National Cancer Institute Community Cancer Centers Program Sites Research Articles

The National Cancer Institute Community Cancer Centers Program (NCCCP): Sustaining Quality and Reducing Disparities in Guideline-Concordant Breast and Colon Cancer Care.

The 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. We 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. The 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. Quality 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. Quality 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.

Experience of the National Cancer Institute Community Cancer Centers Program on Community-Based Cancer Clinical Trials Activity.

A goal of the National Cancer Institute Community Cancer Centers Program (NCCCP) was to improve cancer research capacity in community settings. We examined research capacity development during the pilot phase of the NCCCP within the context of national trends in clinical trial activity with respect to the number and phase of trials, total accrual, and accrual of underserved populations. We examined self-reported data from NCCCP sites during 2007 to 2010, supplemented with data from the National Cancer Institute Cancer Therapy Evaluation Program. Trial availability and accrual improved more quickly at NCCCP sites compared with national trends. Phase III trial availability increased 8% nationally versus 16% across NCCCP sites, and accrual increased 30% nationally versus 133% across NCCCP sites. Accrual of racial and ethnic minorities rose 82%, from 83 to 151 patients, and accrual of patients age ≥ 65 years rose by 221%, from 200 to 641 patients. Change in trial portfolio and accrual differed by sophistication of the site and by prior experience in conducting clinical trials at the site. Despite the short duration, the NCCCP pilot resulted in an increase in the number of open trials as well as patient accrual at a faster rate than that observed nationally. These results, coupled with insights into the relative success of sites with varying sophistication at the outset, provide promise that lessons learned can be applied more broadly to increase research participation.

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

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. 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. 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. 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.

The cancer psychosocial care matrix: a community‐derived evaluative tool for designing quality psychosocial cancer care delivery

Although the Institute of Medicine provided a vision for effective psychosocial care for cancer survivors, limited guidance exists regarding the essential components of comprehensive care or progressive steps for implementing each component. This paper describes the development of a unique tool for assessing capacity to provide quality psychosocial care to cancer survivors and the results of the first implementation of this tool in community settings. The psychosocial working group of the National Cancer Institute Community Cancer Centers Program (NCCCP) developed the Cancer Psychosocial Care Matrix assessment tool. All NCCCP sites (n=30, enrolled in 2007 nd 2010) completed the matrix indicating their capacity for providing psychosocial care at entry into NCCCP ('baseline') after 2 years of NCCCP participation (2007 sites only) and within the coming year ('future aspirations'). At baseline, matrix responses reflected few or no systematic processes in place for most components of comprehensive psychosocial care. However, reported capacity to deliver specific components improved at 2 years post-NCCCP entry for the 2007 sites and in all NCCCP sites' future aspirations. With growing demand on cancer centers to meet new metrics of quality care, the psychosocial matrix can help centers systematically identify and develop steps to address gap areas in their capacity to meet these new standards. The Cancer Psychosocial Care Matrix appears to enable evaluation of psychosocial programs, may promote intentions to improve psychosocial services, and can facilitate communication of 'best practices' among cancer centers.

The psychosocial matrix: A community-derived evaluative tool for designing quality psychosocial cancer care.

250 Background: Although the Institute of Medicine provided a vision for effective psychosocial care for cancer survivors, guidance regarding the essential components of comprehensive care or progressive steps for implementing each component is limited. This abstract presents a unique tool for self-assessing capacity to provide quality psychosocial care to cancer survivors and results of the first full-scale implementation of this tool. Methods: The psychosocial workgroup of the National Cancer Institute Community Cancer Centers Program (NCCCP) developed the Psychosocial Care Matrix Assessment Tool which covers 7 domains (e.g., distress screening, patient-provider communication, evaluation of psychosocial programs). All NCCCP sites (16 enrolled in 2007, 14 enrolled in 2010) completed the matrix in 2010 regarding their capacity for psychosocial care at entry into NCCCP (baseline), after two years of NCCCP participation (2007 sites only), and within the coming year (future aspirations). Results: At baseline, matrix responses reflected few or no systematic processes in place for most components of psychosocial care. However, reported capacity to deliver specific components improved at two years post-NCCCP entry for the 2007 sites and in all sites’ future aspirations. For example, about 80% of all sites reported no or inconsistent distress screening at baseline. After two years, 48% of the 2007 sites reported consistent screening with a standardized tool or consistent screening plus a comprehensive interview. Nearly all 2007 sites (89%) aspired to provide consistent screening plus comprehensive interview with 50% also hoping to add systematic follow-up screenings. The majority of 2010 sites (71%) aspired to provide consistent screening with a standardized tool. Conclusions: The psychosocial matrix tool was found to be useable and valuable. At the NCCCP sites, some aspects of psychosocial care (e.g., communicating the importance of psychosocial care) are more readily implemented than others (e.g., follow-up after a positive distress screen). With growing demand on cancer centers to meet new metrics of quality care, the psychosocial matrix can help identify and develop steps to address gap areas.

The oncology palliative care matrix: A community-derived evaluation tool for constructing oncology palliative care programs.

253 Background: While the Institute of Medicine and the Center to Advance Palliative Care have provided the impetus for many cancer centers to build palliative care programs, guidance regarding the “nuts and bolts” of program development is lacking. The Oncology Palliative Care Matrix (OPCM) is a unique self-assessment tool designed to facilitate both program evaluation and planning for provision of oncology palliative care. Methods: The National Cancer Institute Community Cancer Centers Program (NCCCP) Palliative Care Working Group developed the OPCM to assess palliative care capacity. The tool covers 17 components associated with quality palliative care delivery (e.g., staff training, patient identification, advanced care planning, attention to spiritual care). All NCCCP sites (16 enrolled in 2007, 14 enrolled in 2010) completed the matrix in 2010 evaluating their capacity with respect to each of these domains at the following time points: baseline (entry to the NCCCP program), 2 years after NCCCP enrollment (2007 sites only), and the upcoming year (goals for the future). Results: At baseline, matrix responses reflected variability in service capacity across the 17 domains. Reported capacity for specific palliative care components improved for the 2007 sites after 2 years in NCCCP; all sites identified ‘reach’ goals for the coming year. For example, at baseline, 63% of 2007 sites and 50% of 2010 sites referred only patients at end-of-life or with advanced disease and severe symptoms for palliative care services. However, after 2 years in NCCCP, 44% of 2007 sites still referred only these patients, while 56% made referrals to palliative care for patients at all cancer stages and/or as needed during post-treatment. Further, 100% of 2007 sites and 86% of 2010 sites aspired to this expanded referral capacity in the future. Conclusions: The OPCM shows utility in the community setting for self-assessment of capacity and strategic planning to improve quality palliative care delivery. It also highlights that some components of quality care may be easier to achieve/improve (e.g., referral for palliative care) than others (e.g., regular symptom assessment, palliative care staff support).

Increasing genetics referrals: The National Cancer Institute Community Cancer Centers Program (NCCCP) network performance improvement project.

111 Background: A NCCCP goal is to improve quality of care through increasing guideline adherence at participating community cancer centers. 14 NCCCP sites participated in a performance improvement project to (1) increase genetics referral and counseling services by 10% in accordance with established guidelines for breast or colorectal cancer. The project hypothesized that data collection and feedback improves referral rates by better targeting eligible populations for improvement interventions. Methods: Sites recorded the source and outcome of each breast/colon referral using a tool developed by the NCCCP. Aggregate data were shared on monthly project calls where site staff shared best practices/issues with peers and received feedback. Results: Data were collected Jul 2011-Apr 2012 and analyzed at 2-week intervals. The number of colorectal and breast patients referred for genetics counseling remained stable through the 9-month period. Despite no change in the rates of referrals the data were hypotheses generating. Colorectal cases of all ages were being correctly referred in accordance with established guidelines; project calls demonstrated sites’ efforts to improve referral processes, such as including genetics counselors in the multidisciplinary team discussions, implementing universal screening for Lynch syndrome, and developing new linkages with referring staff. Conclusions: The project was a successful proof of concept study showing the feasibility of pooling genetic counseling data across diverse community cancer centers. Robust data collection is inadequate to drive sustainable improvement; specific process changes are also required. Future NCCCP collaborative initiatives are needed to ensure all eligible patients have access to genetic counseling referral services as there remain a significant group of patients eligible for genetic counseling who are not being seen. Funded by HHSN261200800001E.

Early-phase (EP) clinical trials (CTs) in the community: Results from the National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) Early-Phase Working Group (EPWG) Baseline Assessment Study (BAS).

e16561 Background: The NCCCP is a network of 30 community cancer center (CCC) sites that strive to expand cancer research capacity and deliver advanced care in the community. The EPWG was formed to facilitate NCCCP site participation in EP (phase I-II) CTs, thus allowing patients (pts) to be treated within their communities. This study describes the CT infrastructure at NCCCP sites and its association with EP accrual. Methods: A BAS was conducted to obtain data on NCCCP site CT infrastructure, funding, sponsor affiliations, and barriers to EP CTs. To evaluate EP performance, EP accruals during July 2010-June 2011 were obtained. High accruing sites were those with EP accrual above the median EP accrual per 1,000 new analytical cases seen in 2009 or 2010. Results: 27 sites, caring for ~56,000 new cancer pts annually, participated in the study. Median number of accruing EP trials/site was 6 (mean 7.4). Median EP accrual/site was 14 (mean 16). Median EP accrual rate was 7/1,000. Trials with a phase I component were open at 21 sites. Most sites (24) are members of multiple CGs (median 4) and enroll pts via the CTSU (70%). The more common barriers to EP trial implementation were related to infrastructure (59%), cost (52%), and access to trials (41%). When accrual rates to NCCCP CTEP EP trials only were analyzed, we found that between high vs low accruing sites, respectively, higher accrual rates were associated with higher number of CRAs devoted to EP trials (median 3.25 vs 1; P= .05) and lower proportion of funding from industry (median 18% vs 40%; P=.02). We did not, however, find significant associations when EP trials were examined across all sponsors. Conclusions: CCCs are capable of conducting, and actively participating in, EP trials. Infrastructure and collaborations are critical components of success. Our study provides useful information for those planning to begin EP trials in the community setting. [Table: see text]

Early success in narrowing age, gender, and racial disparities in clinical trial accrual: Targeted screening efforts through the National Cancer Institute Community Cancer Centers Program (NCCCP).

6110 Background: The NCCCP has engaged in special programs to enhance clinical trial accrual among underserved populations. These include cultural awareness webinars, nurse/lay navigators with translated consent forms and interpreters, expansion of trials in outreach sites, community site pairing, and utilization of a web-based tracking tool to monitor clinical trial screening and accrual barriers. Methods: Screening and accrual data of 19 NCI Cooperative Group trials encompassing 9 disease categories from the geographically diverse NCCCP sites was collected between March 2009 and December 2010. The data included patient demographics, trial eligibility, trial enrollment, and reasons for non-enrollment. We used Fisher’s exact test for determination of P values. This abstract addresses patient demographics. Results: Of the 1,589 patients screened during this period, 359 were enrolled, for an overall accrual rate of 23%. The accrual rates among the various demographic subsets are shown in the table. No disparity based on gender, ethnicity, or race between Whites and African Americans (P value for the latter comparison 0.59) was found and the disparity gap between the young and elderly appears narrowed when compared to historical data (3-fold difference; Murthy VH, et al JAMA 2004). Conclusions: NCCCP has captured clinical trial screening and accrual outcome among several underserved populations coming from diverse geographic locations. Data suggests that through barrier identification and a concerted program of network strategies involving community cancer centers, disparities in clinical trial accrual have been reduced. This project funded in whole or part with federal funds from NCI, NIH under Contract No. HHSN261200800001E. # Screened # Enrolled Accrual rate (%) P Overall 1,589 359 23 -- Female 1,078 246 23 0.80 Male 511 113 22 Age > 65 689 143 21 0.09 < 65 883 216 25 Hispanic 93 20 22 0.80 Non-Hispanic 1,465 339 23 White 1,309 306 23 0.59 African American 205 44 22

Strategies and benefits to effectively engage minority patients in their cancer care.

e19501 Background: The National Cancer Institute Community Cancer Centers Program (NCCCP), a public-private research partnership with 16 community hospital cancer centers in 14 states, directs 40% of its NCI funding on efforts to reduce healthcare disparities. These cancer centers work with private practice physicians to provide care to cancer patients. The NCCCP seeks to reduce barriers for minority populations to: improve access to cancer care, increase understanding about this care, expand accrual to clinical trials, and offer support for navigating the health care system. These efforts support many of the priorities noted in the June 2009 ASCO Policy Statement: Disparities in Cancer Care and offer approaches that can be adopted by other cancer care providers. Methods: The strategies which will be presented have been developed and tested at many NCCCP sites and include programs to improve: race and ethnicity tracking, cultural awareness education, accrual to clinical trials, and targeted minority outreach efforts. Tools and resources which support these efforts will be discussed and are available on the NCI web site (http://ncccp.cancer.gov/About/Progress.htm). Results: The NCCCP sites will show that they have been able to develop outreach and screening to target specific minority groups, increase the number of patients screened for clinical trials, increase staff training on cultural awareness, and increase race and ethnicity tracking. The benefits to providers in adopting these strategies will be discussed and include: improved participation in clinical trials programs, being able to engage patients more effectively for improved compliance with their treatment, and increased patient satisfaction. Conclusions: These strategies and programs are being used in many different community settings to improve access to care and improved quality of care for minority cancer patients and can be easily adapted to other locations. Providers who are interested in working to reduce disparities in cancer care will find the experience of the NCCCP to be helpful. NCI intends to expand the NCCCP program in the spring of 2010 thus further employing these strategies to more communities to reduce cancer healthcare disparities. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genomic Health SenoRx Genomic Health

Improvement in multidisciplinary cancer care: The National Cancer Institute Community Cancer Centers Program (NCCCP) Multidisciplinary Lung Cancer Conference and Clinics.

e16539 Background: One of the goals of the NCCCP pilot is to disseminate the use of multidisciplinary case conferences/clinics (MDC) across community cancer centers. There are studies to show that MDC's translate into better patient care. We describe the use of MDC clinics and prospective tumor conferences since the inception of the NCCCP. Methods: Each NCCCP site recorded the level of lung cancer MDC integration in their program at baseline, 2007, and in December 2009. A multidisciplinary matrix tool (MDX) developed by the NCCCP site investigators was utilized (http://ncccp.cancer.gov/about/progress.htm). The tool has 7 variables including case planning, coordination of care, physician engagement, infrastructure support, financial integration, accrual to clinical trials, and medical record integration with a score of 1-5 on each variable (maximum score -35). Results: From 2007-2009, ten of 16 NCCCP sites had initiated disease specific MDC clinics and/or conferences for lung cancer. Seven have utilized MDC clinics as well as prospective tumor conferences. Three sites instituted MDC prospective tumor conferences alone. The ten sites with existing lung cancer MDC's prior to initiation of the NCCCP saw their mean score increase from 16 at baseline to 24.7. Conclusions: The NCCCP has utilized an MDX tool to describe the level of MDC care with improvement since the inception of the program. Further prospective data collection is ongoing to determine the impact on patient outcomes including time to treatment, patient satisfaction and survival. No significant financial relationships to disclose.

Tracking clinical trial accrual strategies and barriers via a Web-based screening tool

6586 Background: The National Cancer Institute Community Cancer Centers Program (NCCCP) has developed a web based tracking tool to monitor screening of patients for clinical trial participation. The system is designed to collect data from multiple research sites throughout the geographically diverse group. The log blindly collects patient demographics, successful trial entry, and reasons for trial enrollment failure. Methods: Seven NCCCP sites utilized the log during the 60 day open accrual period for the Wake Forrest WFU 07–02–03 cancer control trial (chronic lymphocytic leukemia COLD- fX) in Novermber 2008 and December 2008. Results: 327 chronic lymphocytic leukemia patients were screened mostly by chart review. 162 (50%) were eligible for study entry. 45 (14%) entered the trial. 103 (31%) eligible patients declined entry. Of the 103, 72 (70%) did not wish to participate in research, 15 (15%) had travel constraints, 5 (5%) perceived excess toxicity, 9 (9%) gave no reason. 14 (3%) eligible had their physician decline entry. Overall, 28% of eligible patients entered the trial. 165 (50%) were trial ineligible. 82 (50%) for prior therapy, 30 (18%) for co morbid conditions, 10 (6%) missed an entry time requirement, 39 (24%) have incomplete data. Conclusions: The NCCCP trial screening log successfully captures real time clinical trial participation data from a diverse network of clinical trial sites. This data base will allow future analysis of individual clinical trial and site accrual barriers and empower strategies to increase trial participation. No significant financial relationships to disclose.