cancer control
DESCRIPTION
TRANSCRIPT
![Page 1: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/1.jpg)
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
![Page 2: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/2.jpg)
Community Clinical Oncology Program
CCOPs
Cooperative Groups
Integral to NCI Clinical Trials Network
Cancer Centers
![Page 3: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/3.jpg)
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
![Page 4: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/4.jpg)
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
![Page 5: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/5.jpg)
Intra-CCOP Relations
Component 4
Component 3
Component 2
Component 1
Hospital
Hospital
Hospital
Hospital
CCOP Central Office
![Page 6: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/6.jpg)
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
![Page 7: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/7.jpg)
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
![Page 8: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/8.jpg)
Intra-Research Base RelationsIntra-Research Base Relations
Unit4Unit
3Unit
2
Unit1
Research Base CentralOperations
Office
CancerControl
Committee
![Page 9: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/9.jpg)
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
![Page 10: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/10.jpg)
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
![Page 11: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/11.jpg)
Community Clinical Oncology ProgramMISSION
• 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:
![Page 12: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/12.jpg)
CCOP - Objectives
• Conduct treatment and cancer prevention & control trials in the community
• Improve community practice patterns
• Diffuse state-of-the-art cancer management
![Page 13: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/13.jpg)
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
![Page 14: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/14.jpg)
Community Clinical Oncology Program
• 50 CCOPs (31 States)
• 11 MBCCOPs (8 States, DC & Puerto Rico)
• 12 Research Bases
![Page 15: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/15.jpg)
Community Clinical Oncology Program
Participating Physicians (4,037)
– 2,505 Physicians Accrue Trial Participants
– 1,532 Physicians Refer Trial Participants
Participating Hospitals (403)
![Page 16: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/16.jpg)
Community Clinical Oncology Program
CCOP & MBCCOP
Med Onc/Hem51%
Rad Onc16%
Surgeons13%
Primary Care12%
All Others1%
Urologists7%
![Page 17: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/17.jpg)
![Page 18: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/18.jpg)
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
![Page 19: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/19.jpg)
PracticePatterns
Time
![Page 20: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/20.jpg)
![Page 21: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/21.jpg)
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
![Page 22: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/22.jpg)
Follow-up Study of Cancer PreventionFollow-up Study of Cancer Preventionand Control Research inand Control Research in
CCOPs & CCOP Research BasesCCOPs & CCOP Research Bases
Martha M. McKinney, Ph.D.
Bryan J. Weiner, Ph.D.
![Page 23: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/23.jpg)
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
![Page 24: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/24.jpg)
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?
![Page 25: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/25.jpg)
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
![Page 26: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/26.jpg)
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
![Page 27: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/27.jpg)
What Did We Learn?
![Page 28: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/28.jpg)
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
![Page 29: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/29.jpg)
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
![Page 30: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/30.jpg)
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
![Page 31: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/31.jpg)
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.
![Page 32: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/32.jpg)
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
![Page 33: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/33.jpg)
![Page 34: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/34.jpg)
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
![Page 35: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/35.jpg)
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
![Page 36: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/36.jpg)
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
![Page 37: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/37.jpg)
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%)
![Page 38: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/38.jpg)
Community Clinical Oncology Program
Impact in Cancer Control:
– All Cooperative Group Symptom Management, Palliative Care Clinical Trials
– Broad Portfolio of Trials Developed and Ongoing
![Page 39: Cancer Control](https://reader033.vdocument.in/reader033/viewer/2022061207/5484a5c0b4af9fbd5d8b4768/html5/thumbnails/39.jpg)
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