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Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.

ABSTRACT: PURPOSE:The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual. METHODS:EP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the median were considered high-accruing sites. Analyses were performed to identify site characteristics associated with higher accrual onto EP trials. RESULTS:Twenty-seven of the 30 NCCCP sites participated. The median number of EP trials open per site over the course of July 2010-June 2011 was 19. Median EP accrual per site was 14 patients in 1 year. Approximately half of the EP trials were Cooperative Group; most were phase II. Except for having a higher number of EP trials open (P = .04), high-accruing sites (n = 14) did not differ significantly from low-accruing sites (n = 13) in terms of any single site characteristic. High-accruing sites did have shorter institutional review board (IRB) turnaround time by 20 days, and were almost three times as likely to be a lead Community Clinical Oncology Program site (small sample size may have prevented statistical significance). Most sites had at least basic EP trial infrastructure. CONCLUSION:Community cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.

SUBMITTER: Zaren HA

PROVIDER: S-EPMC3595451 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.

Zaren Howard A HA Nair Suresh S Go Ronald S RS Enos Rebecca A RA Lanier Keith S KS Thompson Michael A MA Zhao Jinxiu J Fleming Deborah L DL Leighton John C JC Gribbin Thomas E TE Bryant Donna M DM Carrigan Angela A Corpening Jennifer C JC Csapo Kimberly A KA Dimond Eileen P EP Ellison Christie C Gonzalez Maria M MM Harr Jodi L JL Wilkinson Kathy K Denicoff Andrea M AM

Journal of oncology practice 20130301 2

<h4>Purpose</h4>The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual.<h4>Methods</h4>EP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the medi ...[more]

PMID: 23814525

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Project description:BackgroundThe National Cancer Institute Community Cancer Centers Program (NCCCP) pilot was designed to improve quality of cancer care and reduce disparities at community hospitals. The NCCCP's primary intervention was the implementation of the Commission on Cancer Rapid Quality Reporting System (RQRS). The RQRS is a hospital-based data collection and evaluation system allowing near real-time assessment of selected breast and colon cancer quality of care measures. Building on previous NCCCP analyses, this study examined whether improvements in quality cancer care within NCCCP hospitals early in the program were sustained and whether improvements were notable for minority or underserved populations.MethodsWe compared changes in concordance with three breast and two colon cancer quality measures approved by the National Quality Forum for patients diagnosed at NCCCP hospitals from 2006 to 2007 (pre-RQRS), 2008 to 2010 (early-RQRS), and 2011 to 2013 (later-RQRS). Data were obtained from NCCCP sites participating in the Commission on Cancer Rapid Quality Reporting System. Logistic regression analyses were performed to identify predictors of concordance with breast and colon cancer quality measures.ResultsThe sample included 13,893 breast and 5,546 colon cancer patients. After RQRS initiation, all five quality measures improved significantly and improvements were sustained through 2013. Quality of care measures showed sustained improvements for both breast and colon cancer patients and for vulnerable patient subgroups including black, uninsured, and Medicaid-covered patients.ConclusionsQuality improvements in NCCCP hospitals were sustained throughout the duration of the program, both overall and among minority and underserved patients. Because many individuals receive cancer treatment at community hospitals, facilitating high-quality care in these environments must be a priority.Implications for practiceQuality improvement programs often improve practice, but the methods are not maintained over time. The implementation of a real-time quality reporting system and a network focused on improving quality of care sustained quality improvement at select community cancer centers. The NCCCP pilot increased numbers of patients receiving guideline-concordant care for breast and colon cancer in community settings, and initial improvements noted in earlier years of RQRS were sustained into later years, both overall and among minority and underserved patients. National initiatives that improve care for diverse patient groups are important for reducing and eliminating barriers to care.

Project description:ImportanceEstablishment of an optimal cancer surveillance program is important to reduce cancer-related morbidity and mortality in individuals with Li-Fraumeni syndrome, a rare, highly penetrant cancer predisposition syndrome.ObjectiveTo determine the feasibility and efficacy of a comprehensive cancer screening regimen in Li-Fraumeni syndrome, using multiple radiologic techniques, including rapid whole-body magnetic resonance imaging (MRI) and laboratory measurements.Design, setting, and participantsBaseline evaluation of a prospective cancer screening study was conducted from June 1, 2012, to July 30, 2016, at the National Cancer Institute, National Institutes of Health (an academic research facility). Participants included 116 individuals with Li-Fraumeni syndrome with a germline TP53 pathogenic variant who were aged 3 years or older at the time of baseline screening and had not received active cancer therapy at least 6 months prior to screening.Main outcomes and measuresDetection of prevalent cancer with multimodal screening techniques and the need for additional evaluation.ResultsOf the 116 study participants, 77 (66.4%) were female; median age was 37.6 years (range, 3-68 years). Baseline cancer screening led to the diagnosis of cancer in 8 (6.9%) individuals (2 lung adenocarcinomas, 1 osteosarcoma, 1 sarcoma, 1 astrocytoma, 1 low-grade glioma, and 2 preinvasive breast cancers [ductal carcinoma in situ]); all but 1 required only resection for definitive treatment. A total of 40 (34.5%) participants required additional studies to further investigate abnormalities identified on screening, with 32 having incidental, benign, or normal findings, resulting in a false-positive rate of 29.6%. Non-MRI techniques, including baseline blood tests, abdominal ultrasonography in children, mammography, and colonoscopy, did not lead to a diagnosis of prevalent cancer in our cohort.Conclusions and relevanceThis study describes the establishment and feasibility of an intensive cancer surveillance protocol for individuals with Li-Fraumeni syndrome. Prevalent cancers were detected at an early stage with baseline whole-body, brain, and breast MRI. Prospective screening of the participants is under way.

Project description:IntroductionIn 2005, the National Cancer Institute funded the Community Networks Program (CNP), which aimed to reduce cancer health disparities in minority racial/ethnic and underserved groups through community-based participatory research, education, and training. The purpose of this study was to describe the CNP model and their tobacco-related work in community-based research, education, and training using a tobacco disparities research framework.MethodsWe conducted a comprehensive review of the CNP tobacco-related activities including publications, published abstracts, research activities, trainee pilot studies, policy-related activities, educational outreach, and reports produced from 2005-2009. Two authors categorized the tobacco-related activities and publications within the framework.ResultsAlthough there was no mandate to address tobacco, the CNPs produced 103 tobacco-related peer-reviewed publications, which reflects the largest proportion (12%) of all CNP cancer-related publications. Selected publications and research activities were most numerous under the framework areas "Psychosocial Research," "Surveillance," "Epidemiology," and "Treatment of Nicotine Addiction." Thirteen CNPs participated in tobacco control policymaking in mainstream efforts that affected their local community and populations, and 24 CNPs conducted 1147 tobacco-related educational outreach activities. CNP activities that aimed to build research and infrastructure capacity included nine tobacco-related pilot projects representing 16% of all CNP cancer-related pilot projects, and 17 publications acknowledging leveraged partnerships with other organizations, a strategy encouraged by the CNP.ConclusionsThe CNP is a promising academic-community model for working to eliminate tobacco-related health disparities. Future efforts may address scientific gaps, consider collaboration across groups, assess the extent of operationalizing community-based participatory research, and improve common tracking measures.

Dataset Information

Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.

Publications

Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.

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