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AACR2013Final

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AACR2013Final

  1. 1. Overcoming Cultural and Geographic Barriers to Participation in Clinical Trials Among Native Hawaiians AACR: The Science of Health Care Disparities Jeffrey L Berenberg, MD, FACP University of Hawaii Cancer Center
  2. 2. Disclosure Information • AACR: The Science of Health Care Disparities • Jeffrey L Berenberg • I have no financial relationships to disclose. • I will not discuss off label use and/or investigational use in my presentation
  3. 3. To Be Discussed • Cancer Disparities in Native Hawaiians • Barriers to Clinical Trial Participation • Participation in Clinical Trials • Effective Measures for Enrollment in Clinical Trials • Remaining Challenges
  4. 4. Ethnic Disparities in Prostate Cancer Hawai`i, 2000-2005 Native Hawaiian Native Hawaiian Filipino Filipino Caucasian Caucasian Japanese Japanese Rates are age-adjusted to US 2000 standard.
  5. 5. Ethnic Disparities in Lung Cancer Hawai`i Males, 2000-2005 Native Hawaiian Native Hawaiian Filipino Filipino Caucasian Caucasian Japanese Japanese Rates are age-adjusted to US 2000 standard.
  6. 6. Ethnic Disparities in Colorectal Cancer Hawai`i Males, 2000-2005 Native Hawaiian Native Hawaiian Filipino Filipino Caucasian Caucasian Japanese Japanese Rates are age-adjusted to US 2000 standard.
  7. 7. Ethnic Disparities in Cervical Cancer Hawai`i Females, 2000-2005 Native Hawaiian Native Hawaiian Filipino Filipino Caucasian Caucasian Japanese Japanese Rates are age-adjusted to US 2000 standard.
  8. 8. Breast Cancer in the Multiethnic Cohort Risk Factor-Adjusted Incidence • 1757 incident post menopausal breast cancer cases through 1999 • Seven risk factors: age at menarche + first birth, parity, type menopause, weight, hormone replacement and ethanol consumption Relative Risk for Breast Cancer White Japanese Native Hawaiian Unadjusted RR 1 0.99 1.30 RR adjusted for risk factors 1 1.11 1.65 Pike et al Cancer Epidemiology, Biomarkers & Prevention, Vol 11 September 2002
  9. 9. Ethnicity and Breast Cancer in Hawaii Ethnic Disparities in Survival Persist after Stage Adjustment • 4,078 women diagnosed from 1990-1997 • Followed for 5 years • Differences were seen in age, TMN and ER/PR • 31% Native Hawaiians in the <39 year old group died vs. 12% Japanese • Native Hawaiians had lowest or second lowest survival in stage I, III and IV • Even in ER+PR+: 15% of Native Hawaiian women died vs. 5% of Japanese women Braun et al; Ethnicity and Disease. Vol 15, 2005
  10. 10. Breast and Cervical Cancer Screening Women, Hawai`i, 2007 Ever had Mammogram? (%) Mammogram within Past Year? (% with Mammogram) Ever had Pap Smear? (%) Pap Smear within Past 3 Years? (% with Pap Smear) Native Hawaiian 91.8 76.1 94.5 81.9 Filipino 90.9 74.0 93.6 82.7 Caucasian 93.1 76.0 96.9 83.1 Japanese 94.5 78.6 94.3 81.3 Source: Hawai`i Department of Health, Behavioral Risk Factor Surveillance Survey (BRFSS).
  11. 11. Colorectal Cancer Screening Adults, Aged 50 or Older, Hawai`i, 2007 Ever had Fecal Occult Blood Test (FOBT)? (%) FOBT within Past Year? (% with FOBT) Ever had Sigmoidoscopy / Colonoscopy? (%) Sigmoidoscopy / Colonoscopy within Past Year? (% with scan) Native Hawaiian 47.4 20.4 48.4 22.3 Filipino 41.1 21.6 35.9 18.0 Caucasian 51.8 21.5 63.1 33.0 Japanese 53.6 23.0 66.4 34.5 Source: Hawai`i Department of Health, Behavioral Risk Factor Surveillance Survey (BRFSS).
  12. 12. Prostate Cancer Screening Males, Aged 40 or Older, Hawai`i, 2007 Ever had Digital Rectal Exam (DRE)? (%) DRE within Past Year? (% with DRE) Ever had PSA? (%) PSA within Past Year? (% with PSA) Native Hawaiian 65.2 28.5 46.1 27.6 Filipino 40.9 17.9 35.5 26.2 Caucasian 79.0 37.0 64.7 44.0 Japanese 65.5 33.2 58.2 45.7 Source: Hawai`I Department of Health, Behavioral Risk Factor Surveillance Survey (BRFSS).
  13. 13. Ethnic Disparities in Late Stage Cancer, 2000-2005 Rates are age-adjusted to US 2000 standard.
  14. 14. Ethnic Disparities in Prostate Cancer Hawai`i, 1975-2005
  15. 15. Barriers to Clinical Trials • Access - No trials available on islands of Hawaii, Maui and Molokai • Perceived Cost • Insurance - minor difference for Native Hawaiians • Distance • Limited support • Child care
  16. 16. Barriers to Clinical Trial Participation • Feeling intimidated • Not knowing what to ask • Health care literacy • Referring providers have little knowledge
  17. 17. Barriers to Clinical Trial Participation: MD Survey 2002 • 88 cancer specialists (50% medical oncologists, 33% surgeons) • 47 (53% answered, 50% Caucasian) • MD barriers identified: lack of support staff, preference for standard treatment, time to go over informed consent, lack of compensation • Patient barriers: patient refused, perceived co-morbidities and lack transportation Kaanoi et al; Hawaii Med J. 2002
  18. 18. Barriers to Clinical Trial Participation: MD Survey 2002 • Trials felt to be too time consuming • Not innovative • Not answering questions relevant to my patients Kaanoi et al; Hawaii Med J. 2002
  19. 19. Barriers Cited by Primary Care MDs • 28% of PCPs surveyed in 2003 (n=254) had recommended a cancer prevention trial • PCPs cited more physician-related barriers than cancer specialists. most frequently: lack of support staff (72%) • Perception too much physician time (48%). • Others: – Discomfort with randomized trials (27%) – Feeling that trials are unimportant (21%) . Ka‘ano‘i ME, 2004; et al Pac Health Dialog
  20. 20. Barriers Cited by Primary Care MDs • Patients refused to participate (36%) • Patients have co-morbidities that preclude their participation in CTs (37%) • Lack of transportation (36%) • Lack of insurance (25%) Ka‘ano‘i ME, 2004; et al Pac Health Dialog
  21. 21. Attitudes of Primary Investigators • Survey of 683 NHLBI investigators doing research in 2001. 440 respondents. • 60% failed to complete study enrollment • Many PIs did not set recruitment goals, especially for Native Hawaiians 22% Durant, R. W. et al; Annals Epidemiology 2007
  22. 22. Participation in Clinical Trials, Hawaii • Examined the ethnic-specific participation rates of four closed cancer prevention trials conducted in Hawaii: Breast Cancer Prevention Trial (BCPT) Study of Tamoxifen and Raloxifene (STAR) Prostate Cancer Prevention Trial (PCPT) Selenium and Vitamin E Cancer Prevention Trial (SELECT) • Compared methods of recruitment across prevention trials • Examined the ethnic-specific participation rates in cancer treatment trials conducted in Hawaii, 1992-2004, 2005- 2011
  23. 23. Ethnic-Specific Participation Rates in Cancer Prevention Trials (1992-2004) BCPT (%) STAR (%) PCPT (%) SELECT (%) Native Hawaiian 8.9 11.3 5.6 4.4 Asian 53.1 61.0 44.4 39.1 Caucasian 38.1 26.4 49.2 53.3 Other -- 1.2 0.8 3.3
  24. 24. Differences in Ethnic-Specific Participation Rates in Cancer Prevention Trials by Sex* (1992-2004) *P = 1.0 x 10-4 Females (n=272) Males (n=213) Native Hawaiian 10.3% 5.1% Asian 57.7% 43.2% Caucasian 31.3% 49.8% Other 0.7% 1.9%
  25. 25. Ethnic-Specific Participation Rates in Cancer Treatment Trials (1992-2004) Female cancers primarily: breast, colon, ovarian Male cancers primarily: prostate, colon, lung Females (n=631) Males (n=195) Native Hawaiian 13.3% 8.2% Asian 62.9% 59.0% Caucasian 22.3% 30.3% Other 1.4% 2.6%
  26. 26. Ethnic-Specific Participation Rates in Cancer Treatment Trials (2005-2011) Female cancers primarily: breast, colon, ovarian Male cancers primarily: prostate, colon, lung Females (n=870) Males (n=313) Native Hawaiian 16.9% 7% Asian 55.6% 55% Caucasian 24.1% 36.4% Other 3.4% 1.6%
  27. 27. Recruitment for Prevention Trials STAR (n=161):  77% physician referral/prior BCPT participation  18% by targeted mailing  5% other SELECT (n=98):  7% physician/prior PCPT participation  28% by targeted mailing  26% media  40% not recorded  2% other
  28. 28. Conclusions  Participation of Native Hawaiian women was more proportionate to the population than Native Hawaiian men in both prevention and treatment trials  Prostate and breast cancer prevention trial participants attributed their recruitment to different strategies
  29. 29. What Has Been Effective? University of Hawaii Minority Based Clinical Oncology Program (MBCCOP) • Education and clinical trial promotion to local oncologists in multiple specialties • Provides a network of clinical research associates and nurses to support screening, enrollment, data management and retention • ASCO Clinical Trials Participation Award 2009 • Tailored approach in varied sites • Coupons for Cure (Travel Support 8-10 pts/yr)
  30. 30. What Has Been Effective? University of Hawaii Minority Based Clinical Oncology Program (MBCCOP) • Community Research Advocacy Board prioritizes trials suitable for patients • Formation of consortium for cancer research across participating hospital clinics and practice sites • Availability across Oahu and Kauai
  31. 31. What Has Been Effective? • UHCC organized state wide Clinical Trials Education Committee (CTEC) with goal to increase clinical trials awareness statewide • Establish/strengthen partnerships among agencies/institutions for the purpose of clinical trials • Disseminate resources for clinical trials promotion and education • Membership: 50+ individuals from a variety of organizations
  32. 32. What Has Been Effective? Imi Hale • NCI funded Native Hawaiian Cancer Network • Conducted research into barriers • Cancer navigation program from 2006 to present • Worked with Queens Medical Center to bring EDICT (Eliminating Disparities in Clinical Trials) program to Hawaii – 90 community leaders, survivors, advocates, providers and politicians attended
  33. 33. What Has Been Effective? Imi Hale • Worked with Queens Medical Center and ENACCCT (Education Network to Advance Cancer Clinical Trials) to educate primary care providers on the importance of clinical trials • 128 attendees, Follow-up questionnaire answered by 83 individuals • Plan primary care education by MBCCOP staff in smaller groups of physicians
  34. 34. ENNACT Follow Up Survey • 73% - presentation increased their awareness about myths about cancer clinical trials • 78% - presentation increased their awareness about how to bring up cancer clinical trials in a conversation with their patients • 77% - presentation increased their knowledge on how to influence their patients’ decision to consider participating in a cancer clinical trial • 77% -increased their willingness to mention cancer clinical trials more often to their patients
  35. 35. What Has Been Effective? Queens Medical Center • NCCCP (NCI Community Cancers Program) site • Clinical Trial Nurse Assist Program • Utilizes trained navigators • Cooperates with Imi Hale and the MBCCOP • Success in increasing clinical trial accrual at hospital site • Having equal distribution in enrollment across ethnic groups
  36. 36. UHCC Current Research • Conduct ethnic-specific focus groups among Hawaii’s men and women to identify social and cultural attitudes, knowledge, and beliefs that may affect participation in clinical trials • Design of current study • interviews with Native Hawaiian men and women and Native Hawaiian cancer survivors • Our ultimate goal is to further improve the participation of underrepresented populations in cancer preventionand treatment trials and eliminate gender disparity seen in the Native Hawaiian population
  37. 37. Conclusions • Cancer disparities exist in Native Hawaiians • There are barriers to clinical trial participation both perceived and real • We have documented participation of different ethnic groups in cancer clinical trials • Together with our partner we have developed effective measures to increase enrollment in clinical trials • We are addressing remaining challenges
  38. 38. Acknowledgements Erin Bantum, Kevin Cassel, Iona Cheng, Lana Ka`opua, Joanne Tsark and Lynne Wilkens This study was supported in part by a number of grants:  U10CA63844 NIH MBCCOP  U10CA37377 NIH NSABP  U54CA153459 NIH Imi Hale  N01 PC 35137 HAWAII SEER PROGRAM

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