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ACRIN Fall meeting 10-2009
Minority Recruitment in the NLST
Catherine Duda, MPH Irene Mahon, RN, MPH
Mei Hsiu Chen, PhD Bradley Snyder, MS
Richard Barr, MD PhD Caroline Chiles, MD
Robert Falk, MD Elliott Fishman, MD
David Gemmel, PhD Jonathan G. Goldin, MD PhD
Reginald Munden, MD Kay Vydaryny, MD
Kathy Brown, MD Denise R. Aberle, MD
ACRIN Fall meeting 10-2009
ACRIN Fall meeting 10-2009
the problem
• Limited minority participation in prevention research• Impact:
– Generalizability | health care delivery– Equitably distribute risks and benefits of clinical trials
• Barriers– Lack of awareness of clinical trials– Lack of opportunity– Barriers of opportunity
ACRIN Fall meeting 10-2009
NLST ACRIN objectives
• Measure effects of targeted strategies on accruing underrepresented groups
• Characterize participant characteristics as result of strategies
• Estimate the costs of targeted enrollment
ACRIN Fall meeting 10-2009
methods
• Estimate proportions of racial/ethnic categories– Tobacco Use Supplement of the 1998-99 population survey– Proportions: 91.7% White, 6.3% African American,1.0% Asian,
1.0% American Indian/Alaskan native, 3.4% Hispanic
ACRIN Fall meeting 10-2009
methods
• Estimate proportions of racial/ethnic categories– Tobacco Use Supplement of the 1998-99 population survey– Proportions: 91.7% White, 6.3% African American,1.0% Asian,
1.0% American Indian/Alaskan native, 3.4% Hispanic
• Site selection criteria– Situated in cultural diverse settings: UC Census Bureau– Target recruitment strategies already implemented– Proven success in accruing minority populations
ACRIN Fall meeting 10-2009
methods - planning
• Strategic planning began March 2003 (month 7)
• Initial meeting: ACS, NCI, NCI OC, ACRIN leadership
• NLST ACRIN trial-wide conference calls– Introduce the minority recruitment plan– Review barriers | potential solutions
• Sites asked to submit recruitment plan with budget
• Supplemental funding was requested, not guaranteed
• 6 sites (1 site later participated)
Institution Location Population of Interest
Emory University Atlanta, GA African American
Jewish Heart and Lung Louisville, KY African American
Johns Hopkins University Baltimore, MD African American
M.D. Anderson Cancer Center Houston, TX Hispanic
St. Elizabeth’s Health System 1 Youngstown, OH African American
UCLA Jonsson Cancer Center Los Angeles, CA African American, Hispanic, Asian
Wake Forest University Winston-Salem, NC African American
1 St. Elizabeth’s Health System was not initially an accruing NLST-ACRIN institution, but later submitted a plan.
NLST-ACRIN minority institutions
Race | EthnicityMinority Sites
N (%)
Remaining Sites
N (%)
Total
N (%)
African American 895 (82%) 193 (18%) 1088 (100%)
Asian 81 (74%) 29 (26%) 110 (100%)
Hispanic / Latino 163 (67%) 82 (33%) 245 (100%)
> 1 race 70 (71%) 28 (29%) 98 (100%)
Total 1209 (78%) 332 (22%) 1541 (100%)
results: summary minority accrual
EmoryJewish
Heart and Lung
Johns Hopkins
MDASt
Elizabeth’s
UCLAWake Forest
All Minority Sites
All other Institutions
Total
Race N (%)
AA175
(14.3%)87
(4.4%)406
(24.3%)56
(7.1%)39
(3.7%)99
(6.3%)33
(3.0%)895
(9.5%)193
(2.0%)1088 (5.8%)
Asian1
(0.1%)5
(0.3%)5
(0.3%)4
(0.5%)5
(0.5%)57
(3.6%)4
(0.4%)81
(0.9%)29
(0.3%)110
(0.6%)
White1048
(85.3%)1876
(95.0%)1253
(74.9%)675
(86.0%)988
(94.5%)1349
(85.5%)1061
(95.8%)8250
(87.8%)9157
(96.9%)17407
(92.4%)
> 1 Race0
(0.0%)2
(0.1%)2
(0.1%)21
(2.7%)7
(0.7%)35
2.2%)3
(0.3%)70
(0.7%)28
(0.3%)98
(0.5%)
Ethnicity 1 N (%)
Hispanic11
(0.9%)10
(0.5%)8
(0.5%)40
(5.1%)22
(2.1%)67
(4.2%)5
(0.5%)163
(1.7%)82
(0.9%)245
(1.3%)
Non Hispanic
1216 (99.0%)
1960 (99.3%)
1665 (99.5%)
744 (94.8%)
1022 (97.7%)
1483 (94.0%)
1102 (99.5%)
9192 (97.9%)
9357 (99.0%)
18549 (98.4%)
Total1228
(100%)1974
(100%)1673
(100%)785
(100%)1046
(100%)1578
(100%)1108
(100%)9392
(100%)9450
(100%)18842 (100%)
results: site-specific accruals
EmoryJewish
Heart and Lung
Johns Hopkins
MDASt
Elizabeth’s
UCLAWake Forest
All Minority Sites
All other Institutions
Total
Race N (%)
AA175
(14.3%)87
(4.4%)406
(24.3%)56
(7.1%)39
(3.7%)99
(6.3%)33
(3.0%)895
(9.5%)193
(2.0%)1088 (5.8%)
Asian1
(0.1%)5
(0.3%)5
(0.3%)4
(0.5%)5
(0.5%)57
(3.6%)4
(0.4%)81
(0.9%)29
(0.3%)110
(0.6%)
White1048
(85.3%)1876
(95.0%)1253
(74.9%)675
(86.0%)988
(94.5%)1349
(85.5%)1061
(95.8%)8250
(87.8%)9157
(96.9%)17407
(92.4%)
> 1 Race0
(0.0%)2
(0.1%)2
(0.1%)21
(2.7%)7
(0.7%)35
2.2%)3
(0.3%)70
(0.7%)28
(0.3%)98
(0.5%)
Ethnicity 1 N (%)
Hispanic11
(0.9%)10
(0.5%)8
(0.5%)40
(5.1%)22
(2.1%)67
(4.2%)5
(0.5%)163
(1.7%)82
(0.9%)245
(1.3%)
Non Hispanic
1216 (99.0%)
1960 (99.3%)
1665 (99.5%)
744 (94.8%)
1022 (97.7%)
1483 (94.0%)
1102 (99.5%)
9192 (97.9%)
9357 (99.0%)
18549 (98.4%)
Total1228
(100%)1974
(100%)1673
(100%)785
(100%)1046
(100%)1578
(100%)1108
(100%)9392
(100%)9450
(100%)18842 (100%)
results: racial | ethnic characteristics
FeatureMinority
InstitutionNon-Minority
InstitutionTotal
Age at study consent
Median 61 61 61
Range 1 (55 - 74) (55 - 74) (55 - 74)
Smoking Status
Current smokers (%) 5052 (53.8%) 4463 (47.2%) 9515 (50.5%)
Former smokers (%) 4340 (46.2%) 4987 (52.8%) 9327 (49.5%)
Sex
Female 4020 (42.8%) 4417 (46.7%) 8437 (44.8%)
Male 5372 (57.2%) 5033 (53.3%) 1 10405 (55.2%)1 P < 0.001
results: age, smoking characteristics, sex
Minority Sites (N = 7) Other Sites (N = 16)
MinorityWhite Non-Hispanic 1 Total Minority
White Non-Hispanic 1 Total
Education N (%)Less than high school 217 (17.8%) 567 (6.9%) 784 (8.3%) 42 (11.9%) 423 (4.7%) 465 (4.9%)
High school graduate or GED 313 (25.6%) 1855 (22.7%) 2169 (23.1%) 71 (20.1%) 2106 (23.2%) 2178 (23.0%)
Post-high school:technology school, associate degree, some college
389 (31.8%) 2804 (34.4%) 3194 (34.0%) 121 (34.2%) 3141 (34.5%) 3264 (34.5%)
Bachelor’s degree 136 (11.1%) 1446 (17.7%) 1584 (16.9%) 43 (12.1%) 1565 (17.2%) 1608 (17.0%)
Graduate or professional school
133 (10.9%) 1277 (15.6%) 1412 (15.0%) 66 (18.6%) 1601 (17.6%) 1667 (17.6%)
Household income N (%)< $15,000 363 (29.7%) 776 (9.5%) 1139 (12.1%) 59 (16.7%) 621 (6.8%) 680 (7.2%)
$15,000 – $34,999 293 (24.0%) 1768 (21.7%) 2062 (22.0%) 84 (23.7%) 1917 (21.1%) 2001 (21.2%)
$35,000 - $64,999 223 (18.2%) 2268 (27.8%) 2492 (26.5%) 89 (25.1%) 2737 (30.1%) 2828 (29.9%)
$65,000 - $100,000 122 (10.0%) 1396 (17.1%) 1518 (16.2%) 42 (11.9%) 1700 (18.7%) 1742 (18.4%)
> $100,000 64 (5.2%) 892 (10.9%) 958 (10.2%) 28 (7.9%) 1001 (11.0%) 1029 (10.9%)
results: education | income
Minority Sites (N = 7) Other Sites (N = 16)
MinorityWhite Non-Hispanic 1 Total Minority
White Non-Hispanic 1 Total
Education N (%)Less than high school 217 (17.8%) 567 (6.9%) 784 (8.3%) 42 (11.9%) 423 (4.7%) 465 (4.9%)
High school graduate or GED 313 (25.6%) 1855 (22.7%) 2169 (23.1%) 71 (20.1%) 2106 (23.2%) 2178 (23.0%)
Post-high school:technology school, associate degree, some college
389 (31.8%) 2804 (34.4%) 3194 (34.0%) 121 (34.2%) 3141 (34.5%) 3264 (34.5%)
Bachelor’s degree 136 (11.1%) 1446 (17.7%) 1584 (16.9%) 43 (12.1%) 1565 (17.2%) 1608 (17.0%)
Graduate or professional school
133 (10.9%) 1277 (15.6%) 1412 (15.0%) 66 (18.6%) 1601 (17.6%) 1667 (17.6%)
Household income N (%)< $15,000 363 (29.7%) 776 (9.5%) 1139 (12.1%) 59 (16.7%) 621 (6.8%) 680 (7.2%)
$15,000 – $34,999 293 (24.0%) 1768 (21.7%) 2062 (22.0%) 84 (23.7%) 1917 (21.1%) 2001 (21.2%)
$35,000 - $64,999 223 (18.2%) 2268 (27.8%) 2492 (26.5%) 89 (25.1%) 2737 (30.1%) 2828 (29.9%)
$65,000 - $100,000 122 (10.0%) 1396 (17.1%) 1518 (16.2%) 42 (11.9%) 1700 (18.7%) 1742 (18.4%)
> $100,000 64 (5.2%) 892 (10.9%) 958 (10.2%) 28 (7.9%) 1001 (11.0%) 1029 (10.9%)
results: education | income
Minority Sites (N = 7) Other Sites (N = 16)
MinorityWhite Non-Hispanic 1 Total Minority
White Non-Hispanic 1 Total
Education N (%)Less than high school 217 (17.8%) 567 (6.9%) 784 (8.3%) 42 (11.9%) 423 (4.7%) 465 (4.9%)
High school graduate or GED 313 (25.6%) 1855 (22.7%) 2169 (23.1%) 71 (20.1%) 2106 (23.2%) 2178 (23.0%)
Post-high school:technology school, associate degree, some college
389 (31.8%) 2804 (34.4%) 3194 (34.0%) 121 (34.2%) 3141 (34.5%) 3264 (34.5%)
Bachelor’s degree 136 (11.1%) 1446 (17.7%) 1584 (16.9%) 43 (12.1%) 1565 (17.2%) 1608 (17.0%)
Graduate or professional school
133 (10.9%) 1277 (15.6%) 1412 (15.0%) 66 (18.6%) 1601 (17.6%) 1667 (17.6%)
Household income N (%)< $15,000 363 (29.7%) 776 (9.5%) 1139 (12.1%) 59 (16.7%) 621 (6.8%) 680 (7.2%)
$15,000 – $34,999 293 (24.0%) 1768 (21.7%) 2062 (22.0%) 84 (23.7%) 1917 (21.1%) 2001 (21.2%)
$35,000 - $64,999 223 (18.2%) 2268 (27.8%) 2492 (26.5%) 89 (25.1%) 2737 (30.1%) 2828 (29.9%)
$65,000 - $100,000 122 (10.0%) 1396 (17.1%) 1518 (16.2%) 42 (11.9%) 1700 (18.7%) 1742 (18.4%)
> $100,000 64 (5.2%) 892 (10.9%) 958 (10.2%) 28 (7.9%) 1001 (11.0%) 1029 (10.9%)
results: education | income
Minority Sites (N = 7) Other Sites (N = 16)
MinorityWhite Non-Hispanic 1 Total Minority
White Non-Hispanic 1 Total
Education N (%)Less than high school 217 (17.8%) 567 (6.9%) 784 (8.3%) 42 (11.9%) 423 (4.7%) 465 (4.9%)
High school graduate or GED 313 (25.6%) 1855 (22.7%) 2169 (23.1%) 71 (20.1%) 2106 (23.2%) 2178 (23.0%)
Post-high school:technology school, associate degree, some college
389 (31.8%) 2804 (34.4%) 3194 (34.0%) 121 (34.2%) 3141 (34.5%) 3264 (34.5%)
Bachelor’s degree 136 (11.1%) 1446 (17.7%) 1584 (16.9%) 43 (12.1%) 1565 (17.2%) 1608 (17.0%)
Graduate or professional school
133 (10.9%) 1277 (15.6%) 1412 (15.0%) 66 (18.6%) 1601 (17.6%) 1667 (17.6%)
Household income N (%)< $15,000 363 (29.7%) 776 (9.5%) 1139 (12.1%) 59 (16.7%) 621 (6.8%) 680 (7.2%)
$15,000 – $34,999 293 (24.0%) 1768 (21.7%) 2062 (22.0%) 84 (23.7%) 1917 (21.1%) 2001 (21.2%)
$35,000 - $64,999 223 (18.2%) 2268 (27.8%) 2492 (26.5%) 89 (25.1%) 2737 (30.1%) 2828 (29.9%)
$65,000 - $100,000 122 (10.0%) 1396 (17.1%) 1518 (16.2%) 42 (11.9%) 1700 (18.7%) 1742 (18.4%)
> $100,000 64 (5.2%) 892 (10.9%) 958 (10.2%) 28 (7.9%) 1001 (11.0%) 1029 (10.9%)
results: education | income
Minority Sites (N = 7) Other Sites (N = 16)
MinorityWhite Non-Hispanic 1 Total Minority
White Non-Hispanic 1 Total
Education N (%)Less than high school 217 (17.8%) 567 (6.9%) 784 (8.3%) 42 (11.9%) 423 (4.7%) 465 (4.9%)
High school graduate or GED 313 (25.6%) 1855 (22.7%) 2169 (23.1%) 71 (20.1%) 2106 (23.2%) 2178 (23.0%)
Post-high school:technology school, associate degree, some college
389 (31.8%) 2804 (34.4%) 3194 (34.0%) 121 (34.2%) 3141 (34.5%) 3264 (34.5%)
Bachelor’s degree 136 (11.1%) 1446 (17.7%) 1584 (16.9%) 43 (12.1%) 1565 (17.2%) 1608 (17.0%)
Graduate or professional school
133 (10.9%) 1277 (15.6%) 1412 (15.0%) 66 (18.6%) 1601 (17.6%) 1667 (17.6%)
Household income N (%)< $15,000 363 (29.7%) 776 (9.5%) 1139 (12.1%) 59 (16.7%) 621 (6.8%) 680 (7.2%)
$15,000 – $34,999 293 (24.0%) 1768 (21.7%) 2062 (22.0%) 84 (23.7%) 1917 (21.1%) 2001 (21.2%)
$35,000 - $64,999 223 (18.2%) 2268 (27.8%) 2492 (26.5%) 89 (25.1%) 2737 (30.1%) 2828 (29.9%)
$65,000 - $100,000 122 (10.0%) 1396 (17.1%) 1518 (16.2%) 42 (11.9%) 1700 (18.7%) 1742 (18.4%)
> $100,000 64 (5.2%) 892 (10.9%) 958 (10.2%) 28 (7.9%) 1001 (11.0%) 1029 (10.9%)
results: education | income
Minority Sites (N = 7) Other Sites (N = 16)
Minority Participants
White | Non-Hispanic 1 Total
Minority Participants
White | Non-Hispanic 1 Total
Insurance Status N (%)
Private insurance and/or Medicare
859 (70.3%)7158
(87.7%)8024
(85.4%)278 (78.5%)
8218 (90.4%)
8499 (89.9%)
Medicaid 38 (3.1%) 42 (0.5%) 80 (0.9%) 10 (2.8%) 77 (0.8%) 87 (0.9%)
Medicaid and Medicare
35 (2.9%) 54 (0.7%) 89 (0.9%) 13 (3.7%) 83 (0.9%) 96 (1.0%)
Military or Veteran’s Administration
68 (5.6%) 278 (3.4%) 346 (3.7%) 17 (4.8%) 227 (2.5%) 244 (2.6%)
No insurance 191 (15.6%) 514 (6.3%) 706 (7.5%) 26 (7.3%) 341 (3.8%) 367 (3.9%)
Total 1222 (100%) 8162 (100%) 9392 (100%) 354 (100%) 9092 (100%) 9450 (100%)
results: medical insurance
results: enrollment pre- & post implementation
Type of Institution Time Period 1
Minority participant
N (%)
White/Non-Hispanic
N (%)Total
Institutions with Targeted Recruitment Strategies
Pre-Implementation 322 (9.3%) 3153 (90.6%) 3479
Post-Implementation 900 (15.2%) 5009 (84.7%) 5913
Other InstitutionsPre-Implementation 113 (3.6%) 3058 (96.3%) 3174
Post-Implementation 241 (3.8%) 6034 (96.1%) 6276
Total 1576 (8.4%) 17254 (91.6%) 18842
1 Pre-implementation refers to the period on or prior to 5/31/2003
results: enrollment pre- & post implementation
Type of Institution Time Period 1 Minority participant
White/Non-Hispanic
participant 2
Total
Institutions with Targeted Recruitment Strategies
Pre-Implementation 322 (9.3%) 3153 (90.6%) 3479
Post-Implementation 900 (15.2%) 5009 (84.7%) 5913
Other InstitutionsPre-Implementation 113 (3.6%) 3058 (96.3%) 3174
Post-Implementation 241 (3.8%) 6034 (96.1%) 6276
Total 1576 (8.4%) 17254 (91.6%) 18842
1 Pre-implementation refers to the period on or prior to 5/31/2003
results: enrollment pre- & post implementation
Type of Institution Time Period 1 Minority participant
White/Non-Hispanic
participant 2
Total
Institutions with Targeted Recruitment Strategies
Pre-Implementation 322 (9.3%) 3153 (90.6%) 3479
Post-Implementation 900 (15.2%) 5009 (84.7%) 5913
Other InstitutionsPre-Implementation 113 (3.6%) 3058 (96.3%) 3174
Post-Implementation 241 (3.8%) 6034 (96.1%) 6276
Total 1576 (8.4%) 17254 (91.6%) 18842
1 Pre-implementation refers to the period on or prior to 5/31/2003
results: minority recruitment strategies by site
results: minority recruitment strategies by site
results: minority recruitment strategies by site
results: minority recruitment strategies by site
results: minority recruitment strategies by site
results: minority recruitment strategies by site
results: minority recruitment strategies by site
results: minority recruitment strategies by site
ACRIN Fall meeting 10-2009
• A priori accrual goals based on racial/ethnic proportions
• Minority enrollment a factor in site selection
• Recruitment planning well in advance
• Flexibility in eligibility1
• Endorsement by prominent representatives of the racial groups of interest1
1: SELECT: Phase III chemoprevention trial for prostate cancer: N = 35,53422% minorities: 15% AA | 6% Hispanic | 1% Asian
discussion: strategic approaches
ACRIN Fall meeting 10-2009
• A priori accrual goals based on racial/ethnic proportions
• Minority enrollment a factor in site selection
• Recruitment planning well in advance
• Flexibility in eligibility1
• Endorsement by prominent representatives of the racial groups of interest1
1: SELECT: Phase III chemoprevention trial for prostate cancer: N = 35,53422% minorities: 15% AA | 6% Hispanic | 1% Asian
discussion: strategic approaches
ACRIN Fall meeting 10-2009
• A priori accrual goals based on racial/ethnic proportions
• Minority enrollment a factor in site selection
• Recruitment planning well in advance
• Flexibility in eligibility1
• Endorsement by prominent representatives of the racial groups of interest1
1: SELECT: Phase III chemoprevention trial for prostate cancer: N = 35,53422% minorities: 15% AA | 6% Hispanic | 1% Asian
discussion: strategic approaches
ACRIN Fall meeting 10-2009
• A priori accrual goals based on racial/ethnic proportions
• Minority enrollment a factor in site selection
• Recruitment planning well in advance
• Flexibility in eligibility1
• Endorsement by prominent representatives of the racial groups of interest1
1: SELECT: Phase III chemoprevention trial for prostate cancer: N = 35,53422% minorities: 15% AA | 6% Hispanic | 1% Asian
discussion: strategic approaches
ACRIN Fall meeting 10-2009
• A priori accrual goals based on racial/ethnic proportions
• Minority enrollment a factor in site selection
• Recruitment planning well in advance
• Flexibility in eligibility1
• Endorsement by prominent representatives of the racial groups of interest1
1: SELECT: Phase III chemoprevention trial for prostate cancer: N = 35,53422% minorities: 15% AA | 6% Hispanic | 1% Asian
discussion: strategic approaches
ACRIN Fall meeting 10-2009
• Awareness– Grass roots education: Churches, clinics/providers, trial champions– Targeted advertising & mailing
• Opportunity– Access: Site hours | transportation | reimburse time & travel– Insurance status: site diagnostic testing | clinic referrals– Trial requirements and duration
• Individual beliefs: barriers of perspective
discussion: strategic approaches
ACRIN Fall meeting 10-2009
limitations
• No standard documentation of reasons for non-participation
• Incomplete description of recruitment methods– “Other” and “word of mouth” incorporates
• Grass roots efforts• Dedicated minority staff• Media ads: newspaper ads
• Site experience and organizational structure
ACRIN Fall meeting 10-2009
conclusions
• Targeted strategies increase racial/ethnic representation
• Sites with targeted strategies accounted for 80% of all minorities enrolled
– Dominated minority accrual pre-implementation– 60% increase in minority accrual post-implementation
• No single strategy effective across all sites
• Costs associated with targeted accrual | highly variable