Improving clinical research and cancer care delivery in community settings: evaluating the NCI community cancer centers program

Clauser, Steven B.; Johnson, Maureen; O’Brien, Donna M.; Beveridge, Joy; Fennell, Mary L.; Kaluzny, Arnold D.

doi:10.1186/1748-5908-4-63

Cited by 47 publications

(32 citation statements)

References 16 publications

(14 reference statements)

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“…Several NCI programs are designed to support research networks facilitating clinical trials access and cutting edge cancer care delivery among medically underserved populations, including the Cancer Disparities Research Partnership (CDRP) Program, the Community Networks Program (CNP), the Community Clinical Oncology Program (CCOP), the Minority-Based CCOP (MB-CCOP) and the Community Cancer Centers Program (NCCCP). 2, 23, 35–37 This study lends empirical support to the long anecdotally observed effectiveness of these programs. 5, 38 …”

Section: Discussionsupporting

confidence: 57%

A surveillance system for monitoring, public reporting, and improving minority access to cancer clinical trials

Carpenter

Tyree

et al. 2012

Clinical Trials

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Background The Institute of Medicine (IOM) has recommended that each person with cancer should have access to clinical trials, which have been associated with improving care quality and disparities. With no effective enrollment monitoring system, patterns of trial enrollment remain unclear. Purpose We developed a population-based, statewide system designed to facilitate monitoring of cancer trial enrollment and targeting of future interventions to improve it. Methods Person-level cancer incidence data from the North Carolina Central Cancer Registry (NCCCR), person-level treatment trial accrual data from the National Cancer Institute (NCI), and county-level Area Resource Files (ARF) measures for 12 years, 1996–2007, were studied. Deidentified person-level data necessitated county-level analysis. Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for each race, gender, year, and county combination. Multivariable analysis examined factors associated with trial accrual. Sensitivity analyses examined spurious fluctuations and temporal discordance of incidence and enrollment. Results The NCI treatment trial enrollment rate was 2.39% for whites and 2.20% for minorities from 1996 to 2007, and 2.88% and 2.47%, respectively, from 2005 to 2007. Numerous counties had no minority enrollment. The 2005–2007 enrollment rates for white and minority females was 4.04% and 3.59%, respectively, and for white and minority males was 1.74% and 1.36%, respectively. Counties with a medical school or NCI Community Clinical Oncology Program (CCOP)-affiliated practice had higher trial enrollment. Limitations We examined NCI trial accrual only – industry-sponsored and investigator-initiated trials were excluded; however, studies comprise the majority of all clinical trial participants. Delays in data availability may hinder the immediacy of population-based analyses. Conclusions Model stability and consistency suggest that this system is effective for population-based enrollment surveillance. For North Carolina, it suggests a worsening disparity in minority trial enrollment, though our analyses elucidate targets for intervention. Regional enrollment variation suggests the importance of access to clinical research networks and infrastructure. Substantial gender differences merit further examination.

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Section: Discussionsupporting

confidence: 57%

A surveillance system for monitoring, public reporting, and improving minority access to cancer clinical trials

Carpenter

Tyree

et al. 2012

Clinical Trials

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“…There are a few notable exceptions. For example, studies have found institutional theory useful for explaining how an organization’s external environment influences the integration of evidence into practice [23] and which intervention components are most likely to be sustained [24]. TCE has been used to explain how organizational networks form [25] and why organizations engaged in pay-for-performance may “game” the system, inflating performance scores to maximize payment [26].…”

Section: Discussionmentioning

confidence: 99%

Organizational theory for dissemination and implementation research

et al. 2017

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BackgroundEven under optimal internal organizational conditions, implementation can be undermined by changes in organizations’ external environments, such as fluctuations in funding, adjustments in contracting practices, new technology, new legislation, changes in clinical practice guidelines and recommendations, or other environmental shifts. Internal organizational conditions are increasingly reflected in implementation frameworks, but nuanced explanations of how organizations’ external environments influence implementation success are lacking in implementation research. Organizational theories offer implementation researchers a host of existing, highly relevant, and heretofore largely untapped explanations of the complex interaction between organizations and their environment. In this paper, we demonstrate the utility of organizational theories for implementation research.DiscussionWe applied four well-known organizational theories (institutional theory, transaction cost economics, contingency theories, and resource dependency theory) to published descriptions of efforts to implement SafeCare, an evidence-based practice for preventing child abuse and neglect. Transaction cost economics theory explained how frequent, uncertain processes for contracting for SafeCare may have generated inefficiencies and thus compromised implementation among private child welfare organizations. Institutional theory explained how child welfare systems may have been motivated to implement SafeCare because doing so aligned with expectations of key stakeholders within child welfare systems’ professional communities. Contingency theories explained how efforts such as interagency collaborative teams promoted SafeCare implementation by facilitating adaptation to child welfare agencies’ internal and external contexts. Resource dependency theory (RDT) explained how interagency relationships, supported by contracts, memoranda of understanding, and negotiations, facilitated SafeCare implementation by balancing autonomy and dependence on funding agencies and SafeCare developers.SummaryIn addition to the retrospective application of organizational theories demonstrated above, we advocate for the proactive use of organizational theories to design implementation research. For example, implementation strategies should be selected to minimize transaction costs, promote and maintain congruence between organizations’ dynamic internal and external contexts over time, and simultaneously attend to organizations’ financial needs while preserving their autonomy. We describe implications of applying organizational theory in implementation research for implementation strategies, the evaluation of implementation efforts, measurement, research design, theory, and practice. We also offer guidance to implementation researchers for applying organizational theory.

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“…With the goal of improving access to trials and diversity of enrollees, the National Cancer Institute (NCI) developed two cancer-focused practice-based research networks (PBRN) – Community Clinical Oncology Program (CCOP) in the early 1980s, and the National Community Cancer Centers Program (NCCCP) in the 2000s [1, 3, 4]. NCCCP aimed to improve the quality of cancer care delivered in community settings [1, 5] and the CCOP program engaged community physicians in NCI clinical trials [1, 6].…”

Section: Introductionmentioning

confidence: 99%

Enrollment and Racial Disparities in Cancer Treatment Clinical Trials in North Carolina

Zullig¹,

Fortune-Britt

Rao³

et al. 2016

North Carolina Medical Journal

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Background Clinical trials provide access to innovative, quality cancer treatment. Simultaneously, broad access helps ensure trial inclusion of heterogeneous patient populations, which improves generalizability of findings and development of interventions that are effective for diverse populations. We provide updated data describing enrollment into cancer treatment trials in North Carolina. Methods For 1996 to 2009, person-level data regarding cancer clinical trial enrollment and cancer incidence were obtained from the North Carolina Central Cancer Registry and the National Cancer Institute (NCI). Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for race, gender, and year for each county, Area Health Education Center (AHEC) region, and the state overall. Enrollment rates for common cancers are presented. Results From 1996 to 2009, North Carolina NCI treatment trial enrollment rate was 2.4% and 2.2% for whites and minorities, respectively. From 2007 to 2009, rates were 3.8% for white females, 3.5% for minority females, 1.3% for white men, and 1.0% for minority men, with greater enrollment among more urban populations (2.4%) than the most rural populations (1.5%). Limitations This study is limited to NCI-sponsored treatment trials in North Carolina. Policies governing collection of original data necessitate a delay in data availability. Conclusions Effort is needed to ensure trial access and enrollment among all North Carolina populations. Specifically, we identified racial and gender disparities, particularly for certain cancers (e.g., breast). Programs in North Carolina and across the nation can use the methods we employ to assess their success in broadening clinical trials enrollment for diverse populations.

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Improving clinical research and cancer care delivery in community settings: evaluating the NCI community cancer centers program

Cited by 47 publications

References 16 publications

A surveillance system for monitoring, public reporting, and improving minority access to cancer clinical trials

A surveillance system for monitoring, public reporting, and improving minority access to cancer clinical trials

Organizational theory for dissemination and implementation research

Enrollment and Racial Disparities in Cancer Treatment Clinical Trials in North Carolina

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