Cancer Control

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

Community Clinical Oncology Program

CCOPs

Cooperative Groups

Integral to NCI Clinical Trials Network

Cancer Centers

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


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

Intra-CCOP Relations

Component 4

Component 3

Component 2

Component 1

Hospital

Hospital

Hospital

Hospital

CCOP Central Office


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


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

Intra-Research Base RelationsIntra-Research Base Relations

Unit4Unit

3Unit

2

Unit1

Research Base CentralOperations

Office

CancerControl

Committee

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

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

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:

CCOP - Objectives

• Conduct treatment and cancer prevention & control trials in the community

• Improve community practice patterns

• Diffuse state-of-the-art cancer management

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


• 50 CCOPs (31 States)

• 11 MBCCOPs (8 States, DC & Puerto Rico)

• 12 Research Bases


Participating Physicians (4,037)

– 2,505 Physicians Accrue Trial Participants

– 1,532 Physicians Refer Trial Participants

Participating Hospitals (403)


CCOP & MBCCOP

Med Onc/Hem51%

Rad Onc16%

Surgeons13%

Primary Care12%

All Others1%

Urologists7%


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

PracticePatterns

Time

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

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.

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

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?

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

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

What Did We Learn?

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

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

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

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.

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


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


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


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


Accrual to Open Prevention Trials:(Funded by Peer-reviewed Supplements to

Research Base Grants)

• SELECT 18,881 (62%)

• STAR 15,454 (81%)


Impact in Cancer Control:

– All Cooperative Group Symptom Management, Palliative Care Clinical Trials

– Broad Portfolio of Trials Developed and Ongoing


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

Cancer Control

Health & Medicine

Transcript of Cancer Control