Cancer clinical trial accrual patterns among community cancer centers in the United States

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6041-6041
Author(s):  
J. A. Lee ◽  
M. A. Mathiason ◽  
C. A. Czeczok ◽  
J. K. Keller ◽  
R. S. Go
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Cancer Patients ◽  
The United States ◽  
Cooperative Groups ◽  
Medical Support ◽  
Cancer Centers ◽  
Number Of Patients ◽  
Clinical Trial Accrual ◽  
The U.S

6041 Background: Most cancer patients are diagnosed and treated in the community but clinical trial accrual rate is low. Published data on trial accrual from community-based cancer centers throughout the U.S. are limited. The Association of Community Cancer Centers (ACCC) is a national multidisciplinary education and advocacy organization that maintains a membership caring for over 60% of all patients with cancer in the U.S. In order to determine the clinical trial accrual patterns in the community across various geographic regions in the U.S., we performed a retrospective study utilizing the data from ACCC membership maintained at their web site. Methods: Data available from the most recent year (2003–2005) were obtained from 621 centers throughout the U.S., representing 49 states (no data for WY) and the DC. We investigated the number of patients (new and old) accrued into trials per year relative to the number of new analytical patients seen in the same year, a value we termed accrual ratio (AR). In addition, we studied the effects of geographic location, size of the cancer program, number of affiliations with National Cancer Institute sponsored cancer cooperative groups, and the number of medical/support/data management staffs on trial accrual. Results: A total of 670,215 new patients were seen across the ACCC membership with 43,743 patients accrued into trials for a median AR of 6.5% (range, 0.3–16.9). The top and bottom 5 accruing states were VT, MD, SD, LA, ID and KS, ND, VA, NH, AR, respectively. Regionally, the AR for Midwest, Middle Atlantic, West, South, Southwest, and New England were as follows: 7.4%, 7.0%, 6.2%, 6.0%, 5.7%, and 5.4% (p < 0.001). One hundred (16.1%) centers representing 11.8% of all new patients were not affiliated with any of the cooperative groups. This group had the lowest AR (3.1%). AR increased when centers were affiliated with more cooperative groups (p < 0.001) or cared for more new patients (p < 0.001). The number of medical, support, and data management staffs did not influence accrual. Conclusions: Overall, clinical trial accrual in the U.S. community cancer centers is low. Accrual patterns differed significantly among various geographic locations. Better access to trials is needed in order to improve participation of cancer patients. No significant financial relationships to disclose.

scholarly journals Health Care Access Measures and Palliative Care Use by Race/Ethnicity among Metastatic Gynecological Cancer Patients in the United States

2021 ◽  
Vol 18 (11) ◽  
pp. 6040
Author(s):  
Jessica Y. Islam ◽  
Veeral Saraiya ◽  
Rebecca A. Previs ◽  
Tomi Akinyemiju
Keyword(s):  
Palliative Care ◽  
Cancer Patients ◽  
Gynecological Cancer ◽  
The United States ◽  
Care Utilization ◽  
Treatment Facility ◽  
Facility Type ◽  
Race Ethnicity ◽  
Distance To Care ◽  
The U.S

Palliative care improves quality-of-life and extends survival, however, is underutilized among gynecological cancer patients in the United States (U.S.). Our objective was to evaluate associations between healthcare access (HCA) measures and palliative care utilization among U.S. gynecological cancer patients overall and by race/ethnicity. We used 2004–2016 data from the U.S. National Cancer Database and included patients with metastatic (stage III–IV at-diagnosis) ovarian, cervical, and uterine cancer (n = 176,899). Palliative care was defined as non-curative treatment and could include surgery, radiation, chemotherapy, and pain management, or any combination. HCA measures included insurance type, area-level socioeconomic measures, distance-to-care, and cancer treatment facility type. We evaluated associations of HCA measures with palliative care use overall and by race/ethnicity using multivariable logistic regression. Our population was mostly non-Hispanic White (72%), had ovarian cancer (72%), and 24% survived <6 months. Five percent of metastatic gynecological cancer patients utilized palliative care. Compared to those with private insurance, uninsured patients with ovarian (aOR: 1.80,95% CI: 1.53–2.12), and cervical (aOR: 1.45,95% CI: 1.26–1.67) cancer were more likely to use palliative care. Patients with ovarian (aOR: 0.58,95% CI: 0.48–0.70) or cervical cancer (aOR: 0.74,95% CI: 0.60–0.88) who reside >45 miles from their provider were less likely to utilize palliative care than those within <2 miles. Ovarian cancer patients treated at academic/research programs were less likely to utilize palliative care compared to those treated at community cancer programs (aOR: 0.70, 95%CI: 0.58–0.84). Associations between HCA measures and palliative care utilization were largely consistent across U.S. racial-ethnic groups. Insurance type, cancer treatment facility type, and distance-to-care may influence palliative care use among metastatic gynecological cancer patients in the U.S.

scholarly journals Barriers to accrual and enrollment in brain tumor trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2024-2024 ◽  
Author(s):  
Eudocia Quant Lee ◽  
Ugonma Nnenna Chukwueke ◽  
Shawn L. Hervey-Jumper ◽  
John Frederick De Groot ◽  
Jose Pablo Leone ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Response Assessment ◽  
Patient Advocacy ◽  
Cooperative Groups ◽  
Advocacy Groups ◽  
Oncology Patient ◽  
Clinical Trial Accrual ◽  
Multi Stakeholder ◽  
Patient Advocacy Groups ◽  
Major Impediment

2024 Background: A major impediment to improving neuro-oncology outcomes is poor clinical trial accrual. Methods: We convened a multi-stakeholder group including Society for Neuro-Oncology, Response Assessment in Neuro-Oncology, patient advocacy groups, clinical trial cooperative groups, and other partners to determine how we can improve trial accrual. Results: We describe selected factors contributing to poor trial accrual and possible solutions. Conclusions: We will implement strategies with the intent to double trial accrual over the next 5 years. [Table: see text]

Identification of Cancer Care and Protocol Characteristics Associated With Recruitment in Breast Cancer Clinical Trials

2008 ◽  
Vol 26 (27) ◽  
pp. 4458-4465 ◽  
Author(s):  
Julie Lemieux ◽  
Pamela J. Goodwin ◽  
Kathleen I. Pritchard ◽  
Karen A. Gelmon ◽  
Louise J. Bordeleau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Primary Objective ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Number Of Patients ◽  
Trial Protocols ◽  
Few Data

Purpose It is estimated that only 5% of patients with cancer participate in a clinical trial. Barriers to participation may relate to available protocols, physicians, and patients, but few data exist on barriers related to cancer care environments and protocol characteristics. Methods The primary objective was to identify characteristics of cancer care environments and clinical trial protocols associated with a low recruitment into breast cancer clinical trials. Secondary objectives were to determine yearly recruitment fraction onto clinical trials from 1997 to 2002 in Ontario, Canada, and to compare recruitment fraction among years. Questionnaires were sent to hospitals requesting characteristics of cancer care environments and to cooperative groups/pharmaceutical companies for information on protocols and the number of patients recruited per hospital/year. Poisson regression was used to estimate the recruitment fraction. Results Questionnaire completion rate varied between 69% and 100%. Recruitment fraction varied between 5.4% and 8.5% according to year. More than 30% of patients were diagnosed in hospitals with no available trials. In multivariate analysis, the following characteristics were associated with recruitment: use of placebo versus not (relative risk [RR] = 0.80; P = .05), nonmetastatic versus metastatic trial (RR = 2.80; P < .01), and for nonmetastatic trials, protocol allowing an interval of 12 weeks or longer versus less than 12 weeks (from diagnosis, surgery, or end of therapy) before enrollment (RR = 1.36; P < .01). Conclusion Allowable interval of 12 weeks or longer to randomly assign patients in clinical trials could help recruitment. In our study, absence of an available clinical trial represented the largest barrier to recruitment.

scholarly journals Clinical Trial Accrual Targeting Genomic Alterations After Next-Generation Sequencing at a Non-National Cancer Institute–Designated Cancer Program

2016 ◽  
Vol 12 (4) ◽  
pp. e396-e404 ◽  
Author(s):  
Kalyan C. Mantripragada ◽  
Adam J. Olszewski ◽  
Andrew Schumacher ◽  
Kimberly Perez ◽  
Ariel Birnbaum ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Next Generation Sequencing ◽  
National Cancer Institute ◽  
Next Generation ◽  
Genomic Alterations ◽  
Cancer Centers ◽  
Cancer Program ◽  
Clinical Trial Accrual ◽  
Generation Sequencing

Purpose: Successful clinical trial accrual targeting uncommon genomic alterations will require broad national participation from both National Cancer Institute (NCI)–designated comprehensive cancer centers and community cancer programs. This report describes the initial experience with clinical trial accrual after next-generation sequencing (NGS) from three affiliated non–NCI-designated cancer programs. Materials and Methods: Clinical trial participation was reviewed after enrollment of the first 200 patients undergoing comprehensive genomic profiling by NGS as part of an institutional intuitional review board–approved protocol at three affiliated hospitals in Rhode Island and was compared with published experience from NCI-designated cancer centers. Results: Patient characteristics included a median age of 64 years, a median of two lines of prior therapy, and a predominance of GI carcinomas (58%). One hundred sixty-four of 200 patients (82%) had adequate tumor for NGS, 95% had genomic alterations identified, and 100% had variants of unknown significance. Fifteen of 164 patients (9.2%) enrolled in genotype-directed clinical trials, and three patients (1.8%) received commercially available targeted agents off clinical trials. The reasons for nonreceipt of NGS-directed therapy were no locally available matching trial (48.6%), ineligibility (33.6%) because of comorbidities or interim clinical deterioration, physician's choice of a different therapy (6.8%), or stable disease (11%). Conclusion: This experience demonstrates that a program enrolling patients in specific targeted agent clinical trials after NGS can be implemented successfully outside of the NCI-designated cancer program network, with comparable accrual rates. This is important because targetable genes have rare mutation rates and clinical trial accrual after NGS is low.

Screening cancer patients for clinical trial eligibility: A randomized study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6529-6529
Author(s):  
J. Wright ◽  
T. Whelan ◽  
J. Julian ◽  
M. Simunovic ◽  
M. Levine
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Primary Outcome ◽  
Randomized Study ◽  
Secondary Analysis ◽  
Chi Square ◽  
Ongoing Research ◽  
Number Of Patients ◽  
The Difference

6529 Background: The overall proportion of cancer patients enrolled into clinical trials is undesirably low. Research suggests many aspects of the recruitment process can be improved. The present study was undertaken to evaluate the benefit of identifying potentially eligible (PE) clinical trial patients for physicians. Methods: Consenting physicians were randomized to 26 weeks of screening support or not, and were then crossed-over to the other strategy for a second 26-week time period. A computer program reviewed new patient consultations to identify PE clinical trial patients. Physicians receiving support were provided with written individualized details of patient eligibility for trials prior to their medical consultation. The primary outcome of interest was the difference, by physician, in the number of patients who were approached for consent to enter a clinical trial. Results: Thirty-six physicians participated in the 52-week study. 5051 consultations were screened in a blinded fashion, 2,376 when physicians had support and 2,675 when they did not. 939 of 2,376 (39.5%) consultations were identified as involving PE patients when physicians were receiving support, and 1,061 of 2,675 (39.7%) when without. The primary outcome of the study, by physician, did not demonstrate a statistically significant improvement, with 4.1 patients per physician without vs. 4.7 patients with screening support (p>0.05). Secondary analysis demonstrated that the overall proportion of patients approached with the clinical trial option increased from 149/2,675 (5.6%) to 169/2,376 (7.1%) with screening support (Chi-square, p=0.024) and that the number of patients that entered a clinical trial also increased from 60/2,675 (2.2%) to 83/2,376 (3.5%) (Chi-square, p=0.007). Conclusions: This study suggests that individualized patient screening for clinical trial eligibility may be useful to improve the numbers of patients approached to consider clinical trials. The number of new patients that entered clinical trials remained low, and ongoing research to facilitate improvements is required. No significant financial relationships to disclose.

Distribution and geographic accessibility of prostate cancer clinical trials in the United States.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 59-59 ◽  
Author(s):  
Matt D. Galsky ◽  
Asma Latif ◽  
Kristian D. Stensland ◽  
Erin L. Moshier ◽  
Russell McBride ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Geographic Distribution ◽  
The United States ◽  
First Line ◽  
Trial Site ◽  
Lorenz Curves ◽  
Number Of Patients

59 Background: An extremely small proportion of patients with cancer in the United States (US) enroll in clinical trials. While several barriers to trial accrual have been described, the geographic distribution and accessibility of clinical trial sites has not been comprehensively explored. Methods: ClinicalTrials.gov was queried to identify all active US clinical trials exploring first-line therapies for metastatic prostate cancer (PCa) on 9/16/2012. We evaluated the geographic distribution of trial sites and determined the relationship between the number of sites and the number of patients with advanced PCa per county and evaluated heterogeneity using Lorenz curves. We also estimated the minimum driving distance required to access a clinical trial site from each ZIP code in the continguous US; a distance >30 miles was defined as high travel burden consistent with prior studies. Results: We identified 958 sites associated with 42 PCa clinical trials (Table). The geographic distribution of clinical trial sites was very inhomogeneous with several states having only 1-2 trial sites. Among 3185 US counties, 2,669 (83.8%) had no clinical trials available for first-line treatment of metastatic PCa. Counties with larger populations of patients with advanced PCa had significantly higher numbers of clinical trial sites. For every 100 additional patients with advanced PCa per county, the number of available trial sites increased by 21.0% (95% CI: 16.5-25.7%). However, Lorenz curves indicated a high degree of inequality in trial accessibility (Gini index 0.71). Approximately 31% of the US population resided >30 miles from a PCa trial site. Conclusions: Clinical trials sites are poorly accessible, geographically, to a large subset of US PCa patients, a finding that likely contributes to dismal accrual. Innovative solutions are required to address geographic barriers to access. [Table: see text]

scholarly journals Retrospective Study of Incidence and Survival for Patients with Hematologic Malignancies Residing at the U.S./Mexico Border

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4782-4782
Author(s):  
Alfonso Enrique Bencomo ◽  
Andres J Rubio ◽  
Mayra Alejandra Gonzalez ◽  
Idaly Maria Olivas ◽  
Joshua Lara ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Myeloid Leukemia ◽  
El Paso ◽  
Hematologic Malignancies ◽  
The United States ◽  
The State ◽  
Blood Cancer ◽  
Hispanic Patients ◽  
Mexico Border ◽  
The U.S

Introduction: Hispanics represent the largest minority group in the United States (U.S.), with 57.5 million individuals (18% of the population). Most U.S. Hispanics are of Mexican origin (63.2%), followed by Puerto Rican (9.5%), Cuban (3.9%), Salvadoran (3.8%), and Dominican (3.3%), but distribution varies by state. The majority of Hispanics in the U.S. reside in the Southwest region, and >11 million live in the state of Texas. Cancer is the leading cause of death in the Hispanic population, accounting for 21% of deaths in people of all ages. Health disparities for Hispanic cancer patients have previously been linked to disproportionate poverty and other barriers to optimal healthcare, and in the case of acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), Hispanics were found to be diagnosed younger and to have worse overall survival (OS) than Non-Hispanic whites (NHWs) (ACS. Cancer Facts & Figures for Hispanics/Latinos 2018-2020). However, little is known about incidence and survival for Hispanic blood cancer patients residing at the U.S./Mexico border. To understand the impact of Hispanic ethnicity on outcomes for blood cancer patients diagnosed in this area, we examined OS in adult patients with hematologic malignancies throughout the state of Texas compared to Texas Health Service Region (HSR) 10, encompassing El Paso County. Methods: We retrospectively reviewed data available from the Texas Cancer Registry for hematologic malignancies diagnosed in the state of Texas between 1995 and 2016, focusing our analysis on chronic and acute leukemias (both myeloid and lymphoid), myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPNs). Survival for Hispanic and NHW groups was compared using the log-rank test, and Cox regression analyses adjusting for age and diagnosis. Differences in age at diagnosis were evaluated using t-tests and generalized linear models. Similar analyses compared Hispanic patients from HSR 10 versus Hispanic patients from the rest of Texas. Research was conducted according to a local Institutional Review Board-approved protocol in accordance with the Declaration of Helsinki. Results: Of the 69,941 cases of hematologic malignancies with available information throughout the state of Texas, 18.29% self-identified as Hispanic. Surprisingly, in unadjusted analyses, Hispanic patients had significantly better OS than NHWs diagnosed with AML (p<0.0001), MDS (p<0.0001), and chronic myeloid leukemia (CML, p<0.0001), with no significant differences in OS for patients with ALL, MPN, acute promyelocytic leukemia (APL), or chronic lymphocytic leukemia (CLL). However, Hispanic patients were diagnosed at a significantly younger age in all diseases analyzed (Table 1), possibly explaining the improved survival. After adjusting for age, ALL (HR 1.32, p<.0001), CLL (HR 1.11, p=0.002), and CML (HR 1.15, p=0.008) showed significantly worse outcomes for Hispanics, with better outcomes in MDS (HR 0.92, p=0.0004), and no significant differences for AML, APL or MPN. Running the same analyses for the entire El Paso population versus the rest of Texas, we found no significant interaction except for a suggestion of a greater ethnic disparity in CML patients from El Paso (p=0.06). We also compared Hispanic patients diagnosed in El Paso versus Hispanics from the rest of Texas. Hispanics in El Paso had a significant reduction in OS compared to Hispanics in other areas of Texas for patients with ALL (p=0.0164), AML (p<0.0001), and CML (p=0.0160), but not for patients with APL, CLL, MDS, or MPN. Again the negative effects become less marked after adjustment for age, as those diagnosed in El Paso tended to be 3 years older at diagnosis than elsewhere in Texas. In analyses adjusted for age and diagnosis, there was again a suggestion that differences between El Paso and the rest of Texas were greater in Hispanics than NHW (p=0.08). Conclusions: While Hispanic patients with AML, MDS, and CML had significantly better OS compared to NHWs in Texas as a whole, this could be explained by a significant reduction in the age of diagnosis for Hispanics. However, when comparing across Texas, El Paso Hispanics with ALL, AML, and CML have a worse prognosis than in the rest of the state. There appears to be evidence that disparities in outcome by ethnicity may be different in El Paso compared with the rest of Texas. Further study is required to identify factors responsible for the disparity in OS. Disclosures No relevant conflicts of interest to declare.

Poor access to clinical trials among community cancer patients requiring chemotherapy for recurrent or progressive disease: Limitations of current cancer cooperative groups

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6076-6076 ◽  
Author(s):  
L. A. Meyer ◽  
J. A. Lee ◽  
M. A. Mathiason ◽  
K. A. Frisby ◽  
K. C. Bruden ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Progressive Disease ◽  
Cancer Center ◽  
Cooperative Groups ◽  
Newly Diagnosed ◽  
Poor Access ◽  
Accrual Rate ◽  
Clinical Trial Accrual ◽  
A Prospective Study

6076 Background: Data on clinical trial accrual among cancer patients treated in the community are limited. In a prospective study at our community-based cancer center, we found that the accrual rate was only 4% for newly diagnosed patients and protocol limitations accounted for 68% of non-accrual (Go RS, et al. Cancer 2006). We would like to determine the availability of trials for adult cancer patients with recurrent or progressive disease treated in the community and the accrual rate. Methods: We retrospectively identified this specific group of patients who received chemotherapy at our institution between November 2004 and October 2005 and collected data on the number, types, and sources of trials that were available. Results: We identified a total of 140 patients. There was an equal number of females (52.9%) and males, with a median age of 66 years (range, 38–89) at the time of chemotherapy. Fifty trials were available, with about half for the following cancers: lung (14%), pancreatic (12%), renal (10%), head and neck (8%), prostate (6%), and breast (6%). No trials were available for bladder, colorectal, and gastroesophageal cancers. The proportions of phase I, II, and III trials were 4%, 62%, and 34%, respectively. The sources of trials were: ECOG (56%), Wisconsin Oncology Network (14%), Intergroup (12%), GOG (10%), RTOG (2%), CTSU (2%), our institution (2%), and pharmaceutical companies (2%). Only 69 (49.3%) patients had trials appropriate for their type and stage of cancers. Among those patients with available trials, 24 (34.8%) were eligible to participate and 6 were enrolled, for an overall accrual rate of 4.3%. There were no differences in age and sex among subgroups in terms of trial availability, eligibility, and accrual. Conclusions: At our institution, enrollment of cancer patients with recurrent or progressive disease in clinical trials is as low as for newly diagnosed patients. Over 80% of the patients were denied access to a trial because of protocol unavailability and ineligibility. Current cancer cooperative groups do not provide adequate trials for patients in the community. No significant financial relationships to disclose.

Funding of biomarker, imaging, quality-of-life (QOL), and cost-effectiveness analysis (CEA) studies by NCI.

2012 ◽  
Vol 30 (30_suppl) ◽  
pp. 104-104
Author(s):  
Ray A. Petryshyn ◽  
Geoffrey David Seidel ◽  
Sheila Ann Prindiville
Keyword(s):  
Clinical Trial ◽  
Treatment Effectiveness ◽  
Phase Iii ◽  
Standards Of Care ◽  
Cooperative Groups ◽  
Specimen Collection ◽  
Randomized Phase Ii ◽  
Funding Program ◽  
Integrated Studies ◽  
Clinical Trial Accrual

104 Background: NCI’s purpose for the Biomarker, Imaging, and QOL Studies Funding Program (BIQSFP) is to ensure that the most important, scientifically meritorious biomarker, imaging, QOL, and/or CEA studies can be initiated in a timely manner in association with NCI clinical trials. BIQSFP studies are embedded in selected large, randomized phase II treatment trial concepts with a control arm and an integral study(ies), along with integral and/or integrated studies associated with phase III treatment trials, cancer prevention trials, and primary symptom management trials. Methods: BIQSFP provides opportunities to enhance clinical outcomes by validating targets, reducing morbidity, predicting treatment effectiveness, identifying populations that may better benefit from treatment, improving clinical trial accrual and retention, and modifying standards of care. BIQSFP applications are accepted from NCI Cooperative Groups and Community Clinical Oncology Programs. Integral components must be performed in order for the trial to proceed. Integral studies have the highest funding priority. Integrated components are clearly identified as part of the clinical trial from the beginning, are intended to identify or validate (in the patient population of interest) assays/tests/QOL tools that are planned for use in future trials, are performed in real time, and include complete plans for specimen collection, laboratory measurements, and statistical analysis. Integrated studies in general should not be exploratory but rather should be designed to test a hypothesis, not simply to generate hypotheses. Results: Since 2009, 36 BIQSFP funding applications have been reviewed with most evaluations via NCI’s Scientific Steering Committees (http://ccct.cancer.gov/). Twenty studies have been approved for BIQSFP funding. Conclusions: BIQSFP information presented in the poster includes scope of activity, process for application and evaluation, and funded projects (http://biqsfp.cancer.gov/). Funded by NCI Contract No. HHSN261200800001E.

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