Cancer Control

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  • Board of Scientific Advisors
    Overview of CCOPs
    Including brief presentation of Program Successes:
    Meeting its own goals
    Successes/impact in Clinical Research
    Successes/impact in Organizational Studies Research
    My dissertation
    Other research opportunities using CCOPs
  • Cancer Control

    1. 1. Cancer Control & Prevention Research: The Case of CCOP’s Escola Nacional de Saude Publica Sergio Arouca Fundacao Oswaldo Cruz Rio de Janeiro, RJ June 2004 Arnold D. Kaluzny, Ph.D. Professor of Health Policy and Administration
    2. 2. Community Clinical Oncology Program CCOPs Cooperative Groups Integral to NCI Clinical Trials Network Cancer Centers
    3. 3. Community Based Cancer Care: Challenge • 80% care in community • Questionable quality • Treatment, prevention and control • Indeterminate/dynamic technology • Guidelines not effective/CHOP • Changing delivery system
    4. 4. Community Clinical Oncology Program What is a CCOP? – A Group of Community Hospitals and Physicians – Funded by a Peer Reviewed Cooperative Agreement – To Participate In NCI-approved Cancer Treatment, and Cancer Prevention and Control Clinical Trials
    5. 5. Intra-CCOP Relations Component 4 Component 3 Component 2 Component 1 Hospital Hospital Hospital Hospital CCOP Central Office
    6. 6. Community Clinical Oncology Program What is a Minority-Based CCOP (MB-CCOP)? – Hospitals and Physicians with > 40% New Cancer Patients from Minority Populations – University Hospitals are Eligible to Apply – Funded by a Peer-Reviewed Cooperative Agreement – Participate in NCI-approved Cancer Treatment, and Cancer Prevention and Control Clinical Trials
    7. 7. Community Clinical Oncology Program What is a CCOP Research Base? – An NCI-designated Cancer Center or Cooperative Group – Funded by a Peer- Reviewed Cooperative Agreement – Develop and Conduct Cancer Prevention and Control Clinical Trials – Supports Development of Cancer Prevention Science
    8. 8. Intra-Research Base RelationsIntra-Research Base Relations Unit 4Unit 3 Unit 2 Unit 1 Research Base Central Operations Office Cancer Control Committee
    9. 9. Components of the Community Clinical Oncology Program National Cancer Institute _______________________ Overall Direction Program Management Funding Research Bases ________________________ Development of Protocols Data Management and Analysis Quality Assurance CCOPs ____________________ Accrual to Protocols Data Management Quality Control Cancer Patients and Subjects at Risk for Cancer Figure 2.1. Components of the Community Clinical Oncology Program
    10. 10. CCOP - A “Strategic Alliance” A loosely coupled arrangement among existing organizations designed to achieve some long term strategic purpose not possible by any single organization
    11. 11. Community Clinical Oncology Program MISSION • Involving community physicians and their patients in NCI-approved clinical trials • Involving primary health care providers in research process • Increasing minority participation Bring the advantages of state-of-the-art cancer treatment, prevention, and control research to individuals in their own communities by:
    12. 12. CCOP - Objectives • Conduct treatment and cancer prevention & control trials in the community • Improve community practice patterns • Diffuse state-of-the-art cancer management
    13. 13. CCOP - Methods • Increase access to clinical trials • Involve community physicians (including primary care physicians) in clinical research • Establish a clinical network for prevention & control research
    14. 14. Community Clinical Oncology Program • 50 CCOPs (31 States) • 11 MBCCOPs (8 States, DC & Puerto Rico) • 12 Research Bases
    15. 15. Community Clinical Oncology Program Participating Physicians (4,037) – 2,505 Physicians Accrue Trial Participants – 1,532 Physicians Refer Trial Participants Participating Hospitals (403)
    16. 16. Community Clinical Oncology Program CCOP & MBCCOP Med Onc/Hem 51% Rad Onc 16% Surgeons 13% Primary Care 12% All Others 1% Urologists 7%
    17. 17. Community Clinical Oncology Program CCOP Program Funding FY2002 $91.3 Million  CCOPs $32.8 million  MBCCOPs $ 4.6 million  Research Bases $14.1 million  Prevention Members $ 2.9 million  Large Prevention Trials • SELECT $15.8 million • STAR $13.9 million • PCPT $ 7.2 million
    18. 18. Practice Patterns Time
    19. 19. Community Based Cancer Care: LESSONS • No diffusion effect • Change practice patterns - breast • Need “relevant” protocols • Involve support personnel • Uneasy interactions – University/Community – Providers/Social Science
    20. 20. Follow-up Study of Cancer PreventionFollow-up Study of Cancer Prevention and Control Research inand Control Research in CCOPs & CCOP Research BasesCCOPs & CCOP Research Bases Martha M. McKinney, Ph.D. Bryan J. Weiner, Ph.D.
    21. 21. Why This Study? • CCOPs and their research bases have proven their capability to conduct CP/C trials but . . . Little is known about the structural and strategic adaptations that they have made to integrate CP/C research into their operations..over time • Study Objectives: – Assess extent of integration of CP/C research in selected cooperative groups and factors contributing to integration – Assess how CCOPs have adapted their organizational structures and recruitment strategies to accrue participants to CP/C clinical trials
    22. 22. What Did We Want to Learn? How Have CCOP Research Bases … • Defined the scope and priority of CP/C research? • Built internal capacity to design and conduct CP/C research? • Generated investigator interest in designing and conducting CP/C clinical trials? • Budgeted for CP/C research and obtained financial support?
    23. 23. What Did We Want to Learn? How Have CCOPs … • Adapted staffing arrangements to conduct CP/C clinical trials? • Determined which CP/C protocols to activate? • Identified and recruited prevention trial participants? – Outreach to non-oncologists – Outreach to consumers
    24. 24. Methods • Research Design: Case Studies – Four cases: ECOG, SWOG, NCCTG, NSABP – Time Period: October 2002 - August 2003 • Data Sources: – 65 individual interviews (included 12 CCOP PIs and 14 CCOP nurses/CRAs) – Observation of scientific sessions & committee mtgs – Review of grant applications/annual reports
    25. 25. What Did We Learn?
    26. 26. Structural Adaptations • CCOP nurses and CRAs have primary responsibility for CP/C clinical trials • Most CCOPs have nurses/CRAs working solely or primarily on prevention trials • Presence of dedicated staff helps build community linkages • Some CCOPs are reviewing all patient charts to assess eligibility for symptom management studies
    27. 27. Protocol Selection Criteria • CCOPs review new protocols for scientific merit, clinical applicability, and feasibility • Expected return on investment is a major consideration • Types of CP/C protocols most feasible to implement: – Compatible with community demographics and physician practice patterns – Relatively simple to execute – Minimal financial and time costs for clinicians and patients
    28. 28. Outreach to Non-Oncologists • Strategies – Regular visits to present “menus” of protocols – Targeted mailings of study-specific fliers – Assistance in screening patient charts, explaining prevention trials, and/or obtaining informed consent – Continual feedback on study progress and results • Incentives – Appointment as CCOP investigator – Travel support to attend cooperative group meetings – Certificates and “thank you” breakfasts/lunches
    29. 29. Outreach to Consumers Direct-to-consumer marketing through . . . • Print and electronic media – Newspapers and newsletters – Brochures in medical office waiting rooms – Radio and television talk shows & PSAs • Partnerships – Prevention trial participants – Cancer screening programs – Breast & prostate cancer support groups • Community outreach – Health fairs, civic clubs, churches, etc.
    30. 30. Conclusions • CCOPs’ ability to participate in CP/C research depends upon the adequacy of funding for dedicated staff and for participant recruitment/adherence • CCOPs need more opportunities to comment on feasibility issues before CP/C protocols are finalized • Varied types of incentives and technical support are needed to involve non-oncologists in prevention trials
    31. 31. Community Clinical Oncology Program Impact in Prevention: – Over 65,000 Persons at Risk for Cancer on Prevention Clinical Trials – CCOP Network Is the Vehicle to Conduct Phase III Cancer Prevention Trials – Community Physicians Practices Are the Forefront for Cancer Prevention
    32. 32. Community Clinical Oncology Program Research Accomplishments: Prevention  Breast Cancer Prevention Trial-Tamoxifen  Colorectal Adenoma Prevention-Aspirin  Second Primary Prevention-13-cis retinoic Acid  Non-small Cell Lung Cancer  Head and Neck Cancer
    33. 33. Community Clinical Oncology Program Prostate Cancer Prevention Trial with Finasteride (PCPT)  Closed to Accrual: December 1997  N=18,882  Endpoint: End-of-Study Biopsy (EOS)  EOS Proceeding on Target
    34. 34. Community Clinical Oncology Program Accrual to Open Prevention Trials: (Funded by Peer-reviewed Supplements to Research Base Grants) • SELECT 18,881 (62%) • STAR 15,454 (81%)
    35. 35. Community Clinical Oncology Program Impact in Cancer Control: – All Cooperative Group Symptom Management, Palliative Care Clinical Trials – Broad Portfolio of Trials Developed and Ongoing
    36. 36. Community Clinical Oncology Program Impact of CCOP Participation in Treatment:  1/3 Treatment Accrual to CTEP Trials  92,500 Patients on Treatment Clinical Trials  Results from Treatment Trials are Applicable to Patients in Their Communities  Community Physicians Who Participate in Trials More Rapidly Adopt State-of-the-Art Treatment

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