Clinical Trial Participation and Time to Treatment Among Adolescents and Young Adults With Cancer: Does Age at Diagnosis or Insurance Make a Difference?

Purpose Because adolescent and young adult (AYA) patients with cancer have experienced variable improvement in survival over the past two decades, enhancing the quality and timeliness of cancer care in this population has emerged as a priority area. To identify current trends in AYA care, we examined patterns of clinical trial participation, time to treatment, and provider characteristics in a population-based sample of AYA patients with cancer. Methods Using the National Cancer Institute Patterns of Care Study, we used multivariate logistic regression to evaluate demographic and provider characteristics associated with clinical trial enrollment and time to treatment among 1,358 AYA patients with cancer (age 15 to 39 years) identified through the Surveillance, Epidemiology, and End Results Program. Results In our study, 14% of patients age 15 to 39 years had enrolled onto a clinical trial; participation varied by type of cancer, with the highest participation in those diagnosed with acute lymphoblastic leukemia (37%) and sarcoma (32%). Multivariate analyses demonstrated that uninsured, older patients and those treated by nonpediatric oncologists were less likely to enroll onto clinical trials. Median time from pathologic confirmation to first treatment was 3 days, but this varied by race/ethnicity and cancer site. In multivariate analyses, advanced cancer stage and outpatient treatment alone were associated with longer time from pathologic confirmation to treatment. Conclusion Our study identified factors associated with low clinical trial participation in AYA patients with cancer. These findings support the continued need to improve access to clinical trials and innovative treatments for this population, which may ultimately translate into improved survival.

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Overcoming Barriers to Clinical Trial Enrollment

American Society of Clinical Oncology Educational Book ◽

10.1200/edbk_243729 ◽

2019 ◽

pp. 105-114 ◽

Cited By ~ 11

Author(s):

Ryan D. Nipp ◽

Kessely Hong ◽

Electra D. Paskett

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Treatment Strategies ◽

Trial Participation ◽

Routine Practice ◽

Clinical Trial Participation ◽

Eligibility Criteria ◽

Financial Barriers ◽

Patients With Cancer ◽

Clinical Trial Enrollment

Clinical trials are imperative for testing novel cancer therapies, advancing the science of cancer care, and determining the best treatment strategies to enhance outcomes for patients with cancer. However, barriers to clinical trial enrollment contribute to low participation in cancer clinical trials. Many factors play a role in the persistently low rates of trial participation, including financial barriers, logistical concerns, and the lack of resources for patients and clinicians to support clinical trial enrollment and retention. Furthermore, restrictive eligibility criteria often result in the exclusion of certain patient populations, which thus adds to the widening disparities seen between patients who enroll in trials and those treated in routine practice. Moreover, additional factors, such as difficulty by patients and clinicians in coping with the uncertainty inherent to clinical trial participation, contribute to low trial enrollment and represent key components of the decision-making process. Specifically, patients and clinicians may struggle to assess the risk-benefit ratio and may incorrectly estimate the probability and severity of challenges associated with clinical trial participation, thus complicating the informed consent process. Importantly, research has increasingly focused on overcoming barriers to clinical trial enrollment. A promising solution involves the use of patient navigators to help enhance clinical trial recruitment, enrollment, and retention. Although clinical trials are essential for improving and prolonging the lives of patients with cancer, barriers exist that can impede trial enrollment; yet, efforts to recognize and address these barriers and enhance trial enrollment are being investigated.

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Disparities in clinical trials participation in a vertically integrated care delivery system.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.128 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 128-128

Author(s):

Ahmed Megahed ◽

Gary L Buchschacher ◽

Ngoc J. Ho ◽

Reina Haque ◽

Robert Michael Cooper

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Healthcare System ◽

Care Delivery ◽

Trial Participation ◽

Cancer Type ◽

Clinical Trial Participation ◽

Integrated Healthcare ◽

Clinical Trial Enrollment ◽

Asian Pacific

128 Background: Sparse data exists on the diversity clinical trial enrollment in community settings. This information is important to ensure equity of care and generalizability of results. Methods: We conducted a retrospective cohort study of members of an integrated healthcare system diagnosed with invasive malignancies (excluding non-melanoma skin cancers) between 2013-2017 to examine demographics of the oncology population compared to those who enrolled in a clinical trial. Logistic regression was used to assess correlates of clinical trial participation, comparing general and screened samples to enrolled sample. Odds ratios were adjusted for gender, geocoded median household income, cancer type, and stage. Results: Of the 84,977 patients with a cancer diagnosis, N = 2606 were screened for clinical trial participation and consented, and of those N = 1372 enrolled. The percent of Latinx (25.8% vs 24.0%; OR 0.9? CI 0.72-1.05) and African American/Black (10.9% vs 11.1%; OR 0.92 CI 0.75-1.11) clinical trial participation mirrored that of the general oncology population, respectively using Non-Hispanic Whites as reference. Asian/Pacific Islander had equal odds of clinical trial enrollment (OR 1.08 CI 0.92-1.27). The enrolled population was younger than the general oncology population. Conclusions: This study suggests that in an integrated healthcare system with equal access to care, the clinical trials population is well representative of its general oncology population.[Table: see text]

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Parental perspectives long term after neonatal clinical trial participation: a survey

Trials ◽

10.1186/s13063-020-04787-0 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Thomas Salaets ◽

Emilie Lavrysen ◽

Anne Smits ◽

Sophie Vanhaesebrouck ◽

Maissa Rayyan ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Trial Participation ◽

Drug Trials ◽

Clinical Trial Participation ◽

Parental Perspectives ◽

Positive Experiences ◽

Almost All

Abstract Background Although recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care. There is a lack of empirical data on the parental perspectives following participation of their neonate in a clinical trial, especially at long term. The objective of this study is to assess experiences and emotions of parents, long term after trial participation in an interventional drug trial. Methods Parents of former participants of five neonatal interventional drug trials were surveyed at long term (3–13 years ago) after participation. The survey assessed parental contentment with trial participation, perceived influence of the trial on care and health, emotional consequences of participation, and awareness of typical clinical trial characteristics on 6-point Likert scales. Results Complete responses were received from 123 parents (52% of involved families). Twenty percent of parents did not remember participation. Those who remembered participation reported high contentment with overall trial participation (median 5.00), but not with follow-up (median 3.00). Most parents did not perceive any influence of the trial on care (median 2.00) and health (median 2.43). Almost all parents reported satisfaction and pride (median 4.40), while a minority of parents reported anxiety and stress (median 1.44) or guilt (median 1.33) related to trial participation. A relevant minority was unaware of typical trial characteristics (median 4.20; 27% being unaware). Conclusions Overall, parents reported positive experiences and little emotional distress long term after participation. Future efforts to improve the practice of neonatal clinical trials should focus on ensuring effective communication about the concept and characteristics of a clinical trial during consent discussions and on the follow-up after the trial.

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Patient Income Level and Cancer Clinical Trial Participation

Journal of Clinical Oncology ◽

10.1200/jco.2012.45.4553 ◽

2013 ◽

Vol 31 (5) ◽

pp. 536-542 ◽

Cited By ~ 114

Author(s):

Joseph M. Unger ◽

Dawn L. Hershman ◽

Kathy S. Albain ◽

Carol M. Moinpour ◽

Judith A. Petersen ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Universal Access ◽

Participation Rate ◽

Treatment Decision ◽

Trial Participation ◽

Lower Income ◽

Clinical Trial Participation ◽

Clinical Trial Results ◽

The Impact

Purpose Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation. Patients and Methods We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. Results From 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ≥ 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P < .001). Conclusion Lower-income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels.

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Barriers to clinical trial accrual: Clinical trialists' perspectives.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e18156 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e18156-e18156

Author(s):

Edward S. Kim ◽

Dax Kurbegov ◽

Patricia A. Hurley ◽

David Michael Waterhouse

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Cost Benefit ◽

Trial Participation ◽

Clinical Trial Participation ◽

Eligibility Criteria ◽

Contract Research Organization ◽

The Public ◽

Community Forum ◽

Clinical Trial Accrual

e18156 Background: Oncology clinical trial participation rates remain at historic lows. There are many barriers that impede participation. Understanding those barriers, from the perspective of cancer clinical trialists, will help develop solutions to increase physician and site engagement, with the goal of improving accrual rates and advancing cancer treatment. Methods: Physician investigators and research staff from community-based and academic-based research sites were surveyed during ASCO’s Research Community Forum (RCF) Annual Meeting (N = 159) and through a pre-meeting survey (N = 124) in 2018. Findings and potential solutions were discussed during the meeting. Results: 84% of respondents (n = 84) reported that it took 6-8 months to open a trial and 86% (n = 81) reported that trials had unnecessary delays 70% of the time. The top 10 barriers to accrual identified were: insufficient staffing resources, restrictive eligibility criteria, physician buy-in, site access to trials, burdensome regulatory requirements, difficulty identifying patients, lack of suitable trials, sponsor and contract research organization requirements, patient barriers, and site cost-benefit. Respondents shared strategies to address these barriers. Conclusions: The current state of conducting clinical trials is not sustainable and hinders clinical trial participation. New strategies are needed to ensure patients and practices have access to trials, standardize and streamline processes, reduce inefficiencies, simplify trial activation, reduce regulatory burden, provide sufficient compensation to sites, engage the community and patients, educate the public, and increase collaborations. The ASCO RCF offers resources, available to the public, that offer practical strategies to overcome barriers to clinical trial accrual and has ongoing efforts to facilitate oncology practice participation in clinical trials.

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Transforming the site feasibility assessment process for oncology clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e14092 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e14092-e14092

Author(s):

Dax Kurbegov ◽

Patricia A. Hurley ◽

David Michael Waterhouse ◽

Grzegorz S. Nowakowski ◽

Edward S. Kim

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Task Force ◽

Assessment Process ◽

Trial Participation ◽

Clinical Trial Participation ◽

Contract Research Organization ◽

Feasibility Assessment ◽

Oncology Research ◽

Start Up

e14092 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and no-value steps that impact research site resources and clinical trial participation. This project sought stakeholder feedback on recommendations to transform industry sponsor and contract research organization (CRO) processes for evaluating sites for trials. Methods: An ASCO task force developed recommendations to improve the feasibility assessment process and standardize and centralize questions and forms. A survey was conducted with sites, industry trial sponsors, and CROs to obtain feedback and assess buy-in for the recommendations. Results: Respondents were from 28 oncology research sites (19 academic, 9 community-based), 8 sponsors, and 4 CROs. All stakeholders agreed that the current process is burdensome (93% sites, 90% sponsors, 100% CROs), standardization will improve the process (86% sites, 87% sponsors, 75% CROs). All agreed a centralized portal will reduce burdens (93% sites, 100% sponsors, 75% CROs) and expedite trial start-up (89% sites, 100% sponsors, 75% CROs). Site certification was a viable option for sites (86%) and CROs (75%), but less so for sponsors (57%). Most respondents preferred a two-tier model: 1) a short site questionnaire followed by a pre-study visit for new interactions, and 2) only a pre-study site visit or a teleconference if there is an existing relationship. The greatest benefits were time savings, expedited start-up, reduction in personnel resources, and cost savings. The greatest barriers to adoption were buy-in and alignment from sponsors/CROs and insufficient information about site or protocol. Top predictors of a site’s success on a trial were physician engagement, available patients, and site experience. Conclusions: Site feasibility assessments are important for all stakeholders to establish trial suitability. However, current methods impose tremendous burdens on site resources (reported by authors elsewhere). While this sample is limited, the proposed process and standardization changes show promise to reduce burdens and costs for all stakeholders and expedite patient enrollment onto clinical trials.

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Understanding Factors That Determine Clinical Trial Enrollment for African American Patients with Lymphoma

Blood ◽

10.1182/blood-2021-152433 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4965-4965

Author(s):

Gygeria Manuel ◽

Amy Ayers ◽

Jonathan Berman ◽

Shannon Blee ◽

Claire Sibold ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

African American ◽

African Americans ◽

Cell Lymphoma ◽

B Cell Lymphoma ◽

Trial Participation ◽

Clinical Trial Participation ◽

Large B Cell Lymphoma ◽

Emory University

Abstract Background: Although the incidence of non-Hodgkin lymphoma (NHL) is lower in minority populations, there is a difference in presentation, survivorship and participation in clinical trials (Becnel et al., 2017). African American patients with diffuse large B-cell lymphoma (DLBCL) present with more aggressive features including higher lactate dehydrogenase, increased frequency of B-symptoms, and higher rate of HIV co-infection, while also presenting at a younger age than other patients. (Tiu et al., 2020). Given the association of race with lymphoma presentation and outcomes, minority participation in clinical trials is of vital importance when developing novel therapies. There have been efforts to increase participation of African Americans in cancer clinical trials including patient navigation outreach which resulted in improvement of 9% to 16% of patients approached (Fouad et al., 2016). However, a recent study illustrated that for DLBCL, acute myeloid leukemia, and acute lymphoblastic leukemia, individuals of African descent represented 1.5%, 2.3%, and 6.7% of clinical trial participants, respectively (Gopishetty et al., 2020). We are conducting the current study to identify factors that influence decisions regarding clinical trial participation in African American patients with NHL. Methods: We are identifying African American patients with diffuse large B cell lymphoma and follicular lymphoma who enrolled in a therapeutic clinical trial at Emory University between 2010-2020. We will utilize the electronic medical record to identify patient characteristics such as distance from medical facility, insurance status, type of insurance, comorbidities, education status, type of diagnosis, and race of diagnosing physician. This data will compare African American patients who participated in clinical trials to those who did not participate as part of their initial treatment, specifically comparing baseline characteristics of interest between the groups. Furthermore, the data mention above will be compared between African American and white patients. We are also conducting interviews with a selected group of African American patients that have opted to participate in therapeutic clinical trials to gain a thorough understanding of the barriers and benefits they endured during their experience. The interview questions are based on prior knowledge of clinical trials, distance to facility, religious/ spiritual belief, trust of the physician, additional expenses, and time corresponded to treatment. Patients are asked to rate the importance each factor in their decision to participate and elaborate on points most specific to them. In addition, the interview allows for discussion of possible factors that challenged their participation in clinical trials which may allow for insight on low participation levels nationally. Furthermore, we are going to target patients who enrolled on clinical trials and will subsequently identify patients who did not participate in studies to identify differences in perception of treatment and clinical investigation. This project is partnered with Accounting for the High Enrollment of African Americans in Winship Cancer Institute's Clinical Trials, at Emory University. Conclusions:This study is currently enrolling patients and will answer key questions related to clinical trial participation in African American patients with lymphoma. We aim for the data collected from this study to assist in creating lymphoma clinical trials that better cater to the unique needs and considerations of African Americans. Disclosures Cohen: Genentech, Takeda, BMS/Celgene, BioInvent, LAM, Astra Zeneca, Novartis, Loxo/Lilly: Research Funding; Janssen, Adaptive, Aptitude Health, BeiGene, Cellectar, Adicet, Loxo/Lilly, AStra ZenecaKite/Gilead: Consultancy.

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A Pilot Study of a Culturally-Appropriate, Educational Intervention to Increase Participation in Cancer Clinical Trials Among African Americans and Latinos

10.21203/rs.3.rs-461056/v1 ◽

2021 ◽

Author(s):

Jennifer Cunningham-Erves ◽

Tilicia Mayo-Gamble ◽

Pamela C Hull ◽

Tao Lu ◽

Claudia Barajas ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

African Americans ◽

Educational Program ◽

Trial Participation ◽

Willingness To Participate ◽

Culturally Appropriate ◽

Clinical Trial Participation ◽

Medical Researchers ◽

Town Halls

Abstract Aim: Culturally-appropriate, educational programs are recommended to improve cancer clinical trial participation among African Americans and Latinos. This study investigated the effect of a culturally-appropriate, educational program on knowledge, trust in medical researchers, and intent for clinical trial participation among African Americans and Latinos in Middle Tennessee.Method: Trained community health educators delivered a 30-minute presentation with video testimonials to 198 participants in 13 town halls. A pre-post survey design was used to evaluate the intervention among 102 participants who completed both pre- and post-surveys one to two weeks after the session. Results: Paired-sample t-test showed significant increases in unadjusted mean scores for knowledge (p < .001), trust in medical researchers (p < .001), and willingness to participate in clinical trials (p = .003) after the town halls in the overall sample. After adjusting for gender and education, all three outcomes remained significant for the overall sample (knowledge: p < .001; trust in medical researchers: p < .001; willingness: p = .001) and for African Americans (knowledge: p < .001; trust in medical researchers: p = .007; willingness: p = .005). However, willingness to participate was no longer significant for Latinos (knowledge: p < .001; trust in medical researchers: p = .034; willingness: p = .084).Conclusions: The culturally-appropriate, educational program showed promising results for short-term, clinical trial outcomes. Further studies should examine efficacy to improve research participation outcomes.

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Clinical trial participation in America: The roles of eHealth engagement and patient–provider communication

Digital Health ◽

10.1177/20552076211067658 ◽

2021 ◽

Vol 7 ◽

pp. 205520762110676

Author(s):

Shaohai Jiang ◽

Y. Alicia Hong

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

The United States ◽

Equation Modeling ◽

Trial Participation ◽

Provider Communication ◽

Clinical Trial Participation ◽

Patient Centered ◽

Targeted Interventions ◽

Patient Provider Communication

Objective Public participation in a clinical trial is the foundation of clinical research and the cornerstone for the discovery of new treatment and improving health outcomes. This study aims to examine how eHealth engagement, patient–provider communication, and clinical trial knowledge are associated with clinical trial participation in the United States. Methods Data were drawn from the Health Information National Trends Survey Iteration 5 Cycle 4 conducted in 2020. The sample included 3865 American adults aged 18 years and above. Path analysis using structural equation modeling and hierarchical linear regression was performed to examine the effects of eHealth engagement and patient–provider communication on clinical trial participation. Results About 5% of American adults have ever participated in a clinical trial. Younger adults, males, minorities, and people with lower education, less clinical trial knowledge, and less eHealth engagement were less likely to participate. After controlling for demographic variables, we found that more eHealth engagement led to a better knowledge of clinical trials, which was strongly associated with participation. Further, patient-centered communication did not directly lead to clinical trial participation; instead, it positively moderated the relationship between clinical trial knowledge and participation. Conclusions The national survey data indicate that American participation in clinical trials remains low and a significant disparity exists. Within the context of the eHealth movement, it is critical to implement targeted interventions to improve clinical trial knowledge, address the digital divide, and enhance patient-centered communication.

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Stepwise examination of prostate clinical trials participation to reduce accrual barriers.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.5_suppl.157 ◽

2012 ◽

Vol 30 (5_suppl) ◽

pp. 157-157

Author(s):

Dare Olatoye ◽

Michael Anthony Carducci ◽

Norma Kanarek

Keyword(s):

Prostate Cancer ◽

Clinical Trial ◽

Clinical Trials ◽

Medical Oncology ◽

Local Therapy ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Trial Participation ◽

Therapeutic Trial ◽

Clinical Trial Participation

157 Background: Adequate and representative enrollment in therapeutic clinical trials is important to an NCI cancer center. Clinical trial participation is a string of 6 sequential patient and physician decisions beginning with an available therapeutic trial to enrollment in the trial. Opportunities for participation may be lost at any one of these steps. The objective of this study was to calculate transitional probabilities that measure patient, especially minority patient, accrual to clinical trials at the Sidney Kimmel Comprehensive Cancer Center and to describe the barriers for those dropping out at each step. Methods: Records for “first visit” medical oncology patients seen by three SKCCC physicians from January to April 2010 were abstracted. Prostate cancer case reports from the hospital cancer registry and a medical record review provided age, race, Hispanic ethnicity, place of residence, tumor characteristics, and prior treatment history. At each transition step, we calculated the proportion of patients who remained enrollable. Results: Overall, prostate cancer clinical trial participation was 17% (16/94). Minority accrual was similar to Caucasian accrual at 19% and 17% , respectively. Retention at each step of trial participation was highest for “discussed” (98%), “enrolled” (94%), “eligibility” for available trials (79%), and “consented” (71%). Two bottlenecks were qualitatively identified: “trial availability” (65%) and “patient interest” (51%). Forty-two percent of those for whom there was no trial available were older than 70 years and 33% were patients with rising PSA after local therapy and hormone-naïve. The “patient interest” step was shaped primarily by disinterest due to distance to SKCCC (83%). Conclusions: For prostate cancer patients, recruitment to medical oncology clinical trials is robust. Minority patients however are only 17% of all patients seen and half drop out when no trial is available and half of those remaining judged distance to be a problem (hence, no interest). This study approach has clarified which factors are likely to be barriers to participation and is likely useful to making adjustments that can reduce identified barriers by adding to trial portfolio as an example.

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