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 David Huang, MD Co-Principal Investigator Nicole Harada, CCRC Clinical Research Coordinator

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

Cancer Disparities Research Partnership (CDRP) Program RTOG Toronto, Canada Program Update June 2006

Status of Clinical Trials 7 Trials Open 7 Trials Open 5 NCI Sponsored Trials 5 NCI Sponsored Trials 1 NCIC Sponsored Trial 1 NCIC Sponsored Trial 1 Community-Based Trial 1 Community-Based Trial

Trials Open Name of Trial Name of Sponsor Prostate Patient Profiles Project (P 4 ) Louis Warschaw Prostate Cancer Cedars Sinai RTOG 0413 National Cancer Institute RTOG 0232 National Cancer Institute RTOG 0321 National Cancer Institute NCIC CTG MA.20 National Cancer Institute of Canada RTOG National Cancer Institute RTOG 0315 National Cancer Institute

Trials Pending Approval by WIRB Cancer Post Treatment Survey – Exemption Cancer Post Treatment Survey – Exemption Rand/ULAAC Patient Navigator Survey – In progress Rand/ULAAC Patient Navigator Survey – In progress RTOG 0123 – In progress RTOG 0123 – In progress RTOG 0214 – In progress RTOG 0214 – In progress RTOG 0116 – In progress RTOG 0116 – In progress S0424 – In progress S0424 – In progress

Trials Accrued

Accrual to Trial by Ethnicity

Accrual to Trial by Gender

Accrual to Trial by Residence Los Angeles (90008 – 90047)Inglewood (90301 – 90305) Gardena (90249) Torrance (90250)Culver City (90230) Marina Del Rey (90292) Sun City (92586)

Clinical Trials – NCI & Device Sponsored

Reasons for declining clinical trial

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” “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 resubmitted Manuscript resubmitted “National Leadership Summit on Eliminating Racial Disparities in Health” “National Leadership Summit on Eliminating Racial Disparities in Health” January 9-11, 2006, Washington, D.C. January 9-11, 2006, Washington, D.C. “Prophylactic Post-Operative Antibiotics for Prostate Brachytherapy” “Prophylactic Post-Operative Antibiotics for Prostate Brachytherapy” Presented at the 2006 ASCO Prostate Cancer Symposium Presented at the 2006 ASCO Prostate Cancer Symposium

Publications and Presentations “Developing a Lay Patient Navigator Program Addressing Barriers to Care and Participation in Clinical Trials” “Developing a Lay Patient Navigator Program Addressing Barriers to Care and Participation in Clinical Trials” Presented at the REACH 2010 Conference, May 17, 2006 Presented at the REACH 2010 Conference, May 17, 2006 “Preliminary Results and Evaluation of MammoSite® Balloon Brachytherapy for Partial Breast Irradiation for Pure Ductal Carcinoma in Situ: A Phase II Clinical Study ” “Preliminary Results and Evaluation of MammoSite® Balloon Brachytherapy for Partial Breast Irradiation for Pure Ductal Carcinoma in Situ: A Phase II Clinical Study ” Presented at the American Society of Breast Surgeons Meeting, April 2006 Presented at the American Society of Breast Surgeons Meeting, April 2006 “Using Telesynergy® to Improve Access to Clinical Trials at an Underserved Community Based Hospital” “Using Telesynergy® to Improve Access to Clinical Trials at an Underserved Community Based Hospital” Submitted to ASTRO, November 2006 Submitted to ASTRO, November 2006

Publications and Presentations A Lay Patient Navigator Program as Part of a Clinical Trials Infrastructure in a Community Hospital Serving Minority and Low Income Patients A Lay Patient Navigator Program as Part of a Clinical Trials Infrastructure in a Community Hospital Serving Minority and Low Income Patients Submitted to Cancer Health Disparities Summit 2006, Bethesda, MD, Submitted to Cancer Health Disparities Summit 2006, Bethesda, MD, July 17-19, 2006 July 17-19, 2006 The Use of Lay Patient Navigators to Improve Quality of Care and Accrual to Clinical Trials for Radiation Oncology Patients Who Are Minorities or of Low Socioeconomic Status The Use of Lay Patient Navigators to Improve Quality of Care and Accrual to Clinical Trials for Radiation Oncology Patients Who Are Minorities or of Low Socioeconomic Status Accepted for oral presentation at ASTRO 2006, Philadelphia, PA, Accepted for oral presentation at ASTRO 2006, Philadelphia, PA, Nov. 5-9, 2006 Nov. 5-9, 2006 The Urban Latino African American Cancer (ULAAC) Disparities Project: Implementing the NCI-Radiation Research Program Model The Urban Latino African American Cancer (ULAAC) Disparities Project: Implementing the NCI-Radiation Research Program Model Cancer in African Americans - Challenges and Opportunities the Cleveland Clinic Taussig Cancer Center, May 11-13, 2006 Cancer in African Americans - Challenges and Opportunities the Cleveland Clinic Taussig Cancer Center, May 11-13, 2006

Update on Partnership Relations Centinela Freeman Centinela Freeman USC USC UCSF UCSF RAND RAND

USC/Norris Cancer Comprehensive Center Mentoring Institution Mentoring Institution Guidance and oversight in clinical trial infrastructure Guidance and oversight in clinical trial infrastructure Collaboration of clinical trials Collaboration of clinical trials MammoSite DCIS Trial (completed) MammoSite DCIS Trial (completed) P53 Trial ( in development ) P53 Trial ( in development ) High Risk Prostate Cancer ( in development ) High Risk Prostate Cancer ( in development ) Collaboration of tumor boards and case conferences Collaboration of tumor boards and case conferences Weekly combined tumor boards Weekly combined tumor boards

Cancer Disparities Research Partnership (CDRP) Program RTOG Toronto, Canada Process Evaluation: Overview RAND Corporation

Overview of RAND Activities Navigator focus groups Navigator focus groups Development of patient surveys and interview protocols Development of patient surveys and interview protocols Fostering research opportunities Fostering research opportunities (e.g. ACTION) (e.g. ACTION) Assistance on manuscripts Assistance on manuscripts Provider and staff interviews Provider and staff interviews

Process Evaluation Assess whether the project’s goals and objectives have been operationalized and implemented as intended. Assess whether the project’s goals and objectives have been operationalized and implemented as intended. Identify areas where adjustments are needed to increase the program’s effectiveness and efficiency. Identify areas where adjustments are needed to increase the program’s effectiveness and efficiency.

Process Evaluation: Methods and Stakeholders Focus Groups Focus Groups Patient Navigators Patient Navigators Face to Face Interviews Face to Face Interviews Patients Patients Semi-Structured Interviews Semi-Structured Interviews Community Providers Community Providers DFMH/ULAAC Staff DFMH/ULAAC Staff

Focus Group Sessions: Content Areas Patient Navigator Patient Navigator Role Role Motivation Motivation Skills Skills Needs Needs Patient Patient Navigator Training Navigator Training Clinical Trials Clinical Trials Perceptions Perceptions

Patient Instrument: Key Domains Patient Needs and Barriers Patient Needs and Barriers Perceived Satisfaction Perceived Satisfaction Navigator Support Navigator Support Provider Care Provider Care Self-Efficacy Self-Efficacy Cancer knowledge Cancer knowledge Empowerment Empowerment

Update on Telesynergy/Telemedicine Tumor Boards Tumor Boards USC – Every Monday USC – Every Monday CFHS – Every Wednesday CFHS – Every Wednesday Training Sessions Training Sessions ULAAC Navigator Training Programs ULAAC Navigator Training Programs Meetings Meetings Investigator Meeting – Quarterly Investigator Meeting – Quarterly Medical Advisory Board – Quarterly Medical Advisory Board – Quarterly ULAAC – Every Wednesday ULAAC – Every Wednesday Increased participation with mentoring institutions Increased participation with mentoring institutions Increased participation with CDRP sites Increased participation with CDRP sites Clinical Trials Clinical Trials Collaboration with other CDRP sites Collaboration with other CDRP sites Patient consent (Speaking) Patient consent (Speaking) Abstract submitted to ASTRO Abstract submitted to ASTRO

Cancer Disparities Research Partnership (CDRP) Program RTOG Toronto, Canada Patient Navigator Program

Training Program

Active Navigators

Ethnicity of Active Navigators

Navigators Who Are Cancer Survivors

Patient Navigation Data 67% accepted navigation

Ethnicity of Patients Approached Percentage Breakdown: 71% African Americans, 13% Latinos, 11% Caucasians, 4% Asians, 1% Other

Ethnicity of Patients Accepting Navigation Percentage Breakdown: 67% African Americans, 71% Latinos, 55% Caucasians, 70% Asians, 33% Other

Ethnicity of Patients Declining Navigation

Reasons for Declining Navigation

6 Most Common Barriers

Solutions for Barriers Transportation Transportation Taxi vouchers Taxi vouchers Variety of van services to accommodate patients with special needs Variety of van services to accommodate patients with special needs Work with patients’ insurance carrier to provide transportation Work with patients’ insurance carrier to provide transportation Navigators who are willing to drive patients to and from treatment Navigators who are willing to drive patients to and from treatment Psychosocial Psychosocial Match patients with navigators who are cancer survivors (matching type of cancer when possible) Match patients with navigators who are cancer survivors (matching type of cancer when possible) Increase frequency of comfort calls Increase frequency of comfort calls Referral to patient/family support groups and/or counseling Referral to patient/family support groups and/or counseling Financial Financial Financial assistance organizations Financial assistance organizations Food vouchers Food vouchers Salvation Army and Catholic Charities Salvation Army and Catholic Charities Utilities assistance Utilities assistance Housing assistance and referral Housing assistance and referral

Solutions for Barriers Fear of Cancer Fear of Cancer Provide linguistically appropriate, cancer-specific educational materials Provide linguistically appropriate, cancer-specific educational materials Accompany patients to cancer-related medical visits Accompany patients to cancer-related medical visits Encourage support group participation Encourage support group participation Caregiver Caregiver Referral to In Home Supportive Services Referral to In Home Supportive Services Referral to Multipurpose Senior Services Program Referral to Multipurpose Senior Services Program Referral to Comfort Keepers Referral to Comfort Keepers Language Language Assign navigators who are culturally and linguistically appropriate Assign navigators who are culturally and linguistically appropriate Make sure translator is available at patients’ appointments Make sure translator is available at patients’ appointments ALAS Para tu Salud – a translation program based in Los Angeles, CA ALAS Para tu Salud – a translation program based in Los Angeles, CA

Cancer Post-Treatment Survey Cancer Post-Treatment Survey Study Questions: 1. Are there quantitative differences between patients who received navigation versus those who did not in various QOL domains? 2. Are there patient perceived quality differences in the two groups?

Cancer Post-Treatment Survey Cancer Post-Treatment Survey Source: RTOG A-5 Demographic Survey FACIT and Model Questions Domains Evaluated SpiritualSocial/FamilyPhysicalEmotionalFunctional Patient Centered Questions Relationship Based Questions

Cancer Disparities Research Partnership (CDRP) Program RTOG Toronto, Canada Milestonesand Lessons Learned

ULAAC Access Database

ULAAC Access Database –Cancer Post Treatment Survey

Quality Assurance Patient Evaluation of Navigator Services Structured Interview

Centinela Freeman Community Foundation Established Community Health Foundation Established Community Health Foundation Mission: Establish Infrastructure to Support Access to Care and Clinical Research in the Community Mission: Establish Infrastructure to Support Access to Care and Clinical Research in the Community Current Activities Current Activities Recruited Executive Director Recruited Executive Director Diabetes Screening and Care/Navigator Program Diabetes Screening and Care/Navigator Program High School Sports Trainer Funding High School Sports Trainer Funding Centinela Freeman Research Institute Centinela Freeman Research Institute Nursing Academy Nursing Academy Trains 72 RNs per year Trains 72 RNs per year

MSW Intern’s Role Provided navigation Provided navigation Conducted various in-services for navigators (basic training/orientation, self disclosure guidelines) Conducted various in-services for navigators (basic training/orientation, self disclosure guidelines) Developed prototype Patient Tracking Notebook Developed prototype Patient Tracking Notebook Built resource guide for navigators Built resource guide for navigators Laid groundwork for Latino Cancer Support Group Laid groundwork for Latino Cancer Support Group Spanish Spanish

Lessons Learned It takes 15 months to start navigating patients It takes 15 months to start navigating patients It takes at least 1 year to gather enough data for analysis of navigation It takes at least 1 year to gather enough data for analysis of navigation It takes 18 months to start clinical trials It takes 18 months to start clinical trials Clinical trials applicable to our institution and patient population are not plentiful Clinical trials applicable to our institution and patient population are not plentiful Community hospital infrastructure was not initially conducive to grant support…we had to create our own Community hospital infrastructure was not initially conducive to grant support…we had to create our own