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. 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. 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

9. 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.

10. 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.

11. 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.

12. 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.

13. 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

15. 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

17. 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).

18. 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).

19. 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).

20. Ethnic Disparities in Late Stage Cancer, 2000-2005
Rates are age-adjusted to US 2000 standard.

21. Ethnic Disparities in Prostate Cancer
Hawai`i, 1975-2005

22. 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

23. Barriers to Clinical Trial Participation
• Feeling intimidated
• Not knowing what to ask
• Health care literacy
• Referring providers have little knowledge

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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%

32. 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%

33. 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%

34. 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

35. 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

36. 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)

37. 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

38. 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

39. 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

40. 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

41. 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

42. 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

43. 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

44. 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

45. 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