Reaching Out To The Community

1. Reaching Out To The Community To Enhance Accrual Of Special Populations Elizabeth A. Patterson MD FACR October 2, 2008

2. Accrual Of Special Populations • Why should we be concerned? • NIH Revitalization Act in 1993 requirement • Participation in clinical trials is important for elimination of health disparities.

3. National Institutes of Health (NIH) Revitalization Act • NIH clinical research must include ample numbers of minorities, as well as women, in order to allow for in-depth analyses of minority populations. • If trials do not include minorities, then there’s a question of whether or not the results of the studies are relevant to everyone across the board • Whether one can trust and apply the results of a clinical trial, as well as transfer them into clinical practice

4. Cancer Health Disparities • The National Cancer Institute (NCI) definition: adverse differences in cancer incidence, cancer prevalence, cancer mortality, cancer survivorship, and burden of cancer or related health conditions that exist among specific population groups in the United States • These population groups may be characterized by gender, age, ethnicity, education, income, social class, disability, geographic location and sexual orientation.

5. Cancer Death Rates* by Race and Ethnicity US 1999-2003 *Per 100,000, age-adjusted to the 2000 US standard population. † Persons of Hispanic origin may be of any race. Source: Surveillance, Epidemiology, and End Results Program, 1975-2003, Division of Cancer Control and Population Sciences, National Cancer Institute, 2006.

6. Hispanic/Latina Females: Highest Incidence Rates for Cervical Cancer Statistics are for 1998-2002, are adjusted to the 2000 U.S. standard million population, and represent the number of new cases of invasive cancer per year per 100,000 females.

7. For both males and females, incidence of primary liver cancer for Hispanics is about twice as high as for non-Latinos in the same area. Rates of primary liver cancer appear to be particularly high among Mexican Americans in Texas, even when compared to Latinos in California or other regions. Liver Cancer

8. ACRIN 6673Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients

9. Health Disparities • African American men have far higher death rates from prostate cancer than any other racial or ethnic group. • Both incidence and mortality rates from lung cancer are higher among African American men than in Whites, even though they begin smoking at an older age and smoke fewer cigarettes per day. • The Appalachian region has a higher mortality rate for all cancers in the US as a whole.

10. Colon and Rectum Cancer Data ACS Surveillance Branch Research 2007

11. Lung Cancer

12. Composition of Trial EnrolleesAccording to Race/Ethnicity, 1996-2002 Included Breast, Colon-rectal, Lung and Prostate non-surgical cooperative group trials Murthy VH JAMA. 2004;291:2720-2726 Participation in Cancer Clinical Trials Race-, Sex-, and Age-Based Disparities

13. Barriers to Clinical trial Participation Physician Barriers General Population Barriers Specific Barriers Diverse Populations Lack of awareness Doctors may not mention clinical trials as an option Lack of awareness Unwillingness to "lose control" Lack of access Cultural or ethnic values / beliefs Fear, distrust, or suspicions of research Belief that standard therapy is best Language or literacy Administrative burden Personal obstacles Preconceived ideas Belief patient would not Insurance / cost Lack of access

14. Aware of Clinical Trial Interviews with nearly 6,000 patients with a variety of cancers

15. Leave Stereotypes at the Door

16. United States African-American Population http://www.censusscope.org/us/map_nhblack.html

17. United StatesHispanic Population http://www.censusscope.org/us/map_hispanicpop.html

18. United StatesAsian Population http://www.censusscope.org/us/map_nhasian.html

19. Outreach to communities • Racial or ethnic • African Americans/Blacks • Asian Americans • Hispanic/Latinos • American Indians • Alaska Natives • Elderly/disabled • Rural • Uninsured/limited insurance • Poor • Limited access to effective healthcare

20. Enhance Clinical Trials Outreach and Education • Efforts at your institution • Collaborate with health care providers: primary care, internist, oncologist, surgeons • Patient navigators • Other professionals involved in patient care • Efforts in your community • Ongoing education about clinical trials beyond any particular trial • Participate in health fairs • Outreach activities with community groups • Primary care/Community physicians • Community-based organizations.

21. Education and Outreach • Use established referral networks • Communication • Use support groups to facilitate • Enlist Clinical trial participants • Patient Advocates • Establish and maintain key relationships/partnerships • Maintain an ongoing program of community involvement & outreach

22. Promotional materials (TV, Radio, Newspaper, & the Internet) News stories Especially in Local/community papers Use of culturally sensitive Use direct mail (it works) Boise hospitals contribute to medical advances Clinical trials involving patients at Boise hospitals will lead to better treatments BY COLLEEN LAMAY - clamay@idahostatesman.com Edition Date: 08/22/08 A St. Luke's Boise nurse practitioner got her 15 minutes of fame recently when she appeared on national TV to talk about a clinical trial she devised to show women how to reduce the pain of mammograms. Use the Media

23. Disseminate the MessageTo Enhance Clinical Trials Outreach, Education and Recruitment • Be creative • Be flexible • Create opportunities • Think out of the box Community Senior Citizen Center Work Friends Club Meeting Church School Neighbors Family Community Center

24. Recruitment Tips • Know your community • Understand the group you need to target • Identify barriers to the targeted population • Provide cultural and language appropriate informational material