Organizational and physician factors associated with patient enrollment in cancer clinical trials.

BACKGROUND: Our purpose was to identify physicians' individual characteristics, attitudes, and organizational contextual factors associated with higher enrollment of patients in cancer clinical trials among physician participants in the National Cancer Institute's Community Clinical Oncology Program (CCOP). We hypothesized that physicians' individual characteristics, such as age, medical specialty, tenure, CCOP organizational factors (i.e. policies and procedures to encourage enrollment), and attitudes toward participating in CCOP would directly determine enrollment. We also hypothesized that physicians' characteristics and CCOP organizational factors would influence physicians' attitudes toward participating in CCOP, which in turn would predict enrollment. METHODS: We evaluated enrollment in National Cancer Institute-sponsored cancer clinical trials in 2011 among 481 physician participants using Structural Equation Modeling. The data sources include CCOP Annual Progress Reports, two surveys of CCOP administrators and physician participants, and the American Medical Association Masterfile. RESULTS: Physicians with more positive attitudes toward participating in CCOP enrolled more patients than physicians with less positive attitudes. In addition, physicians who practiced in CCOPs that had more supportive policies and practices in place to encourage enrollment (i.e. offered trainings, provided support to screen and enroll patients, gave incentives to enroll patients, instituted minimum accrual expectations) also significantly enrolled more patients. Physician status as CCOP Principal Investigator had a positive direct effect on enrollment, while physician age and non-oncology medical specialty had negative direct effects on enrollment. Neither physicians' characteristics nor CCOP organizational factors indirectly influenced enrollment through an effect on physician attitudes. CONCLUSION: We examined whether individual physicians' characteristics and attitudes, as well as CCOP organizational factors, influenced patient enrollment in cancer clinical trials among CCOP physicians. Physician attitudes and CCOP organizational factors had positive direct effects, but not indirect effects, on physician enrollment of patients. Our results could be used to develop physician-directed strategies aimed at increasing involvement in clinical research. For example, administrators may want to ensure physicians have access to support staff to help screen and enroll patients or institute minimum accrual expectations. Our results also highlight the importance of recruiting physicians for volunteer clinical research programs whose attitudes and values align with programmatic goals. Given that physician involvement is a key determinant of patient enrollment in clinical trials, these interventions could expand the overall number of patients involved in cancer research. These strategies will be increasingly important as the CCOP network continues to evolve.

Defining the Role of the Advanced Practice Provider Within the National Cancer Institute Community Oncology Research Program.

PURPOSE: Oncology advanced practice providers (APPs), including nurse practitioners, clinical nurse specialists, physician assistants, and clinical pharmacists, contribute significantly to quality cancer care. Understanding the research-related roles of APPs in the National Cancer Institute's (NCI) Community Oncology Research Program (NCORP) could lead to enhanced protocol development, trial conduct, and accrual. METHODS: The 2022 NCORP Landscape Assessment Survey asked two questions about the utilization and roles of APPs in the NCORP. RESULTS: A total of 271 practice groups completed the 2022 survey, with a response rate of 90%. Of the 259 nonpediatric exclusive practice groups analyzed in this study, 92% used APPs for clinical care activities and 73% used APPs for research activities. APPs most often provided clinical care for patients enrolled in trials (97%), followed by assistance with coordination (65%), presenting/explaining clinical trials (59%), screening patients (49%), ordering investigational drugs (37%), and consenting participants (24%). Some groups reported APPs as an enrolling investigator (18%) and/or participating in institutional oversight/selection of trials (15%). Only 5% of NCORP sites reported APPs as a site primary investigator for trials, and very few (3%) reported APPs participating in protocol development. CONCLUSION: Practice groups report involving APPs in clinical research within the NCORP network; however, opportunities for growth exists. As team-based care has enhanced clinical practice in oncology, this same approach can be used to enhance successful research. Suggested strategies include supporting APP research-related time, recognition, and education. The findings of this survey and subsequent recommendations may be applied to all adult oncology practices that participate in clinical research.

Oncologists' perceived confidence and attitudes toward managing pre-existing chronic comorbidities during patients' active cancer treatment.

PURPOSE: To examine practicing oncologists' perceived confidence and attitudes toward management of pre-existing chronic conditions(PECC) during active cancer treatment(ACT). METHODS: In December 2018, oncologists in the National Cancer Institute's Community Oncology Research Program (NCORP) were invited to complete a was pilot-tested, IRB-approved online survey about their perceived confidence in managing PECC. Pearson chi-square test was used to identify oncologists' differences in perceived confidence to manage PECC and attitudes toward co-management of patients' PECC with non-oncologic care providers. Perceived confidence and attitudes were analyzed as a function of medical specialty while controlling demographic and medical practice variables. RESULTS: A total of 391 oncologists responded to the survey, 45.8% stated medical oncology as their primary specialty, 15.1% hematology oncology, 15.1% radiation oncology, 6.9% surgical oncology, and 17.1% other specialties such as gynecology oncology. Overall, 68.3% agreed (agree/strongly agree) that they were confident to manage PECC in the context of standard of care. However, only 46.6% and 19.7% remained confident when managing PECC previously managed by a primary care physician (PCP) and by a non-oncology subspecialist, respectively. Most oncologists (58.3%) agreed that patients' overall care was well coordinated, and 63.7% agreed that patients had optimal cancer and non-cancer care when PECC was co-managed with a non-oncology care provider. CONCLUSION: Most oncologists felt confident to manage all PECC during patients' ACT, but their perceived confidence decreased for PECC previously managed by PCPs or by non-oncology subspecialists. Additionally, they had positive attitudes toward co-management of PECC with non-oncologic care providers. These results indicate opportunities for greater collaboration between oncologists and non-oncology care providers to ensure comprehensive and coordinated care for cancer patients with PECC.

A method for analyzing the business case for provider participation in the National Cancer Institute's Community Clinical Oncology Program and similar federally funded, provider-based research networks.

BACKGROUND: The Community Clinical Oncology Program (CCOP) plays an essential role in the efforts of the National Cancer Institute (NCI) to increase enrollment in clinical trials. Currently, there is little practical guidance in the literature to assist provider organizations in analyzing the return on investment (ROI), or business case, for establishing and operating a provider-based research network (PBRN) such as the CCOP. In this article, the authors present a conceptual model of the business case for PBRN participation, a spreadsheet-based tool and advice for evaluating the business case for provider participation in a CCOP organization. METHODS: A comparative, case-study approach was used to identify key components of the business case for hospitals attempting to support a CCOP research infrastructure. Semistructured interviews were conducted with providers and administrators. Key themes were identified and used to develop the financial analysis tool. RESULTS: Key components of the business case included CCOP start-up costs, direct revenue from the NCI CCOP grant, direct expenses required to maintain the CCOP research infrastructure, and incidental benefits, most notably downstream revenues from CCOP patients. The authors recognized the value of incidental benefits as an important contributor to the business case for CCOP participation; however, currently, this component is not calculated. CONCLUSIONS: The current results indicated that providing a method for documenting the business case for CCOP or other PBRN involvement will contribute to the long-term sustainability and expansion of these programs by improving providers' understanding of the financial implications of participation.

National Cancer Institute: Restructuring to Support the Clinical Trials of the Future.

OBJECTIVES: To describe the evolution and structure of the National Cancer Institute clinical trials programs, their notable accomplishments, nurses' roles in these accomplishments, and the essential role of nursing today and in the future. DATA SOURCES: Manuscripts, government publications, websites, and professional communications. CONCLUSION: Change is inevitable and a constant factor in the world of advancing science and clinical research. Nurses' contribution to research and evidence-based practice will continue to grow and is vital as the scientific landscape evolves. IMPLICATIONS FOR NURSING PRACTICE: As the understanding of cancer biology increases and clinical trials evolve, nurses will need to remain key team members and leaders in National Cancer Institute Community Oncology Research Program and National Cancer Trials Network trials and their associated infrastructure.

The National Cancer Institute and Department of Veterans Affairs Interagency Group to Accelerate Trials Enrollment (NAVIGATE): A federal collaboration to improve cancer care.

Cancer clinical trials represent an important option for patients with a diagnosis of cancer and the clinician-investigators involved in their care who seek options for their disease. For all who are impacted by cancer, these studies offer opportunities for greater learning. Conducting these important studies involves several challenges, including recruiting eligible participants. To address barriers that arise over the course of these activities, the Department of Veterans Affairs (VA) and National Cancer Institute (NCI) have partnered to increase Veteran participation in oncology clinical trials. This initiative, the NCI And VA Interagency Group to Accelerate Trials Enrollment, or NAVIGATE, is focused on addressing recruitment across the VA healthcare system and finding systematic solutions related to activating, recruiting for and conducting oncology clinical trials at VA Medical Centers. Additional goals include (1) establishing a sustainable network that can serve as a model for other VA sites interested in doing cancer clinical trials, (2) recruitment of minority patients, and (3) developing best practices and policies that can be deployed across the VA healthcare system. In this manuscript, we describe the scope, organization, activities, and future directions of NAVIGATE while also highlighting key needs for successfully conducting cancer clinical trials within the VA system. This partnership between 2 large federal agencies with a shared commitment to improving cancer care may provide lessons to others who are also dedicated to helping those affected by the disease.

Feasibility of a Centralized Clinical Trials Coverage Analysis: A Joint Initiative of the American Society of Clinical Oncology and the National Cancer Institute.

PURPOSE: Clinical trial billing compliance is a challenge that is faced by overburdened clinical trials sites. The requirements place institutions and research sites at increased potential for financial risk. To reduce their risk, sites develop a coverage analysis (CA) before opening each trial. For multisite trials, this translates into system-wide redundancies, inconsistencies, trial delays, and potential costs to sites and patients. These factors exacerbate low accrual rates to cancer clinical trials. ASCO and the National Cancer Institute (NCI) collaborated to address this problem. METHODS: An ASCO Research Community Forum working group proposed the concept of providing centrally developed CAs to research sites at protocol startup. The group collaborated with NCI and billing compliance experts to hold a symposium for key stakeholders to share knowledge, build skills, provide tools to conduct centralized CAs, and strategize about the next steps. RESULTS: Forty-eight attendees, who represented a range of stakeholders, participated in the symposium. As a result of this initiative, NCI directed the Cancer Trials Support Unit to convene a working group with NCI's National Clinical Trials Network (NCTN) and Community Oncology Research Program (NCORP) to develop tools and processes for generating CAs for their trials. A CA template with core elements was developed and is being adapted in a pilot project across NCTN Group and NCORP Research Bases. CONCLUSION: Centralized CAs for multisite trials-using standardized tools and templates-are feasible. They have the potential to reduce risk for patients and sites, forecast budget needs, and help decrease trial startup times that impede patient access and accrual to clinical trials.

A Randomized Controlled Study Comparing the National Cancer Institute's Original and Revised Consent Form Templates.

Since 1998, the National Cancer Institute (NCI) has mandated that researchers use its consent form template in developing consent forms for their NCI-funded clinical trials. The template was substantially revised in 2013 to aid in the development of simpler, more concise consent forms. The NCI conducted a randomized controlled trial with cancer survivors (N = 153) to assess the revised template's effect on individuals' knowledge, satisfaction, clarity, and likelihood of joining a trial in the future. We found that the revised template resulted in equally high knowledge and satisfaction scores as the original template, but with fewer words and pages. The likelihood that an individual would participate in a trial diminished after he or she reviewed either the original or revised consent form, yet having knowledge about trials before reviewing the consent forms resulted in increased satisfaction. To ensure an informed decision-making process, we recommend using the revised NCI consent form template along with using educational interventions aimed at increasing the understanding potential participants have of a trial before they receive a consent form.

Assessing Clinical Trial-Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool.

PURPOSE: Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial-associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. METHODS: Community-based research programs were recruited to collect and enter clinical trial-associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. RESULTS: Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. CONCLUSION: The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings.

Clinical Trial Assessment of Infrastructure Matrix Tool to Improve the Quality of Research Conduct in the Community.

PURPOSE: Several publications have described minimum standards and exemplary attributes for clinical trial sites to improve research quality. The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) developed the clinical trial Best Practice Matrix tool to facilitate research program improvements through annual self-assessments and benchmarking. The tool identified nine attributes, each with three progressive levels, to score clinical trial infrastructural elements from less to more exemplary. The NCCCP sites correlated tool use with research program improvements, and the NCI pursued a formative evaluation to refine the interpretability and measurability of the tool. METHODS: From 2011 to 2013, 21 NCCCP sites self-assessed their programs with the tool annually. During 2013 to 2014, NCI collaborators conducted a five-step formative evaluation of the matrix tool. RESULTS: Sites reported significant increases in level-three scores across the original nine attributes combined (P<.001). Two specific attributes exhibited significant change: clinical trial portfolio diversity and management (P=.0228) and clinical trial communication (P=.0281). The formative evaluation led to revisions, including renaming the Best Practice Matrix as the Clinical Trial Assessment of Infrastructure Matrix (CT AIM), expanding infrastructural attributes from nine to 11, clarifying metrics, and developing a new scoring tool. CONCLUSION: Broad community input, cognitive interviews, and pilot testing improved the usability and functionality of the tool. Research programs are encouraged to use the CT AIM to assess and improve site infrastructure. Experience within the NCCCP suggests that the CT AIM is useful for improving quality, benchmarking research performance, reporting progress, and communicating program needs with institutional leaders. The tool model may also be useful in disciplines beyond oncology.

Measuring clinical trial-associated workload in a community clinical oncology program.

PURPOSE: The ability to quantify clinical trial-associated workload can have a significant impact on the efficiency and success of a research organization. However, methods to effectively estimate the number of research staff needed for clinical trial recruitment, maintenance, compliance, and follow-up are lacking. To address this need, the Wichita Community Clinical Oncology Program (WCCOP) developed and implemented an acuity-based workload assessment tool to facilitate assessment and balancing of workload among its research nursing staff. METHODS: An acuity-based measurement tool was developed, assigning acuity scores for individual clinical trials using six trial-related determinants. Using trial acuity scores and numbers of patients per trial, acuity scores for individual research nursing staff were then calculated and compared on a monthly basis. RESULTS: During the 11 years that data were collected, acuity scores increased from 65% to 181%. However, during this same period, WCCOP was able to decrease individual research nurse staff full-time equivalent (FTE) acuity scores and number of patients per FTE. These trends reflect the use of the acuity-based measurement tool to determine actual workload and use of the acuity data to direct hiring decisions. CONCLUSION: Clinical trial workload has been successfully measured and used to guide staffing by one community clinical oncology program. Further research is needed regarding its applicability to other research programs.

Achieving high cancer control trial enrollment in the community setting: an analysis of the Community Clinical Oncology Program.

Determining the factors that lead to successful enrollment of patients in cancer control clinical trials is essential as cancer patients are often burdened with side effects such as pain, nausea, and fatigue. One promising intervention for increasing enrollment in cancer control trials is the National Cancer Institute's Community Clinical Oncology Program (CCOP). In this article, we examined CCOP staffing, policies, and procedures associated with enrollment in control trials. Data were obtained from three sources: the online CCOP, MB-CCOP, and Research Base Management System, CCOP Annual Progress Reports, and a survey of CCOP Administrators conducted in 2011. We analyzed cancer control trial accrual in 2011 among 46 CCOPs using multivariate regression. Three factors were significant predictors of accrual. First, having a team of staff dedicated to enrolling patients in control and prevention trials, compared to having no dedicated staff, was associated on average with an additional 30 patients enrolled in control trials (p<0.05). Second, CCOPs that recognized physicians for enrolling a large number of patients compared to CCOPs that did not recognize high enrolling physicians enrolled on average an additional 25 patients in control trials (p<0.05). Lastly, the number of cancer control trials available was also associated with enrollment (ß=5.50, p<0.00). Our results indicate that CCOPs looking to increase enrollment in control trials should consider dedicating a team of staff to enroll patients in these types of trials. In addition, CCOPs or other volunteer research systems looking to increase physician participation should consider recognizing high enrolling physicians.

The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.

INTRODUCTION: Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions. METHODS: The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature. RESULTS: Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations. CONCLUSIONS: A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided.

Engaging referring physicians in the clinical trial process.

By building relationships with referring physicians and educating them about the clinical trial process, oncologists can help increase trial accrual among patients with cancer.

Organizational designs for achieving high treatment trial enrollment: a fuzzy-set analysis of the community clinical oncology program.

PURPOSE: To examine the organizational design features that were consistently associated in 2010 with high levels of patient enrollment onto National Cancer Institute (NCI) cancer treatment trials among the oncology practices and hospitals participating in the NCI Community Clinical Oncology Program (CCOP). METHODS: Fuzzy-set qualitative comparative analysis was used to identify the recipes (ie, combinations of organizational design features) that CCOPs used to achieve high levels of patient enrollment onto NCI treatment trials in 2010. Four organizational design features were examined: number of open treatment trials with at least one patient enrolled, number of newly diagnosed patients with cancer, number of CCOP-affiliated physicians, and number of CCOP-affiliated hospitals or practices where patient enrollment could occur. Data were obtained from NCI data systems and CCOP grant progress reports. RESULTS: Two recipes were consistently associated with high levels of patient enrollment onto NCI treatment trials in 2010: having many open treatment trials and many new patients with cancer, and having many open treatment trials and many affiliated hospitals or practices. Together, these recipes accounted for nearly two thirds of CCOP membership in the high-performance set in 2010. CONCLUSION: No single organizational design feature, by itself, was consistently associated with high levels of patient enrollment onto NCI treatment trials in 2010. Having a large menu of active treatment trials may be necessary to achieve high-patient enrollment performance, but this is not sufficient unless combined with either large patient volume or many participating sites.

Oncology clinical trials nursing: developing competencies for the novice.

Oncology clinical trials are important in the improvement of outcomes for people with or at risk for cancer. Because of the complexity of oncology clinical trials and the needs of patients with cancer, nurses play a crucial and unique role in the trial setting. However, great variability exists in how the role of the nurse on a research team is defined and implemented. An Oncology Nursing Society project team set out to identify the core competencies required of a novice oncology clinical trials nurse (CTN) across diverse settings. This article describes the process used to develop core competencies for the novice CTN, presents the final core competencies, and offers examples of how those competencies might be used in practice.

Kansas office-based nurses' evaluation of patient tobacco cessation activities.

In this study, we examined the tobacco cessation efforts of nurses working in primary care settings. A 43-item questionnaire was mailed to 1,036 office-based nurses located throughout Kansas. With a response rate of 50.1%, 415 questionnaires were available for analysis. Although 89% of respondents encountered patients who smoked on a daily or weekly basis, only 51% reported documenting their patients' tobacco use, and 38% assessed patients' readiness to quit. Two thirds (66%) of nurses believed that tobacco management was part of their role but only 35% provided cessation advice, 23% recommended nicotine replacement therapy, and 14% provided coping techniques. Nurses cited barriers such as perceiving patients as disinterested or unmotivated to quit (65%) and having little time (55%), skills (32%), or knowledge (25%). Most (91%) agreed that they needed additional tobacco control education. Nurses who were advanced registered nurse practitioners or clinical nurse specialists were more likely to feel confident about their smoking cessation counseling skills compared to nurses with less education (66.7 vs. 31.2%, p =.010). Office-based nurses identified specific barriers that could be addressed through professional education about tobacco management.