud Healthcare Natural Language Application Programming Interface (API) to analyze clinical trial Title and Eligibility Criteria text. An informatics pipeline leveraging interoperability standards summarized the distribution of cancer clinical trials, genes, laboratory tests, and medications extracted from cloud-based entity analysis. There were a total of 38,851 cancer-related clinical trials found in this study, with the distribution of cancer categories extracted from Title text significantly different than in ClinicalTrials.gov (P < .001). Cloud-based entity analysis of clinical trial criteria identified a total of 949 genes, 1,782 laboratory tests, 2,086 medications, and 4,902 National Cancer Institute Thesaurus terms, with estimated detection accuracies ranging from 12.8% to 89.9%. A total of 77,702 API calls processed an estimated 167,179 text records, which took a total of 1,979 processing-minutes (33.0 processing-hours), or approximately 1.5 seconds per API call. Current general-purpose cloud health care tools-like the Google service in this study-should not be used for automated clinical trial matching unless they can perform effective extraction and classification of the clinical, genetic, and medication concepts central to precision oncology research. A strong understanding of the practical aspects of cloud computing will help researchers effectively navigate the vast data ecosystems in cancer research.

Influence of Treatment Facility Type and Annual Patient Volume on Overall Survival in Patients with Mantle Cell Lymphoma: A National Cancer Database Analysis

Influence of Treatment Facility Type and Annual Patient Volume on Overall Survival in Patients with Mantle Cell Lymphoma: A National Cancer Database Analysis

False Positive Cardiotoxicity Events in Cancer-Related Clinical Trials: Risks Related to Imperfect Noninvasive Parameters

Purpose: Cardiac ultrasound provides important structural and functional information that makes identification of cardiac abnormalities possible. Left ventricular ejection fraction (LVEF) provides the most commonly used parameter for recognition of treatment-related cardiac dysfunction. Random reading variance and physiologic factors influence LVEF and make the reported value imperfect. We attempt to quantitate the likelihood of false positive events by computer simulation. Methods: We simulated four visits on hypothetical trials. We assumed a baseline LVEF of 55% and normal distribution with regard to reading error and physiologic variation. 1,000 trials of sample size 1,500 were simulated. In a separate simulation, 1,000 patients entered with LVEFs of 45, 43, and 41% to estimate true positive incidence. Results: At each examination, less than 1.0% of false positives were noted. The cumulative false positive rate over four visits was 3.60%. True cardiotoxicity identification is satisfactory only when LVEF declines substantially. Conclusion: A 3.60% false positive rate in trials where the expected level of toxicity is low suggests that false positives are troubling and may exceed true positive results. Strategies to reduce the number of false positive results include making confirmatory studies mandatory. Evaluating increases along with decreases obtains some estimation of variance.

Targeting invadopodia for blocking breast cancer metastasis.

Dissemination of cancer cells from the primary tumor and their spread to distant sites of the body is the leading cause of mortality in metastatic cancer patients. Metastatic cancer cells invade surrounding tissues and blood vessels by forming F-actin-rich protrusions known as invadopodia, which degrade the extracellular matrix and enable invasion of tumor cells through it. Invadopodia have now been observed in vivo, and recent evidence demonstrates direct molecular links between assembly of invadopodia and cancer metastasis in both mouse models and in human patients. While significant progress has been achieved in the last decade in understanding the molecular mechanisms and signaling pathways regulating invadopodia formation and function, the application of this knowledge to development of prognostic and therapeutic approaches for cancer metastasis has not been discussed before. Here, we provide a detailed overview of current prognostic markers and tests for cancer metastasis and discuss their advantages, disadvantages, and their predicted efficiency. Using bioinformatic patient database analysis, we demonstrate, for the first time, a significant correlation between invadopodia-associated genes to breast cancer metastasis, suggesting that invadopodia could be used as both a prognostic marker and as a therapeutic target for blocking cancer metastasis. We include here a novel network interaction map of invadopodia-associated proteins with currently available inhibitors, demonstrating a central role for the recently identified EGFR-Pyk2-Src-Arg-cortactin invadopodial pathway, to which re-purposing of existent inhibitors could be used to block breast cancer metastasis. We then present an updated overview of current cancer-related clinical trials, demonstrating the negligible number of trials focusing on cancer metastasis. We also discuss the difficulties and complexity of performing cancer metastasis clinical trials, and the possible development of anti-metastasis drug resistance when using a prolonged preventive treatment with invadopodia inhibitors. This review presents a new perspective on invadopodia-mediated tumor invasiveness and may lead to the development of novel prognostic and therapeutic approaches for cancer metastasis.

Statistical controversies in cancer research: using standardized effect size graphs to enhance interpretability of cancer-related clinical trials with patient-reported outcomes

Patient reported outcomes (PROs) are becoming increasingly important in cancer studies, particularly with the emphasis on patient centered outcome research. However, multiple PROs, using different scales, with different directions of favorability are often used within a trial, making interpretation difficult. To enhance interpretability, we propose the use of a standardized effect size graph, which shows all PROs from a study on the same figure, on the same scale. Plotting standardized effects with their 95% confidence intervals (CIs) on a single graph clearly showing the null value conveys a comprehensive picture of trial results. We demonstrate how to create such a graph using data from a randomized controlled trial that measured 12 PROs at two time points. The 24 effect sizes and CIs are shown on one graph and clearly indicate that the intervention is effective and sustained.

Abstract 541: A comprehensive analysis delineating the immunotherapeutic terrain of cancer-related clinical trials

Abstract Technological innovations have facilitated a greater understanding of how the tumor microenvironment contributes to cancer, leading to rapid FDA approval of four immunotherapies. To assess how these therapies are being further investigated in combination with other therapies and in tumor types outside of the current FDA approval, we performed a comprehensive analysis of the curated clinical trials in the JAX Clinical Knowledgebase (JAX-CKB). In brief, clinical trials investigating Atezolizumab, Nivolumab, Pembrolizumab, and Ipilimumab, curated from clinicaltrials.gov, were queried in the JAX-CKB and then analyzed for comparison. Further analyses were executed to illustrate possible unmet needs within the field of cancer therapeutics. Of the four immunotherapies, Pembrolizumab was identified with the greatest number of clinical trials overall, with 305 compared to Atezolizumab, 79, Nivolumab, 183, and Ipilimumab, 126. Of these trials the number of trials investigating Pembrolizumab, Atezolizumab, Nivolumab, or Ipilimumab in combination with another therapy was higher than those investigating one of the four immunotherapies as a monotherapy. Phase II trials for both single therapy and combinatorial therapies were greater than both Phase I and Phase III for the same groups, regardless of therapy. On average, 12% ± 3.8% of the combined trials for all four drugs included any advanced solid tumor. Nivolumab combined with Ipilimumab demonstrated the greatest number of trials (61) investigating an immunotherapy in combination with another immunotherapy. Among those, 30 were Phase II trials, 16 were Phase I, and 14 were Phase III. Across five cancer indications (lung, pancreatic, ovarian, prostate, and colon), lung cancer was most commonly indicated in the trials, among all four drugs. Prostate was indicated in the least number of trials, with Ipilimumab ranking the highest (10). The recent success with immunotherapies has garnered significant interest in understanding how these therapies will perform in different tumor types and whether specific combinations will have a greater impact. Interrogation of the clinical trial terrain in the JAX-CKB provides a basis for determining additional investigations that might be warranted. Citation Format: Cara M. Statz, Sara E. Patterson, Taofei Yin, Susan M. Mockus. A comprehensive analysis delineating the immunotherapeutic terrain of cancer-related clinical trials [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 541. doi:10.1158/1538-7445.AM2017-541

Abstract C03: Randomized controlled trial to increase anal cancer clinical trial recruitment among persons living with HIV/AIDS in Puerto Rico: Methodology and baseline assessment

Abstract Introduction: Anal cancer is more frequent among people living with HIV/AIDS (PLWHA), with incidence rates increasing among PLWHA despite effective HIV treatments. This highlights the need for effective anal cancer screening guidelines. As part of the development of such guidelines for anal cancer prevention, participation and retention in clinical trials (CT) is pivotal. Previous studies showed lower participation of Hispanics in cancer-related CT among PLWHA. We are conducting a randomized controlled trial (RCT) aimed to test the effectiveness of an educational intervention in recruiting PLWHA in one of the anal cancer-related CT of the AIDS Malignancy Consortium (AMC) being conducted in Puerto Rico (PR), the Anal Cancer Prevention Study (ANCHOR). This work describes the methodology of this study and baseline characteristics of study participants. Methods: A collaboration in the development of an educational linear video for anal cancer was conducted in 2015 between UC Davis Comprehensive Cancer Center and the University of Puerto Rico (UPR) Comprehensive Cancer Center. As a result, a RCT is being conducted at the 9 immunology/STI clinics of the PR Department of Health, to test the effectiveness of this audiovisual intervention in increasing: (1) HIV/AIDS patients' knowledge of anal cancer and CT; (2) favorable attitudes towards CT; and (3) willingness to participate in ANCHOR, a CT aimed to developing anal cancer screening and treatment guidelines for PLWHA. Our RCT is expected to recruit 308 PLWHA aged ≤ 35 years, that receive HIV care at these clinics, and that have not participated in any cancer CT or have been diagnosed with any cancer type in their lifetime. The randomization of this study is at the clinic level, in which we randomly allocated each clinic to either: the intervention group (receiving the audiovisual educational intervention focused on CT and anal cancer screening) or the control group (receiving a standard CT recruitment education). Participants who agree to participate complete an informed consent, a baseline survey, and an initial contact survey through a face-to-face computer-based interview. Participants are followed-up at 2-weeks (by phone) and 3-months (at the clinic) in order to assess changes in willingness to participate in anal cancer CT and to determine if the participant has called, been screened, or been enrolled into an AMC CT. Results: As of Mid-June 2016, 134 patients had been screened, 125 (93%) PLWHA were eligible, and 124 of them (99%) agreed to participate in the study. Of the recruited participants, the mean age was 55±10 years, 60% were men, 56% had ≤12 years of education, and 96% had an annual family income ≤ $35,000. Close to half (44%) of the participants reported never having heard about CT, while most (84%) could not correctly identify the definition of a CT. Although 98% of participants thought that participating in an anal cancer CT could be beneficial for their health, 91% had never heard of a high-resolution anoscopy (HRA) and 26% were not interested in participating in a CT that used HRA. Among those not interested in participating in a CT that used HRA, the most common reasons reported were: lack of information provided about the study (87%), and fear to the procedure (6%). Conclusions: Preliminary data at the baseline interview showed a high willingness of PLWHA to participate in anal cancer CT; however, there is a lack of knowledge about anal cancer CT and CT in general. The methodology developed as well as the information obtained will be necessary to develop specific strategies to increase knowledge and awareness about anal cancer and anal cancer CT among PLWHA and promote the advance of RCT for cancer prevention among PLWHA. Citation Format: Vivian Colon-Lopez, Omar Valentin-Rivera, Marievelisse Soto-Salgado, Darilyn Rivera, Julie H. Dang, DA Letran, Moon Jr Chen, Ana Patricia Ortiz. Randomized controlled trial to increase anal cancer clinical trial recruitment among persons living with HIV/AIDS in Puerto Rico: Methodology and baseline assessment. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr C03.

SC31.02 The Role of Patient Advocacy Groups

The role of Patient Advocacy organizations in the oncology health care delivery ecosystem is ever evolving and has moved well beyond its original role of solely advocating for services, research, care and understanding. The current field of patient advocacy has its roots in the patient rights movement of the 1970’s with groups like The National Welfare Rights Organization being instrumental in getting a patient bill of rights accepted by the Joint Commission on Accreditation of Healthcare Organizations in 1972.1 The transformation was further accelerated in 1991 with the formation of the FDA Patient Representative Program and has continued to expand over time with patient advocates now being involved in the entire care continuum. In this presentation I will focus my attention on examples of the ever evolving and expanding role of patient advocacy highlighted by projects developed and led by “partner” foundations the Bonnie J. Addario Lung Cancer Foundation (ALCF) and the Addario Lung Cancer Medical Institute (ALCMI). The disparities in lung cancer treatment and outcomes among underserved populations are well documented.2 Further, 80% of cancer patients are treated in the community hospital setting yet may not receive the same level of care as those treated at leading academic centers. The ALCF Community Hospital Centers of Excellence (COE) program addresses this unmet need. The COE program is a patient-centric model for lung cancer that establishes a standard of care for community hospitals which often treat underserved patient populations. The COE program, which currently includes 13 hospitals in regions of high unmet need, aims to improve the standard of care, patient experience and patient outcome by offering patients and caregivers the same type of multi-disciplinary and comprehensive care provided at leading academic centers. ALCF also provides lung cancer education and services to patients, caregivers and the community. The COE program tracks patient process data longitudinally for multiple quality-of-care metrics, including disease stage at diagnosis; molecular testing; tumor board review; time from diagnosis to treatment; treatment type; and clinical trial participation. Site data will also be monitored to provide a contextual picture of the program including total patients seen, demographics, insurance mix, rates and outcomes of molecular testing among other metrics. Data is analyzed across the COE community and against comparator groups to demonstrate impact of the COE program.3 The U.S. National Institutes of Health database currently lists over 45,000 cancer-related clinical trials worldwide.4 Unfortunately, more than 20% of these trials will never complete, for reasons unrelated to the effectiveness of the intervention that’s being tested. The most common reason for 20% of all clinical trials never finishing is poor patient accrual. One of the most common reasons for low accrual is procedural inefficiencies such as complexities in enrolling in the trial itself and the informed consent process. In 2014, ALCMI launched a prospective study to characterize somatic and germline genomics of adolescents and young adult (AYA) patients.5 It is estimated that less than 2% of those newly diagnosed with lung cancer globally are AYA, thus presenting a striking recruitment challenge. To address this challenge, ALCMI's study workflow included building a dedicated website3 enabling remote screening and e-consenting so patients could participate from their homes anywhere in the world while, in parallel, ALCF employed social media to educate patients on the importance of comprehensive genomic profiling and increasing awareness of the study via grass-roots patient blogging. Together, ALCMI and ALCF bring “research to the patient.” Accrual opened July 23, 2014 and in the first 5 weeks of the study, 37 subjects consented. Of the 37 initially consented, 35 enrolled via the remote web-portal. As of June 15 2016, 104 subjects are enrolled (128 consented) in the study from 10 countries following a social media campaign. Of the 104 subjects enrolled to date, 49% entered the study via the remote study portal with the balance recruited locally by participating ALCMI study sites. As briefly outlined above, patient advocacy organizations have moved well beyond their original patient supportive role and have become key players in the oncology healthcare delivery and clinical research ecosystems. As the healthcare system continues to evolve and become more complex so will the role of patient advocacy organizations. To address these challenges, there will be even greater need for innovation, sharing of data and resources, increased infrastructure and mission sophistication, the need to avoid overlap and duplication, and a laser focus on providing meaningful improvement in the availability, transparency and affordability of healthcare.

Quality and accessibility of oncology-related clinical trials information: A content analysis of Internet media.

6547 Background: The Internet is a communication tool that may be used to improve awareness of and access to cancer-related clinical trials; however, few data characterize how the Internet may encourage clinical trial education and accrual. Methods: In January of 2013, we simulated the experience of a user without knowledge of clinical trials by simply searching “breast cancer treatment”; “lung cancer treatment”; “MDS treatment”; and “prostate cancer treatment” in three popular search engines (Google, Bing, and Yahoo). The top ten unsponsored websites for each were recorded, after eliminating news articles and duplications. Sites were independently evaluated for quality and accessibility by two coders, and discordant data were resolved by consensus. Differences in content by disease type were evaluated using Fisher’s exact tests. Results: The searches yielded 40 unique websites. Before consensus, inter-observer agreement ranged from 75% to 100% (average kappa .67). Overall, 85% of the sites (95% CI: 70% to 94%) mentioned clinical trials on the landing page. Selected measures of quality and accessibility are detailed in the table. Lung cancer and MDS sites were less likely to have interactive features as compared to breast and prostate cancer sites (20% vs. 82%, p=0.004). Conclusions: These data suggest that basic clinical trial information is widely available for naive users searching for cancer treatment information. The quality of that information is highly variable, with only about three-quarters of sites defining clinical trials, one-half providing information about the benefits and risks of enrollment, and only one third of sites Health on Net certified. Moreover, for certain cancers, few sites offer interactive features to facilitate access to information about relevant clinical trials. [Table: see text]

The Development of a Minority Recruitment Plan for Cancer Clinical Trials.

Cancer does not occur in all ethnic and racial groups at similar rates. In addition, responses to treatment also vary in certain ethnic and racial groups. For Hispanics, the overall cancer incidence is generally lower yet for some specific tumor types, the incidence rates are higher compared to other populations. Although disparities are recognized for treatment outcomes and prevention methodologies for Hispanics and other minority populations, specific recruiting and reporting of minorities remains a challenge. In order to circumvent this problem, the Cancer Therapy and Research Center (CTRC) has developed a new minority recruitment plan for all cancer related clinical trials at this Institute. The overall goal of this initiative is to increase the accrual of minorities in cancer clinical trials by implementing several key interventions. The Cancer Therapy & Research Center (CTRC) at the University of Texas Health Science Center at San Antonio established the Clinical Trials Accrual Task Force to develop and monitor interventions designed to increase accrual to cancer clinical trials, specifically the accrual of minorities with a focus on the Hispanic population that makes up 68% of the CTRC's catchment area. A Minority Accrual Plan (MAP) was implemented in March 2013 as part of the process for initiating and conducting cancer-related clinical trials at the CTRC. The Minority Accrual Plan focuses on Hispanic enrollment due to the characteristics of the South Texas population served by the CTRC but could be easily adapted to other populations. The CTRC has designed a process to prospectively address the challenge of deliberately enrolling minority subjects and accurately accounting for the results by implementing a Minority Accrual Plan for every cancer-related clinical trial at CTRC.

Cancer Trials Fail to Track Tobacco Use

Abstract A study of 155 cancer-related clinical trials shows that few asked participants about their tobacco use, limiting our understanding of how continued use may affect treatments and outcomes.

Targeting PI3 Kinase/AKT/mTOR Signaling in Cancer

The phosphatidylinositol 3 kinase (PI3K) pathway is one of the major pathways modulating cell growth, proliferation, metabolism, survival, and angiogenesis. Hyperactivation of this pathway is one of the most frequent occurrences in human cancer and is thus an obvious target for treatment of this disease. Currently there are 26 novel compounds targeting the PI3K pathway being assessed in more than 150 cancer-related clinical trials. Although this pathway is involved in many vital biologic functions, data emanating from these clinical trials indicate that these drugs are well tolerated. This review outlines the interaction of the PI3K pathway with other signaling cascades, highlights mechanisms involved in hyperactivation, discusses current therapeutics in cancer-related clinical trials that target this pathway, and, based on preclinical data, discusses possible leads on patient selection and combinational therapy, including targeting multiple components of the associated signaling network.

Does Increased Patient Awareness Improve Accrual Into Cancer-Related Clinical Trials?

Oncology literature cites that only 2% to 4% of patients participate in research. Up to 85% of patients are unaware that clinical trials research is being conducted at their treatment facility or that they might be eligible to participate. It was hypothesized that patients' satisfaction with information regarding clinical trials would improve after targeted educational interventions, and accruals to clinical trials would increase in the year following those interventions. All new patients referred to the cancer center over a 4-month period were mailed a baseline survey to assess their knowledge of clinical research. Subsequently, educational interventions were provided, including an orientation session highlighting clinical trials, a pamphlet, and a reference to a clinical trials Web site. A postintervention survey was sent to the responders of the initial survey 3 months after the initial mailing. Patient satisfaction with information significantly increased after the interventions. There was no increase in subsequent enrollment in clinical trials. Patients who indicated an inclination to participate in clinical trials tended to have greater satisfaction with the information they received. A set of educational interventions designed for cancer patients significantly improved their satisfaction with information on clinical research, but did not improve clinical trial enrollment of these participants as of 1 year after the study. The development of educational interventions may be justified, but such interventions may require prolonged implementation to establish benefit. Information relating to research may be most effectively delivered by patients' primary cancer care providers.

Early stopping rules in oncology: Considerations for clinicians

The number of cancer-related clinical trials has been rapidly increasing over the past decade. Along with this increase, oncology studies stopped early for benefit or harm have also been more common. Clinicians treating cancer patients often are faced with the challenge of having to decide whether or not to incorporate information from these new studies into their daily clinical practice. This review article explains the role of the Data and Safety Monitoring Committee in stopping trials early; provides examples of oncology trials stopped early; and reviews some of the controversies and statistical concepts associated with early stopping rules. In addition, a simple and practical approach to interpreting the findings of trials that are stopped early is provided to assist clinicians in deciding how to incorporate information from these studies into their daily practice.

Abstract A44: Minority enrollment to clinical trials: Experience at the Dan L. Duncan Cancer Center

Abstract Background: The Dan L Duncan Cancer Center (DLDCC) is located in Houston, Texas, and provides care to uninsured and minority patients in several large hospitals including Ben Taub General Hospital, The Michael E. DeBakey VA Medical Center, and Texas Children's Hospital. The catchment area for the DLDCC is Harris County, an urban area with a population of nearly 4 million; approximately 18% of county residents are African American and 39% are Hispanic. While the percentage of African Americans in Harris County is nearly equal in all age groups, Hispanics make up nearly 45% of residents less than 30 years old, but only 10% of residents over 60, those most likely to develop cancer. One-third of the county population has no health insurance. Objective: In 2006 the DLDCC set out to increase overall enrollment to therapeutic clinical trials while maintaining enrollment of patients belonging to racial and ethnic minorities. Methods: A four-pronged strategy was used to maintain and improve accrual of racial and ethnic minority patients to cancer-related clinical trials while increasing overall accrual. First, the DLDCC invested significant resources in establishing research infrastructure in the hospitals including hiring bilingual coordinators and nurses, translating consents into Spanish, and underwriting the cost for conduct of NCI-sponsored trials. Second, the DLDCC partnered with hospitals to make office space available for research personnel, to provide discounted investigational pharmacy services and to obtain access to laboratory and imaging data and pathology samples. Third, the DLDCC introduced programs to make minority residents aware of clinical trials and build relationships and trust in the community including the establishment of a community advisory board, sponsorship of plays by minority playwrights that carry a cancer message, sponsorship of community health events, and creation of clinical trials newsletters and websites. Finally, the DLDCC pioneered and gained IRB approval for a form designed to collect accurate racial and ethnic data from trial participants. Results: Overall enrollment to DLDCC therapeutic clinical trials increased by more than 50% between 2005/2006 and 2009 to an average of 13.4% of new cancer patients enrolled on trial. In 2009, 16.8% of subjects enrolled to therapeutic trials were African American, and 35.4% were Hispanic. Accrual of minority subjects was equivalent in pediatric and adult programs and on therapeutic and nontherapeutic trials. Conclusion: Recruitment of pediatric and adult members of underserved minorities to clinical trials is possible with targeted strategies, dedicated research staff, hospital partnership and community involvement. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):A44.