Applying the Strategic Planning Process to a Large Research Consortium: The Example of the National Cancer Institute Cohort Consortium.

Strategic planning is conducted by many organizations to systematically evaluate and assess their current state, establish or update their mission and/or goals, and identify strategies and activities to achieve the goals. The National Cancer Institute (NCI) Cohort Consortium is a collaborative network of 62 prospective cohort studies and their affiliated investigators that focus on cancer etiology and outcome research. The organization's membership grew markedly from 10 cohort studies at its inception in 2001 to 59 cohort studies at the time of the launch of the Consortium's strategic planning in 2017. This paper describes the strategic planning process that was conducted to establish organizational goals and to develop strategies and activities consistent with the Consortium's mission. The process involved a 2-year iterative approach combining surveys and in-person meetings. The resulting goals focus on communication, career development, research facilitation, scientific gaps, and common scientific challenges. The NCI Cohort Consortium's strategic plan and evaluation of its progress will advance new initiatives in cancer etiology and survivorship research.

Trends in Patient Volume by Hospital Type and the Association of These Trends With Time to Cancer Treatment Initiation.

Importance: Increasing demand for cancer care may be outpacing the capacity of hospitals to provide timely treatment, particularly at referral centers such as National Cancer Institute (NCI)-designated and academic centers. Whether the rate of patient volume growth has strained hospital capacity to provide timely treatment is unknown. Objective: To evaluate trends in patient volume by hospital type and the association between a hospital's annual patient volume growth and time to treatment initiation (TTI) for patients with cancer. Design, Setting, and Participants: This retrospective, hospital-level, cross-sectional study used longitudinal data from the National Cancer Database from January 1, 2007, to December 31, 2016. Adult patients older than 40 years who had received a diagnosis of 1 of the 10 most common incident cancers and initiated their treatment at a Commission on Cancer-accredited hospital were included. Data were analyzed between December 19, 2019, and March 27, 2020. Exposures: The mean annual rate of patient volume growth at a hospital. Main Outcomes and Measures: The main outcome was TTI, defined as the number of days between diagnosis and the first cancer treatment. The association between a hospital's mean annual rate of patient volume growth and TTI was assessed using a linear mixed-effects model containing a patient volume × time interaction. The mean annual change in TTI over the study period by hospital type was estimated by including a hospital type × time interaction term. Results: The study sample included 4 218 577 patients (mean [SD] age, 65.0 [11.4] years; 56.6% women) treated at 1351 hospitals. From 2007 to 2016, patient volume increased 40% at NCI centers, 25% at academic centers, and 8% at community hospitals. In 2007, the mean TTI was longer at NCI and academic centers than at community hospitals (NCI: 50 days [95% CI, 48-52 days]; academic: 43 days [95% CI, 42-44 days]; community: 37 days [95% CI, 36-37 days]); however, the mean annual increase in TTI was greater at community hospitals (0.56 days; 95% CI, 0.49-0.62 days) than at NCI centers (-0.73 days; 95% CI, -0.95 to -0.51 days) and academic centers (0.14 days; 95% CI, 0.03-0.26 days). An annual volume growth rate of 100 patients, a level observed at less than 1% of hospitals, was associated with a mean increase in TTI of 0.24 days (95% CI, 0.18-0.29 days). Conclusions and Relevance: In this cross-sectional study, from 2007 to 2016, across the studied cancer types, patients increasingly initiated their cancer treatment at NCI and academic centers. Although increases in patient volume at these centers outpaced that at community hospitals, faster growth was not associated with clinically meaningful treatment delays.

Rethinking Cancer Clinical Trial Conduct Induced by COVID-19: An Academic Center, Industry, Government, and Regulatory Agency Perspective.

The COVID-19 pandemic brought about major changes in cancer clinical trials. In its aftermath, the community has an opportunity to incorporate some of these changes as part of the future of trial conduct to make it more patient centered.

Assessing Electronic Nicotine Delivery Systems Use at NCI-Designated Cancer Centers in the Cancer Moonshot-funded Cancer Center Cessation Initiative.

Assessing tobacco product use and delivering tobacco dependence treatment is an essential part of cancer care; however, little is known about electronic nicotine delivery systems (ENDS) or e-cigarette use assessment in cancer treatment settings. Given the importance of tailoring tobacco treatment, it is critical to understand how ENDS use is assessed in the electronic health record (EHR) in cancer care settings. Two questionnaires were completed by tobacco treatment program leads at 42 NCI-Designated Cancer Centers in the Cancer Center Cessation Initiative (January 1 to June 30 and July 1 to December 31, 2019). Items assessed how often smoking status and ENDS use were recorded in the EHR. An open-ended item recorded the text and response categories of each center's ENDS assessment question. All 42 centers assessed smoking status at both time periods. Twenty-five centers (59.5%) assessed ENDS use in the first half of 2019, increasing to 30 (71.4%) in the last half of 2019. By the end of 2019, 17 centers assessed smoking status at every patient visit while six assessed ENDS use at every visit. A checkbox/drop-down menu rather than scripted text was used at 30 centers (73.2%) for assessing smoking status and at 18 centers (42.9%) for assessing ENDS use. Our findings underscore the gap in systematic ENDS use screening in cancer treatment settings. Requiring ENDS use measures in the EHR as part of quality measures and providing scripted text scripts to providers may increase rates of ENDS use assessment at more cancer centers. PREVENTION RELEVANCE: This study identifies a gap in the systematic assessment of ENDS use among patients seen at 42 NCI-Designated cancer centers. Requiring the systematic assessment of both ENDS use and use of other tobacco products can inform evidence-based treatment of tobacco dependence and lead to improved cancer treatment outcomes.

Understanding a Diverse Cancer Center Catchment Area: A Qualitative Needs Assessment Built on a Theoretical Framework.

INTRODUCTION: Quantitative approaches to the cancer incidence and mortality of a geographic region may lack understanding of the human context in the region thereby affecting how relevant cancer prevention and control activities can best be targeted to a cancer center's catchment area. OBJECTIVES: The objective of this study was to obtain and analyze qualitative data that described the barriers and facilitators in a cancer center's catchment area. A further objective was to use the assessment to plan a comprehensive approach to cancer prevention and control activities in the region. METHODS: Extensive qualitative data were gathered from 32 key informants in the 13 county catchment area. We used the Warnecke Model for Analysis of Population Health and Health Disparities to analyze the qualitative data. We coded factors affecting cancer prevention and control using a directed content analysis approach guided by the Warnecke Model. RESULTS: Four outcome types included fundamental barriers such as political environment and discrimination, gaps in resources, and lack of coordinated activities. Social and physical barriers included distrust, diverse language and cultures, and geographic distance. Individual barriers included lack of system negotiation, health literacy, and poverty. Biological barriers were disparate disease rates in specific groups. CONCLUSION: The analysis and assessment led to the creation of a catchment area wide coalition that used the results to formulate a comprehensive strategic plan to address the barriers in the region.

NCI's Work to Advance Cancer Research while Responding to the COVID-19 Pandemic.

During the COVID-19 pandemic, the National Cancer Institute (NCI) is bringing to bear its considerable expertise and capabilities to understand, treat, and prevent the disease. While responding to the pandemic, NCI's priority remains the advancement of cancer research. NCI has implemented many flexibilities for grantees and trainees.

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 solid progress of nanomedicine.

This commentary article conveys the views of the board of the Nanomedicine and Nanoscale Delivery Focus Group of the Controlled Release Society regarding the decision of the United States National Cancer Institute (NCI) in halting funding for the Centers of Cancer Nanotechnology Excellence (CCNEs), and the subsequent editorial articles that broadened this discussion. Graphical abstract.

The 'Good Friday Agreement' and cancer research on the island of Ireland: Evidence for the impact of a tripartite cancer research partnership.

AIM: In 1999, a cooperative tripartite cancer research and training agreement was signed between Ireland (IE), Northern Ireland (NI) and the United States (US) National Cancer Institute, giving rise to the All-Ireland Cancer Consortium (AICC). We wished to consider if AICC increased the amount/impact of cancer research on the island of Ireland and what effect this enhanced research activity had on cancer services and cancer outcomes. METHODS: As comparator, we chose the city regions of Copenhagen and Lund & Malmö, whose physical connection was greatly improved following construction of bridges between Denmark and Sweden around the time AICC was established. We analysed cancer research outputs from all four geographical regions in the Web of Science (1988-2017), with a particular focus on citations and journal impact factors. We evaluated disability-adjusted life years (DALYs) as an indicator of change in health status. RESULTS: Research outputs increased in all four regions, but more in IE/NI than in the Scandinavian cities, while collaboration between IE and NI and both the US and the Rest of Europe increased even more substantially. Citation scores also showed a greater improvement for IE and NI. Journal citation impact factors indicated that IE/NI papers were increasingly being published in more highly cited journals. Research-enabled cancer service provision improved on the island of Ireland, with concomitant increases in cancer survival. CONCLUSION: The AICC collaborative agreement delivered significant additionality on the island of Ireland, promoting transnational cooperation, enhancing cancer research activity, and underpinning improved cancer services and better cancer outcomes.

Enrollment of adolescents and young adults onto SWOG cancer research network clinical trials: A comparative analysis by treatment site and era.

BACKGROUND: Few adolescents and young adults (AYAs, 15-39 years old) enroll onto cancer clinical trials, which hinders research otherwise having the potential to improve outcomes in this unique population. Prior studies have reported that AYAs are more likely to receive cancer care in community settings. The National Cancer Institute (NCI) has led efforts to increase trial enrollment through its network of NCI-designated cancer centers (NCICC) combined with community outreach through its Community Clinical Oncology Program (CCOP; replaced by the NCI Community Oncology Research Program in 2014). METHODS: Using AYA proportional enrollment (the proportion of total enrollments who were AYAs) as the primary outcome, we examined enrollment of AYAs onto SWOG therapeutic trials at NCICC, CCOP, and non-NCICC/non-CCOP sites from 2004 to 2013 by type of site, study period (2004-08 vs 2009-13), and patient demographics. RESULTS: Overall, AYA proportional enrollment was 10.1%. AYA proportional enrollment decreased between 2004-2008 and 2009-2013 (13.1% vs 8.5%, P < .001), and was higher at NCICCs than at CCOPs and non-NCICC/non-CCOPs (14.1% vs 8.3% and 9.2%, respectively; P < .001). AYA proportional enrollment declined significantly at all three site types. Proportional enrollment of AYAs who were Black or Hispanic was significantly higher at NCICCs compared with CCOPs or non-NCICC/non-CCOPs (11.5% vs 8.8, P = .048 and 11.5% vs 8.6%, P = .03, respectively). CONCLUSION: Not only did community sites enroll a lower proportion of AYAs onto cancer clinical trials, but AYA enrollment decreased in all study settings. Initiatives aimed at increasing AYA enrollment, particularly in the community setting with attention to minority status, are needed.

The National MDS Natural History Study: design of an integrated data and sample biorepository to promote research studies in myelodysplastic syndromes.

Myelodysplastic syndromes (MDS), a spectrum of heterogeneous hematopoietic stem cell diseases, vary in clinical severity, response to therapy, and propensity toward progression to acute myeloid leukemia. These are acquired clonal disorders resulting from somatic mutations within the hematopoietic stem or progenitor cell population. Understanding the natural history and the risk of developing leukemia and other adverse outcomes is dependent on access to well-annotated biospecimens linked to robust clinical and molecular data. To facilitate the acquisition and distribution of MDS biospecimens to the wider scientific community and support scientific discovery in this disease, the National MDS Natural History study was initiated by the National Heart, Lung, and Blood Institute (NHLBI) and is being conducted in collaboration with community hospitals and academic medical centers supported by the National Cancer Institute (NCI). The study will recruit up to 2000 MDS patients or overlapping myeloproliferative neoplasms (MDS/MPN) and up to 500 cases of idiopathic cytopenia of undetermined significance (ICUS). The National MDS Natural History Study (NCT02775383) will offer the world's largest disease-focused tissue biobank linked to longitudinal clinical and molecular data in MDS. Here, we report on the study design features and describe the vanguard phase of 200 cases. The study assembles a comprehensive clinical database, quality of life results, laboratory data, histopathology slides and images, genetic information, hematopoietic and germline tissues representing high-quality biospecimens and data from diverse centers across the United States. These resources will be available to the scientific community for investigator-initiated research.

National Cancer Institute Centers and Society of Surgical Oncology Cancer Research Synergy.

BACKGROUND: The objective of this study was to examine the influence of Surgical Society Oncology (SSO) membership and National Cancer Institute (NCI) status on the academic output of surgical faculty. METHODS: NCI cancer program status for each department of surgery was identified with publically available data, whereas SSO membership was determined for every faculty member. Academic output measures such as NIH funding, publications, and citations were analyzed in subsets by the type of cancer center (NCI comprehensive cancer center [CCC]; NCI cancer center [NCICC]; and non-NCI center) and SSO membership status. RESULTS: Of the surgical faculty, 2537 surgeons (61.9%) were from CCC, whereas 854 (20.8%) were from NCICC. At the CCC, 22.7% of surgeons had a history of or current NIH funding, compared with 15.8% at the NCICC and 11.8% at the non-NCI centers. The academic output of SSO members was higher at NCICC (52 ± 113 publications/1266 ± 3830 citations) and CCC (53 ± 92/1295 ± 4001) compared with nonmembers (NCICC: 26 ± 78/437 ± 2109; CCC: 37 ± 91/670 ± 3260), respectively, P < 0.05. Multivariate logistic regression revealed that SSO membership imparts an additional 22 publications and 270 citations, whereas NCI-designated CCC added 10 additional publications, but not citations. CONCLUSIONS: CCCs have significantly higher academic output and NIH funding. Recruitment of SSO members, a focus on higher performing divisions, and NIH funding are factors that non-NCI cancer centers may be able to focus on to improve academic productivity to aid in obtaining NCI designation.

The NCI Physical Sciences - Oncology Network.

Nastaran Zahir is Associate Director of the Physical Sciences - Oncology Network in the Division of Cancer Biology at the National Cancer Institute. Dr. Zahir coordinates cross-cutting efforts to integrate physical sciences perspectives with cancer research by fostering transdisciplinary research collaborations, supporting education and outreach programs, and promoting resources for data sharing and biospecimen standards.

A New Framework for Patient Engagement in Cancer Clinical Trials Cooperative Group Studies.

For the past two decades, the National Cancer Institute (NCI) has supported the involvement of patient advocates in both internal advisory activities and funded research projects to provide a patient perspective. Implementation of the inclusion of patient advocates has varied considerably, with inconsistent involvement of patient advocates in key phases of research such as concept development. Despite this, there is agreement that patient advocates have improved the patient focus of many cancer research studies. This commentary describes our experience designing and pilot testing a new framework for patient engagement at SWOG, one of the largest cancer clinical trial network groups in the United States and one of the four adult groups in the NCI's National Clinical Trials Network (NCTN). Our goal is to provide a roadmap for other clinical trial groups that are interested in bringing the patient voice more directly into clinical trial conception and development. We developed a structured process to engage patient advocates more effectively in the development of cancer clinical trials and piloted the process in four SWOG research committees, including implementation of a new Patient Advocate Executive Review Form that systematically captures patient advocates' input at the concept stage. Based on the positive feedback to our approach, we are now developing training and evaluation metrics to support meaningful and consistent patient engagement across the SWOG clinical trial life cycle. Ultimately, the benefits of more patient-centered cancer trials will be measured in the usefulness, relevance, and speed of study results to patients, caregivers, and clinicians.

New Horizons in Advocacy Engaged Physical Sciences and Oncology Research.

To address cancer as a multifaceted adaptive system, the increasing momentum for cross-disciplinary connectivity between cancer biologists, physical scientists, mathematicians, chemists, biomedical engineers, computer scientists, clinicians, and advocates is fueling the emergence of new scientific frontiers, principles, and opportunities within physical sciences and oncology. In parallel to highlighting the advances, challenges, and acceptance of advocates as credible contributors, we offer recommendations for addressing real world hurdles in advancing equitable partnerships among advocacy stakeholders.

Incorporating Digital Tools to Improve Clinical Trial Infrastructure: A White Paper From the Digital Engagement Committee of SWOG.

Progress toward improvement in cancer therapy relies on clinical trials. Yet, only a minority of eligible patients with cancer enroll as a result of multiple barriers at the patient, investigator, center, and national level. However, the rise of the Internet and mobile technology has created a slew of tools with medical applications, from Web sites to apps to social media platforms, all of which may aide clinicians in our quest to improve the clinical research enterprise. SWOG is one of five members in the National Cancer Institute's National Clinical Trials Network-the nation's oldest and largest publicly funded cancer research network-and is taking a leadership role in exploring and testing the promise of digital engagement through the empaneling of the Digital Engagement Committee. This article outlines the mission, principles, and priorities of the Digital Engagement Committee and proposes how this work may inform the use of digital tools for the cancer research community and, hopefully, translate to improved outcomes for our patients.