National Cancer Institute Research Agenda

1
National Cancer InstituteResearch Agenda

• New Opportunities in Health Services and
  Outcomes Research
• Steven B. Clauser, Ph.D.
• Nancy Breen, Ph.D.
• Applied Research Program
• http//appliedresearch.cancer.gov/
• Academy Health Annual Meeting
• San Diego June 9, 2004

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Session Outline

• Who We Are and What We Do
• New Initiatives in Health Services Research
• Improving Quality of Cancer Care
• Monitoring Cancer Services Data and Methods
• Funding Opportunities for Junior and Mid-level
  Investigators

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Division of Cancer Control and Population Sciences
Office of the Director Dr. Robert Croyle,
Director Dr. Jon F. Kerner, Deputy Director for
Research Dissemination Diffusion
Office OfCancer Survivorship Dr. Julia H. Rowland
Surveillance Research Program Dr. Brenda K.
Edwards
Epidemiology andGenetics ResearchProgram Dr.
Edward Trapido
Behavioral Research Program Dr. Scott Leischow,
Acting
Applied Research Program Dr. Rachel
Ballard-Barbash
Applied CancerScreening Research Dr. Helen
Meissner
Health Services and Economics Dr. Martin Brown
Cancer Statistics Dr. Benjamin Hankey
Analytic EpidemiologyResearch Dr. Sandra Melnick
Basic BiobehavioralResearch Dr. Michael Stefanek
OutcomesResearch Dr. Joseph Lipscomb
Statistical Research and Applications Dr. Eric
Feuer
Clinical and Genetic Epidemiology Research Dr.
Deborah M. Winn
Health Communicationand Informatics
Research Dr. Gary L. Kreps
Risk Factor Monitoring and Methods Dr. Susan
Krebs-Smith
Health PromotionResearch Dr. Linda Nebeling
Tobacco ControlResearch Dr. Scott Leischow
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NCIs Role in Cancer Research
Integrate
Discovery
Accelerate
Interdisciplinary Science
Partnerships Collaborations
Development
Translational Research
Ensure
Delivery
Application in the Clinic Public Health Programs
5
Health Services Research is Relevant Across the
Cancer Continuum
Treatment
Survivorship
Diagnosis
Prevention
Detection

• End-of-Life Care
• Use of Evidence-
• Based Therapies
• Pain Management

• Follow-up of cancer survivors

• Risk Assessment (Cancer genetics)
• Timely Diagnosis and Referral

• Obesity diagnosis and management
• Risk Assessment Communication/
• Counseling
• Cancer chemo- prevention

• Cancer Screening Recommenda-tions and Practices

• Cross Cutting Topics
• Barriers to Care
• Health Disparities
• Continuity of Care
• Quality of Care

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A New NCI Priority to Addressa Major Public
Health Concern
Improving the Quality of Cancer Care
7
Emerging Consensus from Cancer Research and
Policy Communities

• Far too many of the over 9 million cancer
  patients and survivors in the U.S. do not receive
  high-quality care.
• In many instances, no consensus on what
  constitutes quality care -- especially from the
  patients perspective.
• Even where consensus appears to exist, wide
  variations in practice patterns indicate
  significant populations disparities in receipt of
  quality care.
• Presidents Cancer Panel will focus on
  Translating Research into Clinical Practice in
  2004-5 meetings.

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NCIs Response..

• Designate Improving the Quality of Cancer Care
  as a priority area in the 2002, 2003, 2004, and
  2005 Bypass Budget
• The Nations Investment in Cancer Research
  (http//plan.cancer.gov)
• Goal Improve the quality of cancer care by
  strengthening the scientific basis for public and
  private decision making on care delivery,
  coverage, purchasing, regulation, and standards
  setting.

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Defining Quality Cancer Care

• Quality of Care is the degree to which health
  services for individuals and populations increase
  the likelihood of desired health outcomes and are
  consistent with current professional knowledge.
  (Institute of Medicine, 1990)
• In the NCI Initiative, this means
• provision of evidence-based care across the
  cancer continuum
• in a timely and technically competent manner
• with good communication
• shared decision making
• cultural sensitivity

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Cancer Care Quality Improvement Cycle
Identifying Interventions that Improve Outcomes
Strengthening Science Base for Quality of Care
Measuring Outcomes that Matter
Impacting the Delivery of Care
Monitoring Progress and Identifying New Targets
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Cancer Care Quality Improvement Cycle
Identifying Interventions that Improve Outcomes
Strengthening Science Base for Quality of Care
Measuring Outcomes that Matter
Impacting the Delivery of Care
Monitoring Progress and Identifying New Targets
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To Evaluate the State of the Science in Measuring
Outcomes that Matter, NCI established the

• Cancer Outcomes Measurement Working Group
• 35 internationally recognized experts, convened
  in 2001, drawn from academia, government, and
  industry
• Not a consensus panel or advisory committee
• Rather, members analyzed literature, interacted,
  and made recommendations, individually, to NCI
• Focused on patient-reported outcomes
• Findings forthcoming in Outcomes Assessment in
  Cancer (Cambridge University Press, 2004)

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Cancer Outcomes Measurement Working Group Focus
on Patient-Reported Outcomes
HRQOL Satisfaction/Needs Economic Burden

Prevention Screening Treatment Survivorship End
of Life
Breast Prostate Lung Colorectal
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Next Steps Post-COMWG

• Key Research Gaps
• Value-added of patient-reported outcomes (like
  HRQOL) beyond traditional biomedical endpoints?
• Defining the concept of a clinically meaningful
  difference
• Successfully negotiating balance between adequate
  responsiveness for the outcome under study while
  promoting comparability across studies

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Cancer Care Quality Improvement Cycle
Identifying Interventions that Improve Outcomes
Strengthening Science Base for Quality of Care
Measuring Outcomes that Matter
Impacting the Delivery of Care
Monitoring Progress and Identifying New Targets
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• CanCORS

Cancer Care Outcomes Research and Surveillance
Consortium A 5-year, 34M RFA-supported
cooperative agreement to

• study the impact of targeted interventions on
  patient-centered outcomes
• investigate dissemination of state-of-the-art
  therapies in the community
• examine gaps between best, evidence-based
  clinical practice and actual care in community
• analyze disparities in quality cancer care

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CanCORS Study Design

• Established in 2001 co-funded by NCI and VA
• Large observational cohort study of newly
  identified lung and colorectal cancer patients
• For lung 5 research teams with N 4,700
• For colorectal 6 research teams with N 5,300
• Socio-economically,geographically, and
  race/ethnically diverse samples
• Public-private provider mix large HMOs,
  fee-for-service, VA medical centers

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CanCORS Study Design (cont)

• Rapid case ascertainment lt 3 months after
  diagnosis
• Follow-up patients 12 months after diagnosis
• For each patient, creates a longitudinal profile
  of cancer care by utilization multiple data
  sources
• Investigate structure - process - outcome links
  at the patient, provider, and organizational
  level

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CanCORS Specific Aims

• To determine how the characteristics beliefs of
  cancer patients and providers and the
  characteristics of health-care organizations
  influence treatments and outcomes, spanning
  continuum of cancer care from diagnosis to
  recovery or death
• To evaluate effects of select processes of care
  on patients survival, health-related quality of
  life, and satisfaction with care

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Some CanCORS High-Priority Questions

• How and why do processes and outcomes of care
  vary by patient age, race, ethnicity, SES?
• Why do high-volume hospitals tend to have lower
  surgical mortality rates?
• How do patients and physicians go about making
  treatment decisions for metastatic cancer?
• Are symptoms (especially pain and depression)
  treated effectively?

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Cancer Care Quality Improvement Cycle
Identifying Interventions that Improve Outcomes
Strengthening Science Base for Quality of Care
Measuring Outcomes that Matter
Impacting the Delivery of Care
Monitoring Progress and Identifying New Targets
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The Cancer Care Quality Measures Project
(CanQual)

• In 2002, NCI spearheaded the creation of a
  public-private effort
• Convened by the non-profit National Quality Forum
  (NQF)
• Driving Questions
• Where are the most critical quality gaps?
• How can we measure and close those gaps?
• How do we make these measures suitable to support
  QOC improvement strategies?

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The Cancer Care Quality Measures Project
(CanQual)

• Guided by a Steering Committee whose members
  (voting and liaison) are drawn from across the
  spectrum of organizations concerned with the
  quality of cancer care and performance
  measurement, including

ACoS
NCQA
JCAHO
ONS
NCCN
CDC
ACS
AHRQ
NQF
ASCO
ACR
OPM
AAHP- HIAA
NCI
NCCS
NCPB
VA
CMS
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Focus Areas Identified by Steering Committee at
Sept 2002 Meeting (Phase I completed)

• Tumor-site specific measures
• Breast cancer diagnosis and treatment
• Colorectal cancer diagnosis and treatment
• Prostate cancer diagnosis and treatment
• Cross-cutting measures
• Access to care, including clinical trials
• Communications and coordination of care
  (including IT uses)
• Prevention/Screening (including quality of
  screening, risk assessment, and prevention
  activities under purview of health systems)
• Symptom management and end-of-life care

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CanQual Project Plan for Phase II
(2004-2006)
NQF Member Councils NQF Board
Steering Committee (AHRQ, CMS, CDC, NCI as
liaison members)
Data and Methods Panel
4,5
Technical Panel 1 (e.g., colorectal cancer
diagnosis and treatment)
Technical Panel 2 (e.g., breast cancer diagnosis
and treatment)
Technical Panel 3 (e.g., palliative and
end-of-life care)
Evidence-Based Review
Evidence-Based Review
Evidence-Based Review
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Selecting Measures/Research Priorities CanQual
Phase II Timeline Highlights

• Contract Start date May 3, 2004
• Steering Committee selects topics July 2004
• Data and Methods Panel selected and convened
  August 2004
• 3 Technical Panels selected and convened Sept.
  - Oct. 2004
• Technical Panels deliver recommendations on
  core June 2005 -
• measures and future research priorities to SC
  Nov. 2005
• Steering Committee deliver recommendations
  to Sept. 2005 -
• NQF Consensus Development Process Feb.
  2006
• NQF 4 Member Councils, membership and Board
  Sept. 2005 -
• of Directors review and vote on measures
  July 2006
• NQF publishes core measures of cancer care
  Sept. 2006
• quality as voluntary consensus standards

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Phase III and Beyond...

• Continue to build the evidence-base for cancer
  quality of care measurement
• Pilot test endorsed QOC measures
• Develop new measures with public private
  partners
• Work with partners to adopt QOC measures and
  evaluate their dissemination and use
• Work with provider and quality improvement
  organizations to implement QOC-enhancing
  interventions
• Track improvements in QOC -- and feed back
  findings to policy makers at all levels

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Cancer Care Quality Improvement Cycle
Identifying Interventions that Improve Outcomes
Strengthening Science Base for Quality of Care
Measuring Outcomes that Matter
Impacting the Delivery of Care
Monitoring Progress and Identifying New Targets
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Building a National Cancer Data System

• Overall strategy for developing a national system
  to track quality, access and costs of cancer care
  services
• Data Networks
• Data Resources

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Key Steps Toward Building Capacity

• Encourage innovative use of existing data sources
• Registries (e.g., SEER, NPCR, NCDB)
• Medical records
• Administrative files (e.g., Medicare, Medicaid,
  private payers)
• Surveys (e.g., NHIS, CHIS)
• Accelerate development and linkage of multiple
  data sources to
• Enhance timeliness, scope, and level of detail in
  monitoring population
• Capture complexity of cancer care to facilitate
  advanced statistical modeling of
  structure-process-outcome relationships

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Health Services Research Networks

• National, multi-site research networks that
• Can enroll large cohorts of individuals
• Track receipt of cancer control services
  longitudinally at the patient, provider, and
  health system levels
• Investigate impact of interventions on
  patient-centered outcomes
• Current Examples
• Breast Cancer Surveillance Consortium (BCSC)
• Cancer Care Outcomes Research and Surveillance
  Consortium (CanCORS)
• Cancer Research Network (CRN)

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Cancer Research Network

• Initiated in 1999 to create a population research
  laboratory in the context of health care delivery
  systems
• Research on cancer prevention, early detection,
  treatment, and post treatment surveillance
• Collaborative cancer research among health care
  provider organizations oriented to community care
• Access to large, stable and diverse populations
• Existing integrated data-bases that can provide
  patient level information

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Cancer Research Network Sites
GHC Ctr for Health Studies - Lead Site
HealthPartners Research Foundation
Harvard Pilgrim Health Care
Henry Ford Health System
KPNW Ctr for Health Research
KP-Center for Clinical Research
KPNC Division of Research
Meyers Primary Care Institute
KPSC Research Evaluation
KPH Ctr for Health Research, Honolulu
KP Kaiser Permanente
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gt
CRN Population Research Laboratory
Data Resources
Coordinating
CRN
Participating
Project DETECT
Tumor Registry
Center
Plan Policy
Enrollment
Plan Leaders
Plans
Meta
-
data
Surveys
Providers
Hospitalization
Plan
GHC
Surveys
Ambulatory visits
HIT Study
HPHC
level
Long
-
term care
Plan Leaders
HMO Structure
HPRF
data
Providers
Diagnostic Imaging
HFHS
BARRIERS
Pharmacy
KPH
IRB
Providers
KPNC
specific
Demographics
CRN Project
-
KPNW
Enrollment
Administrative
KPRM
Claims
Systems
Cancer Registry
KPSC
Costing Methods
Linked on
MEYERS
Person
Health plan
-
based
Death Files
Medical
level
Member surveys
Record
Pharmacy
Medical
data
Laboratory
Chart Reviews
8.7 million
Systems
Radiology
covered lives
Population
-
based
Pathology
Hospice
(e.g., HEDIS)
Hospitalization
gt3 U.S. Population
Home Health
Ambulatory Care
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CRN Projects

• Core
• Tobacco Cessation Project HIT (HMOs
  Investigating Tobacco)
• Breast and Cervical Cancer Screening Project
  DETECT (Diagnosing Early Tumors Eases Cancer
  Treatment)
• Outcomes of Prophylactic Mastectomy and Early
  Screening in High Risk Women Project
  PROTECTS(Program Testing Early Cancer Treatment
  and Screening)
• Others CanCORS, IMPACT, Pilot Study of
  Disenrollment among HMO Patients with Cancer

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Health Services Research at NCIResearch
Resources

• National Surveys
• National Health Interview Survey Cancer Control
  Topical Module, 1987, 1992, 2000
• California Health Interview Survey, 2000
• National Survey of Mammography Facilities, 1992
• National Survey of Colorectal Screening in
  Healthcare Organizations, 2000
• National Survey of Cancer Genetic Screening, 2000
• Database Resources
• SEER Medicare Linked Database
• Cancer Research Network

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Recent Use of Cancer Screening Tests¹, Initiation
of Medicare Coverage², and USPSTF guidelines³
1987, 1992, 1998, 2000

• PAP smear
• Within the last 3 years, age 25
• Mammogram
• Within the last 2 years, age 40
• FOBT
• Fecal Occult Blood Test within the last year, age
  50
• CRE
• Colorectal endoscopy within the last 3 years, age
  50
• PSA
• Prostate Specific Antigen test within the past
  year, age 50

USPSTF guidelines Initiation of Medicare coverage
Percentages are standardized to the 2000
Projected U.S. Population by 5-year age groups.
1 National Health Interview Survey 2
http//healthservices.cancer.gov/seermedicare/cons
iderations/testing.html 3 U.S. Preventive
Services Task Force. Guide to clinical preventive
services an assessment of the effectiveness of
169 interventions. Baltimore Williams
Wilkins, 1989 for mammography and Pap test
recommendations. U.S. Preventive Services Task
Force. Guide to clinical preventive services, 2nd
ed. Washington, DC Office of Disease
Prevention and Health Promotion, U.S. Government
Printing Office, 1996 for FOBT and CRE.
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CHIS and National Health Interview Survey (NHIS)
Size of Samples
CHIS 2001
NHIS 2000


















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California Health Interview Survey (CHIS)
Designed to Inform Local Health Actions
Department of Health Services
Public Health Institute California
Endowment
Sollicited data and health needs from
communities, tribes, and health departments
NCI CDC IHS
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Content of Cancer Module (2000)
NHIS
CHIS

• Screening
• Use and follow up
• Risk Factors
• Diet nutrition
• Vitamin supplements
• Fruit vegetable consumption
• Physical Activity
• Smoking
• Family History of Cancer
• Genetic screening

X X X X X X X X X X
X X X X X X X
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What are the SEER - Medicare data?

• The SEER-Medicare data are the result of the
  linkage of two large population-based sources of
  data SEER cancer registry data and Medicare
  claims from CMS
• Medicare data are longitudinal, with claims for
  all covered health services from the time of
  eligibility to death. Claims come from all types
  of providers, e.g. hospitals, physicians,
  outpatient clinics, hospice, etc.
• Medicare data are also available for a 5 random
  sample of persons residing in the SEER areas who
  have not been diagnosed with cancer. These files
  can be used to create comparison groups as well
  as population-based rates of testing and
  treatment.

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HSR Funding Opportunities at NCl
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NCI Funding Mechanisms for Junior and Mid-level
Investigators

• K-Awards NCI Training Awards
• R03 Small Research Grants
• R21 Exploratory/Developmental Grants
• R01 Research Projects
• http//deainfo.nci.nih.gov/flash/awards.htm

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Review Process for a Research Grant
National Institutes of Health
Center for Scientific Review
Assign to IC IRG (Study Section)
Study Section
InitiateResearch Idea
Submit Application
Review for Scientific Merit
Institute
Evaluate for Relevance
Advisory Councils and Boards
Allocate Funds
Recommend Action
Institute Director
Takes Final Action
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Minority Investigator Career Development
Workshophttp//www.scgcorp.com/micdw2004/

• In response to the concern that racial and ethnic
  minority researchers have been historically
  underrepresented among NIH funded investigators,
  the NCI is sponsoring a workshop to provide
  training to mid-career and/or transitioning
  investigators from underrepresented racial/ethnic
  groups to enhance their ability to compete for
  NIH funding by providing information that will
  facilitate professional growth and development
  and increase technical skills.
• The workshop will be in Palm Desert, CA July
  21-July 23, 2004.
• Travel support will be provided to a limited
  number of participants.
• Contact Vickie L. Shavers, PhD
• email shaversv_at_mail.nih.gov

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Support for Extramural Investigators Who Want to
Use the SEER-Medicare Data

• NCI offers technical support for data users
  through
• Extensive SEER-Medicare WEB page
• http//healthservices.cancer.gov/seermedicare/
• Data users conferences
• Medical Care supplement
• Special projects related to methods development
• There are 2 (PAs) that are support SEER-Medicare
  projects
• Economic Studies In Cancer Prevention, Screening
  And Care (PA-02-006)
• Cancer Surveillance Using Health Claims-Based
  Data System (PA-02-005)

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PAR 04-036 Colorectal Cancer Screening in
Primary Care Practice

• Utilization of CRC screening in the general
  population is low.
• CRC screening delivery by primary care
  physicians is less than optimal.
• Few U.S. health plans have systems in place for
  CRC screening recruitment and/or results
  tracking.
• Carrie Klabunde, Ph.D.
• E-mail ck97b_at_nih.gov
• Phone [phone]

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Types of Studies PAR 04-036 is Intended to Promote

• Delivery
• Novel ways of integrating CRC screening into
  primary care practice.
• Risk assessment time to completion of tests
  procedure quality.
• Utilization
• Interventions, mechanisms, or systems to improve
  screening compliance.
• Measures, scales, or instruments to assess
  screening adherence over time and with multiple
  modalities.
• Outcomes
• Test performance characteristics and factors
  influencing these in community practice.
• Adverse events.

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For further information on anything presented
today -- including most appropriate NCI contacts,
email.

• Steven Clauser Ph.D., Senior Scientist
• Clausers_at_mail.nih.gov
• Nancy Breen Ph.D., Economist
• Breenn_at_mail.nih.gov
• Applied Research Program