Clinical Trial Enrollment Rates Research Articles

EPID-35. CLINICAL TRIAL ENROLLMENT RATE AMONG ADOLESCENT AND YOUNG ADULTS WITH CENTRAL NERVOUS SYSTEM TUMOR AT DANA-FARBER CANCER INSTITUTE (DFCI)

Abstract BACKGROUND Adolescents and young adults (AYAs; 15–39 yrs.) are a population recognized as facing significant challenges in cancer care and research, characterized by historically poor participation in clinical trials. The clinical trial enrollment rate among AYAs with CNS tumor is unclear. We report the findings from our study evaluating the clinical trial enrollment rate of AYAs with CNS glioma at DFCI, comparing the rates between its affiliated adult and children’s hospitals. METHODS We performed a retrospective cohort study of patients with primary CNS glioma treated at our center between 2008–18. Eligible patients were identified using institutional databases at Boston Children’s Hospital and Brigham and Women’s Hospital. Manual chart review and data abstraction from the electronic medical record were performed to obtain key variables. Clinical trial enrollment rates were reported, followed by univariate and multivariate logistic regression models to identify factors affecting clinical trial enrollment. RESULTS In the adult setting, a total of 608 AYA patients with glioma were identified to meet our inclusion criteria and presented with a median age of 32 years (range:15–39). 92 out of 608 (15%) patients enrolled in a clinical trial during their treatment course. Within this cohort, tumor type was significantly associated with clinical trial enrollment, with higher-grade tumors associated with better enrollment rates (p< 0.001). On the contrary in the pediatric setting, a total of 52 AYA patients were identified from the children’s hospital, with a median age of 17.2 years (range:15–25.4) of whom, 19 out of 52 (36.5%) patients were enrolled on a clinical trial. CONCLUSION Clinical trial enrollment rate remains poor among AYAs with CNS tumors, with tumor type/histology grade associated with enrollment rate. Higher enrollment rates were seen among early AYAs treated at the children’s hospital.

MASTER KEY Project: Powering Clinical Development for Rare Cancers Through a Platform Trial.

For rare cancers, challenges in establishing standard therapies are greater than those for major cancers, and effective methods are needed. MASTER KEY Project is a multicenter study based in Japan, with two main parts: prospective registry study and multiple clinical trials. Advanced rare cancers, cancers of unknown primary origin, and those with rare tissue subtypes of common cancers are targeted. The registry study accumulates highly reliable consecutive data that can be used for future drug development. The multiple trials are conducted simultaneously, targeting either a specific biomarker or a rare tumor type of interest. The first interim data set from the registry part presented here shows the prevalence of genetic abnormalities, response rates, survival rates, and clinical trial enrollment rates. From May 2017 to April 2019, 560 patients (mean age = 53) were enrolled in the project. Frequent cancer types included soft tissue sarcomas, neuroendocrine tumors, and central nervous system tumors. Among the 528 patients with assessable data, 69% (364/528) had next‐generation sequencing tests, with 48% (176/364) harboring an “actionable” alteration. Seventy‐one (13%) patients have been enrolled in one of the clinical trials, with an accrual rate of 3.94 patients/month. A descriptive analysis of biomarker‐directed or non‐biomarker‐directed treatment survival was performed. This project is expected to accelerate development of treatments for rare cancers and show that comprehensive platform trials are an advantageous strategy.

Readability of Cancer Clinical Trials Websites.

Clinical trials are critically important for the development of new cancer treatments. According to recent estimates, however, clinical trial enrollment is only about 8%. Lack of patient understanding or awareness of clinical trials is one reason for the low rate of participation. The purpose of this observational study was to evaluate the readability of cancer clinical trial websites designed to educate the general public and patients about clinical trials. Nearly 90% of Americans use Google to search for health-related information. We conducted a Google Chrome Incognito search in 2018 using the keywords “cancer clinical trial” and “cancer clinical trials.” Content of the 100 cancer clinical trial websites was analyzed using an online readability panel consisting of Flesch-Kincaid Grade Level, Flesch Reading Ease, Gunning-Fog Index, Coleman-Liau Index, and Simple Measure of Gobbledygook scales. Reading level difficulty was assessed and compared between commercial versus non-commercial URL extensions. Content readability was found to be “difficult” (10.7 grade level). No significant difference in readability, overall, and between commercial and non-commercial URL extensions was found using 4/5 measures of readability; 90.9% of commercial versus 49.4% of non-commercial websites were written at a >10th grade (P = .013) using Gunning-Fog Index. Written cancer clinical trials content on the Internet is written at a reading level beyond the literacy capabilities of the average American reader. Improving readability to accommodate readers with basic literacy skills will provide an opportunity for greater comprehension that could potentially result in higher rates of clinical trial enrollment.

Comparison of Health Outcomes in Adolescent and Young Adults (AYA) Oncology Patients Treated at a Pediatric Versus Adult Institute

BACKGROUND Overall survival for adolescent and young adult (AYA) cancer population, ages 15 to 39 years, demonstrated minimal improvement during the last several decades. Potential factors influencing inferior outcomes within this group include the complex biology of AYA cancers, lower rates of clinical trial enrollment, the significant toxicities caused by therapies, and unmet psychosocial needs. AYA patients can often be treated in either pediatric or adult institutions. The type of institution where they receive treatment is influenced by age, type of cancer, and distance from a pediatric oncology center. There are concerns that differences in care between pediatric and adult treatment settings are influencing the slow progress in improving outcomes. Acute care utilization might reflect the burden of toxicities and access to care, which might vary based on treatment setting. There is limited research suggesting that AYAs treated at pediatric institutes are more likely to be enrolled in clinical trials. The AYA population also has challenging psychosocial needs and it is unknown if there is a difference in how those needs are addressed in different treatment settings. The objective of this study was to examine whether there are differences in clinical trial enrollment, acute care utilization, and psychosocial support between AYA oncology patients treated at a pediatric versus an adult facility. Our hypothesis was that AYAs treated at a pediatric facility will have increased enrollment in clinical trials, less acute care utilization, and more psychosocial referrals compared to AYAs treated at an adult facility. METHODS We conducted a retrospective cohort study of patients ages of 15 to 39 years who were diagnosed with a hematologic malignancy (acute lymphoblastic leukemia (ALL), acute myelocytic leukemia (AML), Hodgkin lymphoma (HL) and Non-Hodgkin Lymphoma (NHL)) and were cared for at a pediatric or adult facility during the years 2013-2017. The primary health outcomes examined were acute care utilization and psychosocial resources utilized, based on a patient's exposure time (defined as one year from diagnosis or 1 month after completion of therapy, whichever came first). Data were analyzed using SAS 9.4. To compare the health outcomes between patients treated at the two facilities, the Chi-square test or Fisher's exact test was used for categorical variables. For continuous variables, due to the skewness of the data, a log transformation was applied to the length of stay (LOS) variable, and then the Student's t-test was used. The Mann-Whitney test was used for the other continuous variables. This study was approved by the Children's Hospital of Wisconsin Institutional Review Board. RESULTS A total of 196 patients were treated as either newly diagnosed or relapse/progressive patients who received care at the pediatric or adult treatment facilities. Leukemia patients treated at a pediatric facility were more likely to be enrolled on a clinical trial than patients treated at an adult facility (84% vs 22%, p<0.0001). There was no statistically significant difference in enrollment in clinical trials for lymphoma patients at both treatment facilities (4% vs 8%, p=0.68) as shown in Table 1. There was no significant difference in acute care utilization for ED visits or inpatient hospitalizations for all diagnoses for the pediatric and adult facilities. Both ALL and HL patients had more ICU admissions per month at the pediatric facility compared to the adult facility (ALL: mean 0.25 vs 0.05, p=0.021; HL: mean 0.03 vs 0, p=0.0027). ALL and HL patients had longer hospitalization LOS at the adult facility (ALL p=0.020, HL p=0.014) There were more referrals for psychology, social work or case management and palliative care in the pediatric versus adult facility (p<0.0001, p=0.011, p<0.0001, respectively). CONCLUSION For AYA patients treated at a pediatric institute, leukemia patients have higher rates of clinical trial enrollment and all patients receive more psychosocial support compared to AYA patients treated at an adult institute. There was no difference in acute care utilization for ED visits or hospitalizations between patients treated at a pediatric or an adult facility. Patients with ALL and HL have more ICU admissions but overall shorter hospital LOS at the pediatric institution. Further work to determine the impact of these findings on the long-term outcomes and survival of AYA patients is needed. Disclosures Panepinto: NIH: Research Funding.

Role of Racial, Demographic and Socioeconomic Disparities in Treatment Patterns and Outcomes in AML

Role of Racial, Demographic and Socioeconomic Disparities in Treatment Patterns and Outcomes in AML

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.

Assessment of enrollment characteristics for Children’s Oncology Group (COG) upfront therapeutic clinical trials 2004-2015.

6564 Background: Improvements in pediatric cancer survival are attributed to cooperative clinical trials. Under representation of specific demographic groups has been described in adult and pediatric cancer and poses a threat to the generalizability of trial results. A comprehensive evaluation of data provided by the Children’s Oncology Group (COG) of upfront trial enrollment for US patients 0 to 29 years old between 2004 and 2015 was performed to assess for disparities in participation. Methods: Estimates of cancer cases were calculated using the Surveillance, Epidemiology, and End Results registry and the US Census and compared to observed COG cases. Percent enrollment and Standardized Ratios of enrollment were calculated across various demographic, disease, and socioeconomic groups. The COG website was utilized to quantify available upfront trials during the study period and assess age eligibility criteria. Results: 21.3% of estimated US cancer patients age 0 to 19 years enrolled on COG trials. Younger patients were consistently more represented across disease types and race/ethnicities. Patients with hematologic malignancies were more represented compared to solid and central nervous system (CNS) tumors. Conclusions: COG clinical trial enrollment rates are declining, which may be due to challenges in pediatric drug development, difficulty designing feasible trials for highly curable diseases, and issues in ensuring trial availability for the heterogeneous group of solid and CNS tumors. Though racial/ethnic groups and county-level socioeconomic factors were proportionally represented, under representation of the adolescent/young adult (AYA) population and younger patients with solid and CNS tumors remain significant concerns. Targeted enrollment efforts should focus on the identified subgroups and further research should evaluate AYA enrollment across all available trials to provide continued treatment advances for all patients.

Nonmetropolitan residence and other factors affecting clinical trial enrollment for adolescents and young adults with cancer in a US population-based study.

Cancer survival rates in adolescents and young adults (AYAs) have shown slow improvements in comparison with other age groups, and this may be due to lower participation in clinical trials. Little evidence has been provided regarding how nonmetropolitan residence may influence clinical trial enrollment for AYAs with cancer. This study sought to determine whether AYAs from nonmetropolitan areas have lower rates of clinical trial enrollment than their urban counterparts and to examine factors associated with enrollment variation. Data from the National Cancer Institute's 2006 and 2013 Surveillance, Epidemiology, and End Results Patterns of Care AYA cohorts were analyzed. Patients with acute lymphoblastic leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma, and sarcoma were included (n=3155). Urban influence codes were used to measure the rurality of the county of residence at diagnosis, which was categorized as large metropolitan, small metropolitan, or nonmetropolitan. Logistic regression compared trial participants and nonparticipants while adjusting for patient and provider factors. Compared with AYAs from large metropolitan counties, AYAs from small metropolitan (odds ratio [OR], 2.04; 95% confidence interval [CI], 1.57-2.64) or nonmetropolitan counties (OR, 1.86; 95% CI, 1.23-2.81) experienced greater trial enrollment. AYAs treated at a hospital with a residency program (OR, 2.27; 95% CI, 1.63-3.16) or by a pediatric oncologist (OR, 4.02; 95% CI, 3.03-5.32) were associated with greater enrollment. There was a significant interaction between rurality and hospital size, which had the greatest impact on nonmetropolitan enrollment. Clinical trial enrollment was higher among AYAs from nonmetropolitan counties than those from metropolitan counties, predominantly when they were treated at large hospitals.

Adolescent angst: enrollment on clinical trials.

Survival among adolescents and young adults (AYAs) ages 15 to 39 with cancer has not improved to the same extent as that of pediatric and older adult cancer patients, which is thought to relate, in part, to the lower participation of AYAs in clinical trials. Because significant efforts have been made to improve clinical trial enrollment for AYAs, we (1) present contemporary clinical trial enrollment rates by cancer type, sociodemographic characteristics, and treatment setting and (2) discuss provider-, patient-, and system-level barriers to clinical trial participation. Contemporary studies examining clinical trial enrollment among AYAs have continued to find low overall participation relative to pediatric populations, with most studies observing no significant improvements in enrollment over time. In addition to age and cancer type, enrollment varies by treatment setting, health insurance, and race/ethnicity. Access to available clinical trials may be increased by appropriate referral of AYAs to pediatric and adult specialty cancer centers with studies relevant to the AYA population because most AYAs are treated in the community setting. Even with similar access to trials, however, AYAs may be less likely to participate, and therefore, future efforts should focus on better understanding and addressing barriers to enrollment as well as improving education and outreach regarding clinical trials.

A randomized, triple negative breast cancer enrolling trial to confirm molecular profiling improves survival (ARTEMIS).

TPS590 Background: Following neoadjuvant chemotherapy (NACT), patients (pts) with triple negative breast cancer (TNBC) achieving pathologic complete response/residual cancer burden-0 (pCR/RCB-0) or minimal residual disease (RCB-I) have an improved relapse free survival when compared to pts with more extensive residual disease (RCB-II/III) (Symmans et al, JCO 2017). Pts with chemo-resistant TNBC have a poor prognosis as there are currently no FDA-approved targeted agents available for TNBC. We previously reported the ability of a novel gene expression signature (GES) to predict sensitivity to NACT (Hatzis et al, JAMA 2011). Here we seek to prospectively validate the use of this GES in combination with imaging to predict response to NACT and establish the clinical impact of selecting pts predicted to have non-responsive disease (NRD) for enrollment in clinical trials of targeted therapy. Methods: All pts will undergo a biopsy of the primary tumor for molecular characterization (MC) and will be randomized 2:1 to know their MC results (intervention arm) or not (control arm). A maximum of 360 pts will be enrolled and randomized using a group sequential design with one-sided O’Brien-Fleming boundaries, with two equally spaced binding interim tests for futility and superiority and one final test, having an overall Type I error of 0.05 and power of 0.80 to detect an improvement in pCR/RCB-I from 50% to 64%. Secondary endpoints include rates of clinical trial enrollment, disease free survival and integrated biomarker analyses. All pts will receive 4 cycles of anthracycline-based NACT with imaging done every 2 cycles to assess response. After completion or progression on anthracycline-based NACT, pts predicted to have NRD based on MC/imaging (intervention arm) or imaging alone (control arm) will be offered enrollment on a clinical trial. Pts are eligible if they have stage I-III TNBC with a primary tumor that is ≥1.5cm. Pts with contraindications to anthracyclines and/or taxanes are excluded. Enrollment began in November 2015. 105 pts have been enrolled to date with 71 and 34 pts randomized to the intervention and control arms, respectively. Clinical trial information: NCT02276443.

No improvement in clinical trial enrollment for adolescents and young adults with cancer at a children's hospital.

We have previously published data from 2001 to 2006 showing that adolescent and young adult (AYA) oncology patients have significantly lower therapeutic clinical trial enrollment rates than younger patients. Our objective was to determine if the enrollment of AYA patients on therapeutic studies at the same institution has improved in recent years with the greater focus on this population locally and nationally. We retrospectively analyzed cancer registry data at the Children's Hospital of Pittsburgh (CHP) for all new oncologic diagnoses between January 2010 and December 2014. These data included age, gender, diagnosis, race and whether the patient was enrolled on an open treatment study. Univariate analyses were carried out to compare demographic data between AYA patients (aged 15-22) who enrolled on study and those who did not. Eight hundred sixty-five new oncology patients were seen at CHP during this time, 23% of whom were 15 years or older; 33% of all patients were treated on a clinical trial, including 34% of younger patients and 24% of older patients (P = 0.0017). The differences between these rates and those from prior years in both age groups (38% and 27%, respectively) were not statistically significant (P = 0.15, 0.53). The most common reason for the low enrollment rates was again the lack of an open therapeutic trial. Despite initiatives at CHP and on the national level to enroll more AYA patients on clinical trials, our most recent data show no improvement. This is a potentially remediable factor that needs to continue to be prioritized nationally.

Abstract OT3-2-05: Improving outcomes in triple-negative breast cancer (TNBC) using molecular triaging and diagnostic imaging to guide neoadjuvant therapy

Abstract BACKGROUND: Known disparities exist in patients with TNBC treated using neoadjuvant chemotherapy (NACT) with 30-50% having excellent response to treatment (pCR/RCB-I) and good survival prognosis, while 50-70% demonstrate marked residual disease (RCB-II-III) with significantly worse prognosis. Lack of response early into NACT also indicates a low chance (5%) of achieving pCR. Thus, it is important to develop diagnostic platforms predictive of pCR, in order to direct patients with responsive disease toward standard NACT and non-responsive disease toward experimental therapies within clinical trials. TRIAL DESIGN This study will determine the impact of predicting response to NACT using both molecular and imaging diagnostics and will determine if offering a clinical trial of selected targeted therapy will impact outcomes (as measured by pCR and RCB) in predicted non-responsive disease. An algorithm that incorporates pre-defined genomic signatures will determine predicted sensitivity to chemotherapy (JAMA, 2011; 305:1873-81). All patients will undergo biopsy of the primary tumor for molecular analyses, but will then be randomized 2:1 to know these results (Arm A) versus not (Arm B). All patients will begin anthracycline-based NACT with diagnostic imaging to assess response after 4 cycles. Patients who fit molecular/imaging criteria for non-responsive disease will be offered a clinical trial based upon molecular profiling (Arm A) or based upon physician/patient choice (Arm B). Patients who fit criteria for responsive disease in either arm will continue with taxane based NACT. ELIGIBILITY CRITERIA INCLUSION: Candidate for biopsy of the primary tumor site; tumor size > 1.5 cm diameter; TNBC by standard pathologic assays; >18 years of age; LVEF > 50%; adequate organ and bone marrow function EXCLUSION: Stage IV disease; history of invasive cancer within 5 years; excisional biopsy of the primary tumor; biopsy site changes that limit response assessment; medically unfit for chemotherapy; prior anthracycline; >grade II neuropathy; Zubrod performance status of >2; history of serious cardiac event PRIMARY AIM Primary Aim: to prospectively determine the impact of implementation of a research platform that includes molecular (genomic) testing from a primary tumor biopsy to predict response, and diagnostic imaging to assess response to standard NACT in patients with localized invasive TNBC. Secondary Aims: compare rates of clinical trial enrollment between study arms, compare DFS, integrated "prospective-retrospective" biomarker analysis, correlative science studies to identify therapeutic targets for resistant disease STATISTICAL METHODS AND TARGET ACCRUAL Success will be defined as an improvement in the rate of excellent pathologic response (pCR/RCB-I) from 50%-->64% using the triaging platform. A maximum of 360 patients will be randomized 2:1 to the experimental arm vs. the control arm using a group sequential design with one-sided O’Brien-Fleming boundaries, with up to two equally spaced binding interim tests for both futility and superiority and one final test, having an overall Type I error .05 and power .80 to detect a response rate improvement from a null rate of .50 to a target value of .642. Citation Format: Stacy Moulder-Thompson, Wei Yang, Naoto T Ueno, Joe Ensor, Vicente Valero, Ricardo Alvarez, Jennifer Litton, Rashmi Murthy, Nuhad Ibrahim, Banu Arun, Beth Mittendorf, Kelly Hunt, Funda Meric-Bernstam, Helen Piwnica-Worms, Rosalind Candelaria, Debu Tripathy, Fraser Symmans. Improving outcomes in triple-negative breast cancer (TNBC) using molecular triaging and diagnostic imaging to guide neoadjuvant therapy [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr OT3-2-05.

Influencing referral of adolescents and young adults with cancer to sites with higher rates of trial enrollment.

Adolescents and young adults (AYAs) have lower rates of clinical trial enrollment than younger or older patients with cancer. Multiple approaches to change policy and practice need to be used to improve this statistic. This article examines the option of increasing referral to 3 types of centers that are known to have relatively higher rates of enrollment of AYAs: pediatric cancer centers, AYA oncology programs, and National Cancer Institute-designated cancer centers. There are reasonable challenges to changing referral patterns, and more research, as well as education of those diagnosing AYAs, is required.

Factors and Outcomes of Decision Making for Cancer Clinical Trial Participation

To describe factors and outcomes related to the decision-making process regarding participation in a cancer clinical trial. Cross-sectional, descriptive. Urban, academic, National Cancer Institute-designated comprehensive cancer center in the mid-Atlantic United States. 197 patients with advanced gastrointestinal cancer. Mailed survey using one investigator-developed instrument, eight instruments used in published research, and a medical record review. disease context, sociodemographics, hope, quality of life, trust in healthcare system, trust in health professional, preference for research decision control, understanding risks, and information. decision to accept or decline research participation and satisfaction with this decision. All of the factors within the Research Decision Making Model together predicted cancer clinical trial participation and satisfaction with this decision. The most frequently preferred decision-making style for research participation was shared (collaborative) (83%). Multiple factors affect decision making for cancer clinical trial participation and satisfaction with this decision. Shared decision making previously was an unrecognized factor and requires further investigation. Enhancing the process of research decision making may facilitate an increase in cancer clinical trial enrollment rates. Oncology nurses have unique opportunities as educators and researchers to support shared decision making by those who prefer this method for deciding whether to accept or decline cancer clinical trial participation.

Patient navigation for American Indians undergoing cancer treatment

A study was undertaken to assess patient navigation utilization and its impact on treatment interruptions and clinical trial enrollment among American Indian cancer patients. Between February 2004 and September 2009, 332 American Indian cancer patients received patient navigation services throughout cancer treatment. The patient navigation program provided culturally competent navigators to assist patients with navigating cancer therapy, obtaining medications, insurance issues, communicating with medical providers, and travel and lodging logistics. Data on utilization and trial enrollment were prospectively collected. Data for a historical control group of 70 American Indian patients who did not receive patient navigation services were used to compare treatment interruptions among those undergoing patient navigation during curative radiation therapy (subgroup of 123 patients). The median number of contacts with a navigator was 12 (range, 1-119). The median time spent with the navigator at first contact was 40 minutes (range, 10-250 minutes), and it was 15 minutes for subsequent contacts. Patients treated with radiation therapy with curative intent who underwent patient navigation had fewer days of treatment interruption (mean, 1.7 days; 95% confidence interval [CI], 1.1-2.2 days) than historical controls who did not receive patient navigation services (mean, 4.9 days; 95% CI, 2.9-6.9 days). Of the 332 patients, 72 (22%; 95% CI, 17%-26%) were enrolled on a clinical treatment trial or cancer control protocol. Patient navigation was associated with fewer treatment interruptions and relatively high rates of clinical trial enrollment among American Indian cancer patients compared with national reports.

Different Rates of Clinical Trial Enrollment Between Adolescents and Young Adults Aged 15 to 22 Years Old and Children Under 15 Years Old With Cancer at a Children's Hospital

Over the last 30 years significant strides have been made in cure rates for children with cancer, but these improvements have not been seen in adolescents and young adults. The reasons for this lack of progress are multifactorial, but it is clear greater cure rates are correlated with controlled clinical trials. Our objective was to see if pediatric patients over the age of 15 had a lower rate of clinical trial enrollment, and if so, why. We retrospectively analyzed the clinical data on all patients with new oncology diagnoses at Children's Hospital of Pittsburgh (CHP) diagnosed over a 5-year period from July 2001 to June 2006. Six hundred and forty new oncology patients were seen at CHP over this time, 501 under 15 years old and 139 patients aged 15 to 22. Thirty-six percent of all patients were treated on a clinical trial, including 38% of the younger patients and 27% of the older patients (P=0.03). Fifty-seven percent in the older group were not enrolled on a clinical trial because one was not available versus 41% in the younger group (P=0.04). There were no significant differences between the age groups when other reasons were analyzed. A significantly lower proportion of adolescents and young adults patients (aged 15 to 22) were placed on a treatment trial than younger patients. The lack of an open clinical trial was the main reason for this deficit. Interventions to address this discrepancy need to be instituted on a national level.