Michael L. Steinberg, MD, FACR Principal Investigator David Khan, MD Co-Principal Investigator

1. Urban Latino African American Cancer (ULAAC) Disparities Project at Centinela Freeman Regional Medical Center Michael L. Steinberg, MD, FACR Principal Investigator David Khan, MD Co-Principal Investigator Nicole Harada Clinical Research Coordinator

2. Our Team • Principal Investigator • Michael Steinberg, MD • Co-Principal Investigators • David Khan, MD, Radiation Oncologist, CF • David Huang, MD, Radiation Oncologist, CF • Nell Forge, PhD, MPH, Assoc. Behavioral Scientist, RAND • Allen Fremont, MD, PhD, Assoc. Natural Scientist, RAND • Oscar Streeter, MD, Radiation Oncologist, USC • Mack Roach, MD, Radiation Oncologist, UCSF

3. Cancer Disparities Research Partnership (CDRP) Program Program Steering CommitteeJanuary 20, 2006Miami, Florida Project Overview

4. Status of Clinical Trials • 12 Trials Open • 10 RTOG Sponsored Trials • 1 Community-Based Trial • 1 Device Trial

5. Trials Open

6. Trials in Development • Melatonin Trial • Glutamine Trial • HDR as Monotherapy

7. Accrual to Clinical Trials

8. Clinical Trial Questionnaire

9. Reasons for Declining Clinical Trials

10. Gender/Ethnicity of Patients of Clinical Trial

11. Publications and Presentations • “Implementing a Lay Patient Navigator Program to Reduce Barriers for Minority Patients Access to Cancer Care and Clinical Trials: Essential Steps and Initial Challenges” Manuscript in review • “OMH National Leadership Summit on Eliminating Racial Disparities in Health January 9-11, 2006 Washington, D.C. Lay Patient Navigator Presentation • “Prophylactic Post-Operative Antibiotics for Prostate Brachytherapy” presentation at the 2006 ASCO Prostate Cancer Symposium at February 2006 • “California Cancer Reach 2010 Conference” May 2006presentation on Patient Navigation

12. Update on Partnership Relations • Centinela Freeman • USC • UCSF • RAND

13. USC/Norris Cancer Comprehensive Center • Mentoring Institution • Guidance and oversight in clinical trial infrastructure • Collaboration of clinical trials • MammoSite Trial • P53 Trial ( in development ) • High Risk Prostate Cancer ( in development ) • Collaboration of tumor boards and case conferences • Weekly Combined Tumor Boards (Telesynergy)

14. USC School of Social Work • Intern Training in Social Service Management of Cancer the Patient and Navigation • Developed Personal Health Record for Patients • Support Group Development • Program Enlarging in 2006/2007

15. University of California, San Francisco • Primary RTOG Site • Guidance and oversight in clinical trial infrastructure

16. Rand Corporation • Providing Evaluation Component of the Program • Program Development Recommendations • Focus Groups with Stakeholders (Community Advisory Board Members, ULAAC Project Staff, Patient Navigators, Community Physicians) • Navigator Focus Groups • ACTION: multi-system collaboration NIH grant

17. Compliance • Clinical • Regulatory • Administrative • Compliance Process • Outside Audit

18. Update on Telesynergy/Telemedicine • Tumor Boards • USC – Every Monday • CFHS – Every Wednesday • Training Sessions • ULAAC Navigator Training Programs • Meetings • Investigator Meeting – Quarterly • Medical Advisory Board – Quarterly • ULAAC – Every Wednesday • Clinical Trials • Collaboration with other CDRP sites • Patient consent

19. Navigator Training Program

20. Navigator Training Outline • The 6-hour training program takes place over three days: • Day One • Brief introduction to the project • The role of the navigator developed by examination of the barriers to health care existing in the community • Vignettes and anecdotes of a typical patient

21. Navigator Training Outline • Day Two • Discussion of the navigator/patient relationship, including initiating contact, offering services and empowering the patient • Recordkeeping is demonstrated at length, with emphasis on the research nature of the project and the importance of adequate charting • Appropriate use of the Intake Form, Hours and Mileage Form, the S.O.A.P. Form, and the Medications List • The biology of cancer and common types of treatment are discussed • Overview of clinical trials presented by one of the co-investigating physicians, including information on the benefits of trials participation to patients and the community

22. Navigator Training Outline • Day Three • Presentation on the Emotional aspects of cancer, sensitizing the trainees to the fears and uncertainties cancer patient may face • Presentation on the Barriers to trials participation in this community are gathered from the participants’ point of view • Discussion about the benefits to trials enrollment are reaffirmed as the trainees learn how to appropriately speak to their assigned patients about participation. • HIPAA presentation on patient confidentiality

23. Navigator Training Three training programs were conducted during the months of March (Group 1), June (Group 2), and September (Group 3), 2005. A total of 39 Navigators were trained.

24. Active Navigators

25. Ethnicity of Active Navigators

26. Navigators Who Are Survivors

27. Patient Navigation Data

28. Reasons for Declining Navigation

29. Patient Navigator Case Load

30. Chart Audit: “Barriers to Care”

31. Barriers to Care: Chart Audit

32. 6 Most Common Barriers

33. Assessment and Effectiveness of Quality Assurance • Navigator Focus Groups (Rand source protected feedback) • Patient Satisfaction Survey, compatibility and does the navigation process meet patient needs (patient perception of effectiveness) • Clinical Trials Questionnaire • Telephone interviews with patients • Compliance interviews (5%)

34. CHALLENGES AND OPPORTUNITIES • Evaluation of effect on trials • Pushing navigation earlier in the process of care (surgeons, primary care, screening) • Using army of navigators in community outreach • Using navigator for disaster preparedness • Testimonial method in training and in presentation of clinical trials

35. CHALLENGES AND OPPORTUNITIES • Ongoing Evaluation Will Provide Practical Information • Elimination of barriers to care • Quality assessment • Effects of navigation on accrual to clinical trials

36. Spawned from the ULAAC Grant • Cancer Committee • ACoS Accreditation with 7 commendations • Tumor Boards case conferences weekly • Community Outreach and health screenings • Navigators outreach educating the community about the benefits of clinical trials • Development of a Spanish Support Group

37. Media Coverage • La Opinion article, November 11, 2005 • To Navigate Services in a Health System: The Patient Navigator Program Helps Sort Through Obstacles that Make it Difficult to Treat Cancer • Inglewood Today article, October 12, 2005 • Taking Care of Business: The Urban Latino African American Cancer (ULAAC) Disparities Project • KCAL 9 news station (CBS)– December 7, 2005 2:00 PM, 3:00 PM, and 4:00 PM news ULAAC: New cancer Program Helps Patients Navigate System http://cbs2.com/video/?id=11126@kcbs.dayport.com

38. Centinela Freeman Community Foundation • Mission Statement: “The mission of the Centinela Freeman Community Foundation is to enhance the health and healthcare of South and Southwest Los Angeles by developing and supporting healthcare education, medical research, and programs which improve access to healthcare for the citizens of our community.”

39. Centinela Freeman Community Foundation • Leveraging Off Previous Community Based Foundations … Formed New Foundation • Establishing Infrastructure to Support Access to Care and Clinical Research in the Community • Current Activities • Recruited Executive Director • Diabetes Screening/Navigator Program • Cancer Screening Program • High School Sports Trainer Funding • Nursing Academy • Low cost insurance supplement collaboration

40. “Still Too Separate, Not Yet Equal”… A. Epstein • Describing And Explaining Disparities Is Much Easier Than Devising Strategies To Reduce Disparities