Thank you for giving me the opportunity to update you on NCI’s Community Cancer Centers Program. The NCCCP is a pilot program started by Dr. Niederhuber with it’s main intent to reach the cancer patients in the communities within which they live. He wanted to expand the reach of the resources the NCI can provide to the community setting and study the needs of this component of cancer care in order to improve quality of care, impact disparities and improve accrual to clinical research. The NCCCP program is just about to start its 4th year.

Imaging Face-to-faceMay 11, 2010

Brenda R. Duggan, RN, BSNCommunity Informatics Program ManagerNCI Community Cancer Centers Program

NCI Community Cancer Centers

Program – Overview

Presentation Overview

• Today I will provide an overview of the National Community Cancer Center Program

• We have had an expansion recently, so I will share the plans for the next generation of the program

• Then I will cover a few of the site’s imaging projects

• Overview of the NCCCP• A view of the sites • Progress to date• What’s next• NCCCP Imaging Projects

National Community Cancer Center Program (NCCCP)

The NCI Community Cancer Centers Program (NCCCP) is designed to create a community-based cancer center network to support basic, clinical and population-based research initiatives, addressing the full cancer care continuum—from prevention, screening, diagnosis, treatment, and survivorship through end-of-life care.

Shift in Cancer Treatment Paradigm

The differences between 20th century paradigm and the new paradigm:• ‘Search and Destroy’

has become ‘Target and Control’

• Reactive has become Proactive

• Based on gross differences has become Rational/Targeted

• Toxic (MTD/DLT) has become No/Low Toxicity

• Emerging resistance has become Resistance unlikely

• Poor QOL has become Improved QOL

• The reality of cancer treatment is that approximately 85% of patients are treated in their local communities.

• This is possible because there has been a shift in how cancer is treated.

• Many of today’s therapies are targeted and have lower toxicities.

• With leading edge technology and well-trained medical specialists, community hospitals now provide a sophisticated level of care, including advanced cancer treatment and access to clinical trials.

• However, a result of this advance is that in many places, cancer care has become fragmented—patients have surgery in an outpatient facility, go to a clinic for radiation therapy, and can receive chemotherapy at home.

• What we found in the community setting was that:• Practice patterns and quality were not always optimal• Disparities impact care significantly, which is a

continued national challenge • There is limited research within community setting…in

fact only 3% of adults accrued to cancer trials• Expanding science requires new approaches,

infrastructure, connections

20th Century Paradigm New Paradigm

‘Search and Destroy’ ‘Target and Control’

Reactive Proactive

Based on gross differences Rational/Targeted

Toxic (MTD/DLT) No/Low Toxicity

Emerging resistance Resistance unlikely

Poor QOL Improved QOL

Cancer Continuum

Prevention Screening Treatment Palliative Care Follow-up Survivor Support End-of-life Care

• The core components of NCCCP include columns of:

• Disparities • Clinical trails• Advocacy• Bio-specimens• Survivorship• Quality of care• caBIG EMR

• Across the columns of NCCCP, three common things are present:

• Disparities• Quality of care• caBIG (IT)

• The Cancer Continuum consists of:• Prevention• Screening• Treatment • Palliative care• Follow-up• Survivor support• End of life care

• One of the goals of the pilot program is to address this fragmentation of care many cancer patients experience in the community setting.

• As depicted on the bottom of this slide, the pilot’s core components address the full cancer continuum, from prevention through end-of-life care.

• The core components of the program include disparities, clinical trials, advocacy, biospecimens, survivorship, quality of care, caBIG tools and electronic medical records.

• Another key feature of the program is that disparities, quality of care and IT are being addressed across the cancer continuum and within each core component of the program.

NCCCP’s Core ComponentsAddress the Full Cancer Continuum

NCCCP

Disparities Clinical Trials

caBIG

EMRBio-

specimensSurvivorship Quality of

CareAdvocacy

Disparities

Quality of Care

caBIG (IT)

NCCCP Interacts with and Complements Many NCI Initiatives

• Between the Cancer Continuum and the NCCCP, the interaction involves:

• Clinical Trails• Cancer center program• Community Clinical Oncology Program

(CCOPs)• Minority-Based Community Clinical Oncology

Program (MB-CCOPs)• Cooperative Groups• Cancer Trials Support Unit (CTSU)

• Disparities• Cancer Centers Program• Community Network Program (CNP)• Cancer Disparities Research Partnership

Program (CDRP)• Patient Navigation Research Program (PNRP)• Cancer Information Service (CIS)

• Biospecimens• Cancer Centers Program• NCI Best Practices for Biospecimen Resources• The Cancer Genome Atlas

• Information Technology• Cancer Centers Program• caBIG (cancer Biomedical Informatics Grid)• Electronic Medical –HHS

• The program interacts with and complements many NCI initiatives.

• Current interactions include all programs listed, and we continue to explore collaborations with and integrate other NCI programs

Cancer Centers Program

Community Clinical Oncology Program

(CCOPs)

Minority-Based Community Clinical Oncology Program

(MB-CCOPs)

Cooperative Groups

Cancer Trials Support Unit

(CTSU)

Cancer Centers Program

CommunityNetwork Program

(CNP)

Cancer Disparities Research Partnership

Program (CDRP)

Patient NavigationResearch Program

(PNRP)

Cancer Information Service (CIS)

Cancer Centers Program

NCI Best Practicesfor Biospecimen

Resources

The CancerGenome Atlas

Cancer Centers Program

caBIGTM

(cancer Biomedical Informatics GridTM)

Electronic Medical Records–HHS

Clinical Trials

InformationTechnology

BiospecimensDisparities

NCI Community Cancer Centers Program

Cancer ContinuumPrevention Screening Treatment Palliative Care Follow-up Survivor Support End-of-life Care

• The NCCCP is different from other NCI programs in that:• It integrates activities in disparities, quality of care and

IT across the cancer continuum• It creates linkages with and integrates many NCI

programs, and • Incorporates how the knowledge gained from those

programs can be translated into a community setting• It creates a strong hospital-based community cancer

center network to support NCI goals, share best practices and form a common network

• That network is creating an infrastructure to support research by

• Providing access to patients for clinical trials, clinical data and high-quality biospecimens.

• It also involves hospital management to specifically address sustainability.

Emphasized Unique Program Attributes

• Public-Private Partnership • Local co-investment ($2.65 for every $1 NCI

dollar)• Physician-Management Partnership

• Direct involvement of hospital leadership • Networking Among Sites

• Extensive subcommittee work and sharing of best practices

• Leveraging of NCI scientific resources• NCI-designated Cancer Centers • CCOPs, MBCCOPS, CNPs, etc.

• Rigorous program evaluation methods • RTI International, independent evaluation

contractor

Specific Baseline Criteria

• The baseline criteria for site participation includes:• A distinct, hospital-based location with

integrated programs that incorporate surgery, radiation oncology and medical oncology.

• And see at least 1000 new cancer cases per year.

• The hospitals must have a commitment to addressing the underserved, including a policy that anyone diagnosed with cancer is offered treatment.

• They must have a minimum accrual of 25 patients per year, with a preference for 50.

• And must have electronic health records in place by the end of the pilot.

• Sites could not have received more than $3 Million dollars per year from NCI for the previous 3 years

• Distinct and integrated programs• At least 1,000 new cancer cases per year• Disparities – efforts and commitment to address

the underserved… policy that anyone diagnosed is offered treatment

• Clinical Trials – minimum enrollment of 25 with preference for 50

• Information Technology – EHR plans underway • NCI Funding -- Less than $3M / year

NCCCP Sites

NCCCP is a network of community cancer centers working to expand cancer research and deliver advanced care to a greater number of Americans

• NCCCP is currently in its pilot phase, with 30 community cancer centers, 14 of which were added in May of 2010

• Each NCCCP community cancer center will see at least 1,000 new cancer cases each year

• NCCCP seeks to:• Reduce cancer health disparities• Improve quality of care in community

settings• Increase participation in clinical trials• Enhance survivorship and palliative care• Participate in biospecimen research

initiatives• Expand use of EHRs• Enhance cancer advocacy

• As I said earlier, the NCCCP just recently expanded it’s network to 30 sites. It represents a fairly well weighted cross-section across the country now, adding additional sites in the west and in the mid-west.

NCCCP Sites – Original 16

• In the original 16 sites, 10 organizations were selected from across the county:

• 6 are community hospitals in both urban and semi-rural areas,

• 2 are rural hospitals that include Native American populations,

• And 2 are national health systems that were included to study how these organizations disseminate information and practices of the program to developmental sites that do not meet the baseline criteria.

• So although 10 organizations are funded, there are 16 hospitals participating in the pilot.

• 6 Community Hospitals• Hartford Hospital, CT• St. Joseph’s/Candler, GA• Our Lady of the Lake Regional Medical Center, LA• Spartanburg Regional Hospital, SC• St. Joseph Hospital, Orange, CA• Christiana Hospital, DE

• 2 Rural Hospitals – Native American• Billings Clinic, MT• Sanford USD Medical Center, SD

• 2 National Health Systems: multistate with multiple program sites• Ascension Health of St. Louis, MO (1 lead and 2 developmental

sites)• Catholic Health Initiatives of Denver, CO (2 lead and 3

developmental sites)

NCCCP Sites – New 14

• Norton Suburban Hospital – Louisville, KY• The Queen’s Medical Center – Honolulu, Hawaii• Lehigh Valley Hospital – Allentown, Pennsylvania• Geisinger Medical Center – Danville, Pennsylvania • Saint Mary’s Health Care – Grand Rapids, Michigan• Northside Hospital – Atlanta, Georgia• Providence Portland Cancer Center – Portland, Oregon• St. Joseph Mercy Hospital – Ann Arbor Michigan• Albert Einstein Medical Center – Philadelphia, Pennsylvania• Maine Medical Center, Portland, Maine• Gundersen Lutheran Medical Center – LaCrosse, WI• St. Luke’s RMC – Boise, ID• Waukesha Memorial Hospital – Waukesha, WI• Mercy Medical Center – Des Moine, Iowa

With the recent addition of these 14 sites, we have a very good representation of community cancer centers in the united states.

Sites Provide a Good Study Group

• 60,000 new cancer cases per year

• Broad range of:• Program maturity and size • Geographic and community settings• Different structures and medical

staff employment arrangements• Strengths and areas for

improvement

• Ability to contribute expertise to pilot group

• The sites provide a good study group in that:

• They see approximately 60,000 new cancer cases per year.

• Knowing that what will work in one community setting will not necessarily work in another, the sites were chosen to represent a broad range across the key components of the program.

• These included differences in the level of program maturity and size, geographic and community settings, and structures and medical staff employment arrangements, with most hospitals utilizing private practice physicians while others include hospital-employed physicians.

• Each site has unique strengths and areas for improvement, and are sharing their expertise to create a strong network of sites.

Progress to DateCollaboration to Build an NCCCP Network

Shared best practices/technical assistance• Many visits to other pilot sites, connections across sites,

tools and policies exchangedDevelop, utilize and evaluate NCCCP Tools• Clinical Trials Accrual Tracking Tool• Breast Screening Tracking Tool• Breast Cancer Adjuvant Treatment Summary Tool• Breast Cancer Survivorship Care Plan• Multidisciplinary Care Matrix Assessment Tool• Chemotherapy Consent Form• Cancer Center Physician Conditions of Participation• Genetic Counseling Assessment Tool• Biospecimen Assessment Tools

• One of the cornerstones of the program is to create a vibrant network to support research and improve quality of care

• The sites are actively building the network through sharing best practices and providing technical assistance to one another.

• In addition, they have worked together through subcommittees to develop “NCCCP Tools” to help measure progress to meet the deliverables.

• Draft documents are provided in the Board Book and once evaluated, we plan to post these tools on the website for non-NCCCP sites’ use.

• The pilot sites are utilizing these tools to evaluate their programs and to determine areas for improvement.

• In addition, metrics have been developed to identify changes in practice patterns and quality of care as a result of utilizing these tools over time.

Example of NCCCP Tools for Community Settings

NCCCP Tools:• Breast Screening Tracking Tool

• Purpose: Lag time between initial screening, diagnosis and care, and recruitment for clinical trails, particularly for the underserved

• Breast Survivorship Care Plan• Purpose: Guidelines for surveillance

and risk factors for potential long-term and late effects of therapy

• MDC Care Assessment Tool• Purpose: Case planning, physician

engagement, coordination of care, infrastructure, and financial considerations

• MD Conditions of Participation• Purpose: Volume of patients treated,

participation in clinical trails and in QoC initiatives, acceptance of uninsured patients, and board certification

This slide provides further detail on just a few of the tools NCCCP members have developed:• The Breast Screening Tracking Tool is being tested as

an effective mechanism for monitoring the lag time between initial screening, diagnosis and care, and recruitment for clinical trials, particularly for the underserved. One hospital used the tool and cut one week off the average time between cancer screening and follow-up.

• The Breast Cancer Survivorship Care Plan includes guidelines for surveillance, as well as a list of risk factors for potential long-term and late effects of therapy, and approaches to monitor and address these possible problems.

• The Multidisciplinary Care Assessment Tool defines an MDC model for cancer care in the community setting, and is defining integrated efforts in case planning, physician engagement, coordination of care, infrastructure, and financial considerations.

• The Physicians Conditions of Participation sets the recommended requirements for experience and performance, and includes volume of patients treated, participation in clinical trials and in quality of care initiatives, acceptance of uninsured patients, and board certification.

Tool PurposeBreast Screening Tracking Tool

Lag time between initial screening, diagnosis and care, and recruitment for clinical trials, particularly for the underserved

Breast Survivorship Care Plan

Guidelines for surveillance and risk factors for potential long-term and late effects of therapy

MDC Care Assessment Tool

Case planning, physician engagement, coordination of care, infrastructure, and financial considerations

MD Conditions of Participation

Volume of patients treated, participation in clinical trials and in QoC initiatives, acceptance of uninsured patients, and board certification

Progress to Date Collaboration to Build an NCCCP Network

Improve Quality of Patient Care

• Sharing tools, protocols, programs, and approaches to overcome barriers

• Implementing a multidisciplinary approach to care in the private practice setting

• Addressing the entire cancer continuum and disparities efforts across all pilot activities

• By building the NCCCP network, the pilot activities are anticipated to improve the quality of patient care.

• The sites are sharing tools, protocols, programs and approaches to overcome barriers,

• They are implementing a multidisciplinary approach to cancer care in the private practice setting,

• And they are addressing the entire cancer continuum and disparities across all pilot activities.

Progress to Date Collaboration to build an NCCCP Network

• This network is also Enhancing the Cancer Research Infrastructure

• Based on NCI’s Best Practices, all 16 sites have gone beyond the deliverable for biospecimens for the pilot, and are adopting optimal processes for formalin-fixation, the first necessary step for high-quality biospecimens.

• Similarly, 12 out of the 16 sites have gone beyond the IT deliverable for the pilot and are adopting or adapting caBIG resources

• Paper-based record keeping is rapidly changing as the sites move to electronic health records. The sites all participated in a joint collaborative effort with ASCO to develop the Clinical Oncology Requirements for an EHR (CORE). The sites are now in the process of working with the their vendors to begin adapting products to reflect these oncology specific needs.

• And sites have already shown increases in accrual to clinical trials.

Enhance the Cancer Research Infrastructure

• All 16 sites adopted first step of NCI Best Practices for Biospecimen Resources with formalin fixation standards for breast specimens

• 12/16 sites have adopted or are planning to adopt caBIG clinical trials, tissue, and imaging tools

• Moving to Electronic Health Records

• Increasing accrual to clinical trials

Progress to Date Collaborations in the Community

• Sites have made many new collaborations within their communities:

• This has included focusing on reaching the underserved.

• They have developed plans to work with primary care providers to improve screening.

• Expanded linkages with oncologists to coordinate care and promote research.

• Expanded community linkages for survivorship activities.

• And developed a cross-cutting disparities vision and work plan integrated across NCCCP pillars

• Made many new connections to community organizations, with a focus on reaching the underserved

• Developed plans to work with primary care providers to improve screening

• Expanded linkages with community oncologists to coordinate care and promote research

• Expanded community linkages for survivorship activities

• Developed cross-cutting disparities vision and work plan integrated across NCCCP pillars

Progress to DateCollaboration across the Cancer Enterprise

• Many collaborations across the cancer enterprise have also been created:

• The pilot hospitals are working with the American College of Surgeons Commission on Cancer to assess quality-of-care improvements against standard quality indicators.

• Through this new collaborative, the hospitals are sharing data to improve adherence to evidence-based practices.

• As a result of the pilot, the NCCCP sites worked collaboratively to develop a set of oncology specific EHR requirements, called CORE. This effort has helped inform the NCI caEHR activities and many of the NCCCP sites have recently won ARRA funding for projects to implement caEHR specifications.

• Physicians from 8 pilot sites are participating in ASCO’s Quality Oncology Practice Initiative, which is practice improvement projects for community, office-based oncology and hematology practices.

• ASC is co-sponsoring navigator training for NCCCP sites.

• And linkages between NCI-designated cancer centers and NCCCP sites have been expanded, or the sites have developed new relationships.

American College of Surgeons – CoC• Cancer quality improvement collaborative formed –utilizing

standard quality indicators for cancer diagnosis and treatment• Improve adherence to evidence-based practices

ASCO• CORE• Quality Oncology Practice Initiative—8 pilot sites

ACS• Navigator training for NCCCP sites

NCI-designated Cancer Centers• Expanded and / or developed new relationships

NCCCP / NCI-designated Cancer Linkages

• We recognize that many have concerns about how this program could overlap the NCI-designated Cancer Centers Program. The intent is that they complement one another.

• The NCCCP sites gain by having access to clinical trials for their patients, and the NCI-designated Cancer Centers gain by having access to a networked research infrastructure for access to patients for clinical trials, access to clinical data for analysis, and access to biospecimens.

• This slide also describes a couple of the successful linkages, and demonstrates that the NCCCP sites are capable of conducting early phase clinical trials and providing high-quality biospecimens.

• Five NCCCP sites have signed contracts with the Moffitt Cancer Center for the sites to collect biospecimens for Moffitt’s Total Cancer Care Initiative – Hartford Hospital had highest tissue quality of all TCC tissue source sites

• Three pilot organizations were awarded contracts for 4 NCCCP hospitals to collect prospective biospecimens for The Cancer Genome Atlas project.

Complement One Another• NCCCP Sites-Access to Clinical Trials• NCI-designated Cancer Centers-Research InfrastructureConduct Early Phase Clinical Trials• Billings Clinic with NCI-designated Cancer Centers

Provide High Quality Biospecimens• 5 NCCCP Sites and H. Lee Moffitt Cancer Center

• Contracts to collect biospecimens for Moffitt’s Total Cancer Care Initiative

• 3 organizations awarded contracts for 3 NCCCP hospitals to collect prospective biospecimens for The Cancer Genome Atlas (TCGA)

Information Technology – caBIG®

• caBIG has had a significant impact in the community setting. The strategy and planning effort has helped transform IT shops and give them the leverage they needed to support IT budget planning. Through collaboration and a true understanding of both the user workflows and how the technology will be used, informatics departments have been able to better support budget requests. The economy has served to cause sites to look for resources that can help them to achieve their business strategies at lower price points, so through the NCCCP pilot activities sites were able to explore these tools at both a high level and at a targeted individualized level, involving users. They were able to talk with other sites and users that already have these technologies in place to leverage lessons learned. The community setting have IT shops that run on shoe strings and therefore have less access to advanced IT capabilities, so being able to leverage caBIG IT resources and contracts to meet their implementation strategies enabled technology acquisition.

• For example, we were able to leverage a caBIG contract that was in place to support documentation and process improvement for installation of NBIA enabling three sites to receive the hands on assistance they needed to get NBIA up and running at their sites. Two sites are up and running now and the other one will follow in the next month, as they had some customizations they requested. caBIG was able to use these experiences to improve the documentation and develop implementation strategies in new environments. Benefit was received by both the sites and caBIG at a very low cost to the program.

• Due to the economy, we expected that over the course of the year we would experience some deadlines pushed which has occurred but delays are more like 6 months and not cancelled all together. CHI was supposed to be installing caTissue but they decided to go with a vendor solution, BioFortis, instead yet they are requiring them to become caBIG silver compatible. This brings value to the user community by providing silver level interoperable solutions expanding choice for the users. The NCCCP sites invested considerable time and effort in the planning phase of this pilot program and as such we have not seen plans cancelled all together even given the economy, proving the value and success of this detailed short and long term planning exercise. The technology solutions identified by the sites have proven integral to operations.

Challenge• caBIG ® Technology Deployment – Lack of connectivity

with national research cancer data network

Accomplishments• 12 of 16 NCCCP sites are implementing caBIG ® tools

• 4 sites have caBIG ® tools in use to date (caTissue and NBIA)

• 8 sites to implement caBIG ® tools in 2010• 6 caTissue• 1 caArray• 1 Clinical Trials Suite

Information Technology - EHR

• A second contract deliverable for the pilot sites was an implementation of an EMR and tumor registry. All sites have EMR/EHR solutions in place at the organization level. They also have tumor registries that utilize electronic data transmission. These meet the contract deliverable.

• Yet, the cancer centers realized the importance of having an EMR/EHR in place within the cancer center. Over the past 2 years the sites have worked on implementing EMR’s in the cancer center and most have put them in place now. Where the center’s struggle is in having access to oncology specific EMR/EHR solutions that integrate with oncology specific tools and their hospital’s EHR. Many of the sites with cancer center solutions have leveraged their enterprise system from the hospital. Yet these ambulatory systems lack the functionality that they need to drive oncology care, so often alternate work flows and supporting documentation is required creating paper-based shops. Clearly not ideal.

• This disparity in needs was the impetus for the participation in the ASCO, NCI, NCCCP effort to define the Clinical Oncology Requirements for EHRs (CORE). Now as we drive forward, sites are approaching their existing and new vendors to address the requirements included in CORE in their implementations.

Challenge• Electronic Health Records Deployment – Limited

implementation of EHRs and few linkages with private practice physicians

Accomplishments• Of 16 cancer centers:

• 9 have an operational EHR • 2 additional sites to deploy EHR by summer 2010• 5 have delayed implementation, citing economic conditions

• All sites have EHR in hospital to meet contract requirements

• ASCO/NCCCP Oncology EHR Whitepaper – Oct 2009

Where We Are Going – New Initiatives

New NCCCP Sites—Raising the Bar

• Implement caBIG®

• Collect biospecimens according to NCI Best Practices for Biospecimen Resources

• Electronic health records in place• Increased baseline clinical trials accrual

requirement and must be active in NCI-sponsored trials

• Race and ethnicity tracking by OMB guidelines across all areas

Program Expectations are Increasing (some examples)

Current Expectations(deliverables)

Current Success(exceeding deliverables)

Next Generation Program(new baseline)

Assess caBIG® implementation

12 sites implementing a component of caBIG® in 2010

Required implementation of caBIG® with data sharing capability

Assess NCI Best Practices for Biospecimens

8 sites submitting tissue to TCGA or Moffitt TCC

16 sites → new formalin fixation guidelines

Progress in implementing NCI Best Practices required

No requirement to track OMB race and ethnicity

9 sites tracking OMB race and ethnicity (Note: CHI to all 70 hospitals)

OMB race and ethnicity tracking required

Increase evidence based cancer care

16 sites participating in CoC RQRS NCCCP Quality initiative (e.g. RQRS) required

25 Clinical Trial accruals/yr

NCCCP Electronic accrual log project

At least 8 NCI active trial accruals required + 25

18 ARRA Projects for Current Sites

• Projects span all NCCCP Components • Disparities, Clinical Trials, Quality of Care,

Survivorship & Palliative Care, Biospecimens, Communications, and IT

• Includes New Partnership Opportunities• CTEP’s Early Drug Development Program • CRCHD’s Community Networks Program• DCCPS, CTEP and DCP’s PRO-CTCAE

• MSKCC partnership to pilot electronic patient-reported outcomes for adverse events (PRO-CTCAE) in a community setting

NCCCP Utilizing Imaging Tools

• Dr. Carl Jaffe challenged the NCCCP sites• 3 sites signed on for the electronic data exchange in

clinical research project• 2 of the 3 sites have NBIA installed and nodes open on the

grid• 1 site is doing it a bit differently• Clinical Trial selection coming this summer!

Q & A

Q&A