Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and...

44
Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Elise D. Cook, M.D. Chair, Minority and Medically Chair, Minority and Medically Underserved Subcommittee, SELECT Underserved Subcommittee, SELECT Chair, Sites at Risk Review Chair, Sites at Risk Review Committee, SELECT Committee, SELECT June 15, 2009 Houston, TX

Transcript of Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and...

Page 1: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Recruiting African American Men to a

Cancer Prevention Trial

Elise D. Cook, M.D.Elise D. Cook, M.D.

Chair, Minority and Medically Underserved Chair, Minority and Medically Underserved Subcommittee, SELECTSubcommittee, SELECT

Chair, Sites at Risk Review Committee, Chair, Sites at Risk Review Committee, SELECTSELECT

June 15, 2009 Houston, TX

Page 2: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT RolesSELECT Roles• Principal InvestigatorPrincipal Investigator

– M. D. Anderson Cancer Center SiteM. D. Anderson Cancer Center Site

• ChairChair– SELECT Minority and Medically Underserved SELECT Minority and Medically Underserved

SubcommitteeSubcommittee– Sites at Risk Review CommitteeSites at Risk Review Committee

• Co-ChairCo-Chair– SELECT Retention and Adherence Committee (RAC)SELECT Retention and Adherence Committee (RAC)– Chair, RAC Publications Working GroupChair, RAC Publications Working Group– Chair, RAC Planning Working GroupChair, RAC Planning Working Group

• Participant’s SpouseParticipant’s Spouse

• Principal InvestigatorPrincipal Investigator– M. D. Anderson Cancer Center SiteM. D. Anderson Cancer Center Site

• ChairChair– SELECT Minority and Medically Underserved SELECT Minority and Medically Underserved

SubcommitteeSubcommittee– Sites at Risk Review CommitteeSites at Risk Review Committee

• Co-ChairCo-Chair– SELECT Retention and Adherence Committee (RAC)SELECT Retention and Adherence Committee (RAC)– Chair, RAC Publications Working GroupChair, RAC Publications Working Group– Chair, RAC Planning Working GroupChair, RAC Planning Working Group

• Participant’s SpouseParticipant’s Spouse

Page 3: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,
Page 4: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Primary ObjectivePrimary Objective

Assess the effects of selenium and vitamin E Assess the effects of selenium and vitamin E alone and in combination on the alone and in combination on the

clinical incidence of prostate cancerclinical incidence of prostate cancer

Assess the effects of selenium and vitamin E Assess the effects of selenium and vitamin E alone and in combination on the alone and in combination on the

clinical incidence of prostate cancerclinical incidence of prostate cancer

Page 5: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT Trial DesignSELECT Trial Design

• Double blindDouble blind

• Placebo controlledPlacebo controlled

• 2 x 2 factorial2 x 2 factorial

• 32,400 men32,400 men

• 5 year accrual5 year accrual

• Double blindDouble blind

• Placebo controlledPlacebo controlled

• 2 x 2 factorial2 x 2 factorial

• 32,400 men32,400 men

• 5 year accrual5 year accrual

Page 6: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

MinoritiesMinorities

Census effects on classification of race and Census effects on classification of race and ethnicityethnicity2000 Census Race Categories2000 Census Race Categories

• White, black, Native American, Asian, Asian Pacific White, black, Native American, Asian, Asian Pacific Islander, some other race (select one or more)Islander, some other race (select one or more)

2000 Census Ethnicity 2000 Census Ethnicity • Hispanic or Latino identity is considered ethnicityHispanic or Latino identity is considered ethnicity• Latinos may be any raceLatinos may be any race

Census effects on classification of race and Census effects on classification of race and ethnicityethnicity2000 Census Race Categories2000 Census Race Categories

• White, black, Native American, Asian, Asian Pacific White, black, Native American, Asian, Asian Pacific Islander, some other race (select one or more)Islander, some other race (select one or more)

2000 Census Ethnicity 2000 Census Ethnicity • Hispanic or Latino identity is considered ethnicityHispanic or Latino identity is considered ethnicity• Latinos may be any raceLatinos may be any race

Page 7: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Why include Underrepresented Subgroups?

Why include Underrepresented Subgroups?

Valid, generalizable data requires the Valid, generalizable data requires the inclusion of subgroups proportionate to inclusion of subgroups proportionate to

the general population.the general population.

Valid, generalizable data requires the Valid, generalizable data requires the inclusion of subgroups proportionate to inclusion of subgroups proportionate to

the general population.the general population.

Page 8: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT Minority Recruitment Goals

SELECT Minority Recruitment Goals

• African American – 20%African American – 20%– Racial group most affected by CaPRacial group most affected by CaP

• Hispanic – 3%Hispanic – 3%

• Asian American – 1%Asian American – 1%

• African American – 20%African American – 20%– Racial group most affected by CaPRacial group most affected by CaP

• Hispanic – 3%Hispanic – 3%

• Asian American – 1%Asian American – 1%

Page 9: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,
Page 10: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT AccrualSELECT Accrual

• Activated July 25, 2001Activated July 25, 2001

• Accrual closed June 24, 2004Accrual closed June 24, 2004

• National accrual goal of 32,400 men was National accrual goal of 32,400 men was reached 28 months earlier than projected!!reached 28 months earlier than projected!!

• Activated July 25, 2001Activated July 25, 2001

• Accrual closed June 24, 2004Accrual closed June 24, 2004

• National accrual goal of 32,400 men was National accrual goal of 32,400 men was reached 28 months earlier than projected!!reached 28 months earlier than projected!!

Page 11: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

– Planning PhasePlanning Phase– Recruitment PhaseRecruitment Phase– Follow-up Phase Follow-up Phase

7 to 12 years is a long time!!!7 to 12 years is a long time!!!

– Planning PhasePlanning Phase– Recruitment PhaseRecruitment Phase– Follow-up Phase Follow-up Phase

7 to 12 years is a long time!!!7 to 12 years is a long time!!!

SELECT SELECT

Challenges and Lessons LearnedChallenges and Lessons Learned

Page 12: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT Pre-recruitment PhaseSELECT Pre-recruitment Phase

• Eligibility Criteria changesEligibility Criteria changes– Performance Status change from 0 to 1Performance Status change from 0 to 1– Eligibility age for African American men Eligibility age for African American men

decreased to from 55 to 50 - reflects equivalent decreased to from 55 to 50 - reflects equivalent risk of prostate cancerrisk of prostate cancer

• Eligibility Criteria changesEligibility Criteria changes– Performance Status change from 0 to 1Performance Status change from 0 to 1– Eligibility age for African American men Eligibility age for African American men

decreased to from 55 to 50 - reflects equivalent decreased to from 55 to 50 - reflects equivalent risk of prostate cancerrisk of prostate cancer

Page 13: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT Recruitment PhaseSELECT Recruitment Phase

• Overall recruitment occurred rapidlyOverall recruitment occurred rapidly

• African American recruitment goal = 20%African American recruitment goal = 20%

• Unable to make this goal with such rapid Unable to make this goal with such rapid recruitmentrecruitment

• Strategies were implemented to achieve Strategies were implemented to achieve African American recruitment at 15%African American recruitment at 15%

• Overall recruitment occurred rapidlyOverall recruitment occurred rapidly

• African American recruitment goal = 20%African American recruitment goal = 20%

• Unable to make this goal with such rapid Unable to make this goal with such rapid recruitmentrecruitment

• Strategies were implemented to achieve Strategies were implemented to achieve African American recruitment at 15%African American recruitment at 15%

Page 14: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

National Participant Advisory Board Appointed July 2003

National Participant Advisory Board Appointed July 2003

Page 15: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Barriers to RecruitmentBarriers to Recruitment

• Study Design (Inclusion/Exclusion Criteria)Study Design (Inclusion/Exclusion Criteria)

• Physician impact (knowledge, attitude, time)Physician impact (knowledge, attitude, time)

• Economic issues (cost to participate)Economic issues (cost to participate)

• Personal / Cultural influences (historical Personal / Cultural influences (historical treatment by healthcare system)treatment by healthcare system)

• Study Design (Inclusion/Exclusion Criteria)Study Design (Inclusion/Exclusion Criteria)

• Physician impact (knowledge, attitude, time)Physician impact (knowledge, attitude, time)

• Economic issues (cost to participate)Economic issues (cost to participate)

• Personal / Cultural influences (historical Personal / Cultural influences (historical treatment by healthcare system)treatment by healthcare system)

Page 16: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Prevention Trial Recruitment Issues

Prevention Trial Recruitment Issues

• Healthy individualsHealthy individuals– Sometimes unaware of the disease or organ being Sometimes unaware of the disease or organ being

studied studied example: prostate cancer, ovarian cancerexample: prostate cancer, ovarian cancer

• Fewer clinic visits available to “tag-on” researchFewer clinic visits available to “tag-on” research– (increases study costs)(increases study costs)

• Long follow-up period (more expensive)Long follow-up period (more expensive)– (adherence and retention are important issues)(adherence and retention are important issues)

• More expansive recruitment strategiesMore expansive recruitment strategies

• Healthy individualsHealthy individuals– Sometimes unaware of the disease or organ being Sometimes unaware of the disease or organ being

studied studied example: prostate cancer, ovarian cancerexample: prostate cancer, ovarian cancer

• Fewer clinic visits available to “tag-on” researchFewer clinic visits available to “tag-on” research– (increases study costs)(increases study costs)

• Long follow-up period (more expensive)Long follow-up period (more expensive)– (adherence and retention are important issues)(adherence and retention are important issues)

• More expansive recruitment strategiesMore expansive recruitment strategies

Page 17: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Recruitment ProcessRecruitment Process

1. Identify internal and external resources1. Identify internal and external resources2. Set recruitment goals2. Set recruitment goals3. Develop strategies3. Develop strategies4. (Re)-prioritize strategies4. (Re)-prioritize strategies5. Implement strategies5. Implement strategies6. Evaluate strategy 6. Evaluate strategy 8 Monitor accrual, adherence and retention8 Monitor accrual, adherence and retention7. Retain, revise or remove strategies7. Retain, revise or remove strategies

1. Identify internal and external resources1. Identify internal and external resources2. Set recruitment goals2. Set recruitment goals3. Develop strategies3. Develop strategies4. (Re)-prioritize strategies4. (Re)-prioritize strategies5. Implement strategies5. Implement strategies6. Evaluate strategy 6. Evaluate strategy 8 Monitor accrual, adherence and retention8 Monitor accrual, adherence and retention7. Retain, revise or remove strategies7. Retain, revise or remove strategies

Page 18: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Minority Recruitment BarriersMinority Recruitment Barriers

– LanguageLanguage– Other cultural communication issuesOther cultural communication issues– Attitudes and beliefs Attitudes and beliefs – Access to health care Access to health care – Current health status Current health status – Socio-demographic factorsSocio-demographic factors

– LanguageLanguage– Other cultural communication issuesOther cultural communication issues– Attitudes and beliefs Attitudes and beliefs – Access to health care Access to health care – Current health status Current health status – Socio-demographic factorsSocio-demographic factors

Page 19: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Recruitment in Special Populations

Recruitment in Special Populations

• Cultural competence is keyCultural competence is key– Develop a long-term relationship with the Develop a long-term relationship with the

communitycommunity– Translated materials Translated materials – Low literacy Low literacy – Eliminate costs associated with the clinical Eliminate costs associated with the clinical

trial if possibletrial if possible

• Cultural competence is keyCultural competence is key– Develop a long-term relationship with the Develop a long-term relationship with the

communitycommunity– Translated materials Translated materials – Low literacy Low literacy – Eliminate costs associated with the clinical Eliminate costs associated with the clinical

trial if possibletrial if possible

Page 20: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

African American RecruitmentAfrican American Recruitment

– Trust and respect are huge issues with Trust and respect are huge issues with African American subjectsAfrican American subjects

– Tuskegee Syphilis Study– Prior negative experiences in the U.S. health Prior negative experiences in the U.S. health

care systemcare system

– Trust and respect are huge issues with Trust and respect are huge issues with African American subjectsAfrican American subjects

– Tuskegee Syphilis Study– Prior negative experiences in the U.S. health Prior negative experiences in the U.S. health

care systemcare system

Page 21: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Tuskegee Syphilis StudyTuskegee Syphilis Study

• 1932 to 1972 by the USPHS• Document the natural history of syphilis • African American researchers also involved• Subjects told they had “bad blood” – deception• Cover up involved preventing military service

• 1932 to 1972 by the USPHS• Document the natural history of syphilis • African American researchers also involved• Subjects told they had “bad blood” – deception• Cover up involved preventing military service

Page 22: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Tuskegee Syphilis StudyTuskegee Syphilis Study

Benefits

• free meals

• free medical examinations

• Burial Insurance

Benefits

• free meals

• free medical examinations

• Burial Insurance

Page 23: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT and TuskegeeSELECT and Tuskegee

SELECT Workbench:SELECT Workbench:

Staff training tool – Fact SheetStaff training tool – Fact Sheet

“ “Background Information on the Tuskegee Syphilis Study”

SELECT Workshop: SELECT Workshop:

Presentation - Tuskegee Syphilis Study Presentation - Tuskegee Syphilis Study

SELECT Workbench:SELECT Workbench:

Staff training tool – Fact SheetStaff training tool – Fact Sheet

“ “Background Information on the Tuskegee Syphilis Study”

SELECT Workshop: SELECT Workshop:

Presentation - Tuskegee Syphilis Study Presentation - Tuskegee Syphilis Study

Page 24: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Minority Recruitment to SELECTMinority Recruitment to SELECT

• Pre-activation Recruitment Strategies

• Study Activation Recruitment Strategies

• Post-activation Recruitment Strategies

• Results

• Pre-activation Recruitment Strategies

• Study Activation Recruitment Strategies

• Post-activation Recruitment Strategies

• Results

Page 25: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT Pre-activation Recruitment Strategies

SELECT Pre-activation Recruitment Strategies

• FOCUS GROUPS FOCUS GROUPS

• ELIGIBILITY CRITERION ELIGIBILITY CRITERION

• SITE INCLUSIONSITE INCLUSION

• INFRASTRUCTURE INFRASTRUCTURE

• SELECT WORKBENCHSELECT WORKBENCH

• SELECT WORKSHOPSELECT WORKSHOP

• FOCUS GROUPS FOCUS GROUPS

• ELIGIBILITY CRITERION ELIGIBILITY CRITERION

• SITE INCLUSIONSITE INCLUSION

• INFRASTRUCTURE INFRASTRUCTURE

• SELECT WORKBENCHSELECT WORKBENCH

• SELECT WORKSHOPSELECT WORKSHOP

Page 26: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

FOCUS GROUPSFOCUS GROUPS

• Input from men in the target populationInput from men in the target population• 78 men participated with 16 African American and 32 78 men participated with 16 African American and 32

from the VA systemfrom the VA system• Recommendations regarding communicationsRecommendations regarding communications

– Highlight personal incentivesHighlight personal incentives– Explain why the study supplements were chosenExplain why the study supplements were chosen– Provide frequent study updatesProvide frequent study updates– Include family members especially spousesInclude family members especially spouses– Special strategies for recruitment of minority, low literacy, Special strategies for recruitment of minority, low literacy,

low income and medically underserved menlow income and medically underserved men

• Input from men in the target populationInput from men in the target population• 78 men participated with 16 African American and 32 78 men participated with 16 African American and 32

from the VA systemfrom the VA system• Recommendations regarding communicationsRecommendations regarding communications

– Highlight personal incentivesHighlight personal incentives– Explain why the study supplements were chosenExplain why the study supplements were chosen– Provide frequent study updatesProvide frequent study updates– Include family members especially spousesInclude family members especially spouses– Special strategies for recruitment of minority, low literacy, Special strategies for recruitment of minority, low literacy,

low income and medically underserved menlow income and medically underserved men

Page 27: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Eligibility Criteria ChangesEligibility Criteria Changes

• Performance Status change from 0 to 1Performance Status change from 0 to 1– More co-morbid conditions are prevalent in More co-morbid conditions are prevalent in

minoritiesminorities

• Minimal age lowered to 50 for African Minimal age lowered to 50 for African AmericansAmericans– Risk of CaP for African American men at age Risk of CaP for African American men at age

50 50 ≥≥ risk for men of any other race at 55 risk for men of any other race at 55

• Performance Status change from 0 to 1Performance Status change from 0 to 1– More co-morbid conditions are prevalent in More co-morbid conditions are prevalent in

minoritiesminorities

• Minimal age lowered to 50 for African Minimal age lowered to 50 for African AmericansAmericans– Risk of CaP for African American men at age Risk of CaP for African American men at age

50 50 ≥≥ risk for men of any other race at 55 risk for men of any other race at 55

Page 28: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Site InclusionSite Inclusion

• Extra consideration to sites with access to large Extra consideration to sites with access to large minority populationsminority populations

• Antihypertensive and Lipid-Lowering Treatment Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)to Prevent Heart Attack Trial (ALLHAT)

• Women’s Health Initiative (WHI) sitesWomen’s Health Initiative (WHI) sites• VA sitesVA sites• Minority-Based Community Clinical Oncology Minority-Based Community Clinical Oncology

Program (MB-CCOP) sitesProgram (MB-CCOP) sites

• Extra consideration to sites with access to large Extra consideration to sites with access to large minority populationsminority populations

• Antihypertensive and Lipid-Lowering Treatment Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)to Prevent Heart Attack Trial (ALLHAT)

• Women’s Health Initiative (WHI) sitesWomen’s Health Initiative (WHI) sites• VA sitesVA sites• Minority-Based Community Clinical Oncology Minority-Based Community Clinical Oncology

Program (MB-CCOP) sitesProgram (MB-CCOP) sites

Page 29: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT Pre-activation Recruitment Strategies

SELECT Pre-activation Recruitment Strategies

• INFRASTRUCTURE – INFRASTRUCTURE – MMUS of the RAC, a MMUS of the RAC, a full-time SELECT MMUS recruitment and full-time SELECT MMUS recruitment and adherence coordinatoradherence coordinator

• WORKBENCH – WORKBENCH – password protected password protected Website with study and recruitment materialsWebsite with study and recruitment materials

• SELECT WORKSHOP - SELECT WORKSHOP - semi-annually with semi-annually with funding for one representative per site to funding for one representative per site to attendattend

• INFRASTRUCTURE – INFRASTRUCTURE – MMUS of the RAC, a MMUS of the RAC, a full-time SELECT MMUS recruitment and full-time SELECT MMUS recruitment and adherence coordinatoradherence coordinator

• WORKBENCH – WORKBENCH – password protected password protected Website with study and recruitment materialsWebsite with study and recruitment materials

• SELECT WORKSHOP - SELECT WORKSHOP - semi-annually with semi-annually with funding for one representative per site to funding for one representative per site to attendattend

Page 30: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

INFRASTRUCTUREINFRASTRUCTURE

• Recruitment and Adherence Committee and Recruitment and Adherence Committee and later the Retention and Adherence Committee later the Retention and Adherence Committee (RAC)(RAC)

• Minority and Medically Underserved Minority and Medically Underserved Subcommittee (MMUS)Subcommittee (MMUS)– Diverse expertise (NBLIC II, CDCP, NCI, NMA, VA, Diverse expertise (NBLIC II, CDCP, NCI, NMA, VA,

SWOG Statistical Center and Operations Office)SWOG Statistical Center and Operations Office)

• Recruitment and Adherence CoordinatorsRecruitment and Adherence Coordinators

• Recruitment and Adherence Committee and Recruitment and Adherence Committee and later the Retention and Adherence Committee later the Retention and Adherence Committee (RAC)(RAC)

• Minority and Medically Underserved Minority and Medically Underserved Subcommittee (MMUS)Subcommittee (MMUS)– Diverse expertise (NBLIC II, CDCP, NCI, NMA, VA, Diverse expertise (NBLIC II, CDCP, NCI, NMA, VA,

SWOG Statistical Center and Operations Office)SWOG Statistical Center and Operations Office)

• Recruitment and Adherence CoordinatorsRecruitment and Adherence Coordinators

Page 31: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT WORKBENCHSELECT WORKBENCH

• Password-protected web sitePassword-protected web site• Intended for study site useIntended for study site use• SELECT study materials, documents and SELECT study materials, documents and

reportsreports• Monthly, overall and African American Monthly, overall and African American

accrual reports listed by siteaccrual reports listed by site• MMUS and RAC performed regular MMUS and RAC performed regular

evaluations of recruitmentevaluations of recruitment

• Password-protected web sitePassword-protected web site• Intended for study site useIntended for study site use• SELECT study materials, documents and SELECT study materials, documents and

reportsreports• Monthly, overall and African American Monthly, overall and African American

accrual reports listed by siteaccrual reports listed by site• MMUS and RAC performed regular MMUS and RAC performed regular

evaluations of recruitmentevaluations of recruitment

Page 32: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SWOG/SELECT WORKSHOPSWOG/SELECT WORKSHOP

• Funding provided for 1 representative Funding provided for 1 representative per site to attend a 1 ½ day workshopper site to attend a 1 ½ day workshop

• Coincides with the semi-annual SWOG Coincides with the semi-annual SWOG meetings (Cost effective)meetings (Cost effective)

• Funding provided for 1 representative Funding provided for 1 representative per site to attend a 1 ½ day workshopper site to attend a 1 ½ day workshop

• Coincides with the semi-annual SWOG Coincides with the semi-annual SWOG meetings (Cost effective)meetings (Cost effective)

Page 33: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SWOG/SELECT WORKSHOPSWOG/SELECT WORKSHOP

• Each workshop includesEach workshop includes– Session for new staffSession for new staff– General session to provide SELECT status updatesGeneral session to provide SELECT status updates– Protocol or procedural changesProtocol or procedural changes– Discuss relevant researchDiscuss relevant research– ½ day poster session½ day poster session

• Sites display recruitment and adherence materials and Sites display recruitment and adherence materials and programsprograms

• Features partner organizationsFeatures partner organizations• Key elements of SELECTKey elements of SELECT

• Each workshop includesEach workshop includes– Session for new staffSession for new staff– General session to provide SELECT status updatesGeneral session to provide SELECT status updates– Protocol or procedural changesProtocol or procedural changes– Discuss relevant researchDiscuss relevant research– ½ day poster session½ day poster session

• Sites display recruitment and adherence materials and Sites display recruitment and adherence materials and programsprograms

• Features partner organizationsFeatures partner organizations• Key elements of SELECTKey elements of SELECT

Page 34: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT Study Activation Recruitment

Strategies

SELECT Study Activation Recruitment

Strategies

• National press release National press release – About 13% African American responseAbout 13% African American response

• Many local SELECT releasesMany local SELECT releases

• National press release National press release – About 13% African American responseAbout 13% African American response

• Many local SELECT releasesMany local SELECT releases

Page 35: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT Post-activation Recruitment Strategies

SELECT Post-activation Recruitment Strategies

• Minority Recruitment Enhancement GrantsMinority Recruitment Enhancement Grants

• Minority Recruitment Workshops Minority Recruitment Workshops

• Partnership with NBLIC IIPartnership with NBLIC II

• SELECT SundaySELECT Sunday

• National media personalitiesNational media personalities

• Minority Recruitment Enhancement GrantsMinority Recruitment Enhancement Grants

• Minority Recruitment Workshops Minority Recruitment Workshops

• Partnership with NBLIC IIPartnership with NBLIC II

• SELECT SundaySELECT Sunday

• National media personalitiesNational media personalities

Page 36: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Minority Recruitment Enhancement GrantsMinority Recruitment Enhancement Grants

• Competitive review processCompetitive review process• Recruit substantial number of minoritiesRecruit substantial number of minorities• 15 sites awarded grants (1 or 2 years)15 sites awarded grants (1 or 2 years)• Monthly reports – Monthly reports –

– Recruitment strategies implemented Recruitment strategies implemented – Simple success rating per strategySimple success rating per strategy

• MREGs supported additional recruitment MREGs supported additional recruitment and adherence materials and site staffand adherence materials and site staff

• Competitive review processCompetitive review process• Recruit substantial number of minoritiesRecruit substantial number of minorities• 15 sites awarded grants (1 or 2 years)15 sites awarded grants (1 or 2 years)• Monthly reports – Monthly reports –

– Recruitment strategies implemented Recruitment strategies implemented – Simple success rating per strategySimple success rating per strategy

• MREGs supported additional recruitment MREGs supported additional recruitment and adherence materials and site staffand adherence materials and site staff

Page 37: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Minority Recruitment Workshops

Minority Recruitment Workshops

• Three 1-day workshopsThree 1-day workshops– Round table discussions Round table discussions

• Sharing strategies, develop mentoring relationships and Sharing strategies, develop mentoring relationships and discuss problemsdiscuss problems

– Panel discussions with local community leaders and Panel discussions with local community leaders and SELECT Investigators SELECT Investigators

• Shared recruitment ideasShared recruitment ideas

– Disseminated workshop proceedings to all SELECT Disseminated workshop proceedings to all SELECT staff at the semi-annual SWOG/SELECT Workshopsstaff at the semi-annual SWOG/SELECT Workshops

• Three 1-day workshopsThree 1-day workshops– Round table discussions Round table discussions

• Sharing strategies, develop mentoring relationships and Sharing strategies, develop mentoring relationships and discuss problemsdiscuss problems

– Panel discussions with local community leaders and Panel discussions with local community leaders and SELECT Investigators SELECT Investigators

• Shared recruitment ideasShared recruitment ideas

– Disseminated workshop proceedings to all SELECT Disseminated workshop proceedings to all SELECT staff at the semi-annual SWOG/SELECT Workshopsstaff at the semi-annual SWOG/SELECT Workshops

Page 38: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Partnership with NBLIC IIPartnership with NBLIC II

• Minority outreach initiative of the NCIMinority outreach initiative of the NCI

• Innovative outreach strategies partnering Innovative outreach strategies partnering with the local SELECT siteswith the local SELECT sites– For Men Only retreats, Wellness on Wheels, For Men Only retreats, Wellness on Wheels,

and Taking it to the Top, and Taking it to the Top,

• Promotional items for events Promotional items for events – T-shirts, squeeze water bottles and caps with T-shirts, squeeze water bottles and caps with

the SELECT logothe SELECT logo

• Minority outreach initiative of the NCIMinority outreach initiative of the NCI

• Innovative outreach strategies partnering Innovative outreach strategies partnering with the local SELECT siteswith the local SELECT sites– For Men Only retreats, Wellness on Wheels, For Men Only retreats, Wellness on Wheels,

and Taking it to the Top, and Taking it to the Top,

• Promotional items for events Promotional items for events – T-shirts, squeeze water bottles and caps with T-shirts, squeeze water bottles and caps with

the SELECT logothe SELECT logo

Page 39: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT SundaySELECT Sunday

• Faith based, prostate education and Faith based, prostate education and SELECT recruitment initiative SELECT recruitment initiative

• Churches and Mosques in large cities Churches and Mosques in large cities

• Pastors delivered the information from the Pastors delivered the information from the pulpitpulpit

• Prostate cancer and SELECT enrollment Prostate cancer and SELECT enrollment information was distributed to membersinformation was distributed to members

• Faith based, prostate education and Faith based, prostate education and SELECT recruitment initiative SELECT recruitment initiative

• Churches and Mosques in large cities Churches and Mosques in large cities

• Pastors delivered the information from the Pastors delivered the information from the pulpitpulpit

• Prostate cancer and SELECT enrollment Prostate cancer and SELECT enrollment information was distributed to membersinformation was distributed to members

Page 40: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

National media personalitiesNational media personalities

• Les Brown - Television and radio personality, Les Brown - Television and radio personality, author and motivational speakerauthor and motivational speaker– Radio media tours, inroads to national programs, Radio media tours, inroads to national programs,

information on his websiteinformation on his website

• Ian Smith, MD – former medical correspondent Ian Smith, MD – former medical correspondent for NBC news network for NBC news network – NBC Nightly News program on the importance of NBC Nightly News program on the importance of

enrollment of minorities to clinical trials featuring a enrollment of minorities to clinical trials featuring a SELECT participant – September 2002SELECT participant – September 2002

• Les Brown - Television and radio personality, Les Brown - Television and radio personality, author and motivational speakerauthor and motivational speaker– Radio media tours, inroads to national programs, Radio media tours, inroads to national programs,

information on his websiteinformation on his website

• Ian Smith, MD – former medical correspondent Ian Smith, MD – former medical correspondent for NBC news network for NBC news network – NBC Nightly News program on the importance of NBC Nightly News program on the importance of

enrollment of minorities to clinical trials featuring a enrollment of minorities to clinical trials featuring a SELECT participant – September 2002SELECT participant – September 2002

Page 41: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Dr. Ike Powell and Mr. Les BrownPromote SELECT on a Radio TourDr. Ike Powell and Mr. Les BrownPromote SELECT on a Radio Tour

Page 42: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

SELECT Final AccrualSELECT Final Accrual

• National accrual goal of 32,400 was National accrual goal of 32,400 was reached 28 months earlier than projected!!reached 28 months earlier than projected!!

• Final accrual was 35,534Final accrual was 35,534• National accrual goal for African American National accrual goal for African American

men was 20%, actual was 15%men was 20%, actual was 15%• National accrual goals for Hispanic, and National accrual goals for Hispanic, and

Asian / Pacific Islander were 3% and 1%, Asian / Pacific Islander were 3% and 1%, actual were 6% and 1%actual were 6% and 1%

• National accrual goal of 32,400 was National accrual goal of 32,400 was reached 28 months earlier than projected!!reached 28 months earlier than projected!!

• Final accrual was 35,534Final accrual was 35,534• National accrual goal for African American National accrual goal for African American

men was 20%, actual was 15%men was 20%, actual was 15%• National accrual goals for Hispanic, and National accrual goals for Hispanic, and

Asian / Pacific Islander were 3% and 1%, Asian / Pacific Islander were 3% and 1%, actual were 6% and 1%actual were 6% and 1%

Page 43: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,
Page 44: Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair,

Minority Recruitment to SELECT

Elise D. Cook, MDAssociate Professor,Dept. of Clinical Cancer PreventionUT M. D. Anderson Cancer Center