Eliminating Barriers to Minority Participation in Clinical Trials

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Eliminating Barriers to Minority Participation in
Clinical Trials

• Debra Wujcik, RN, PhD
• Director Clinical Trials at Meharry
• Assistant Professor of Nursing

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History of Mistrust
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Background

• Approximately 20 of adult cancer patients are
  medically eligible for a cancer clinical trial.
• Less than 3 of adult cancer patients participate
  in a cancer clinical trials.
• Accrual is even less for minority and medically
  underserved populations.
• Studies show minority groups are as willing to
  participate as whites, but are less likely to be
  invited to participate.
• Those who participate in clinical trials are more
  likely to be insured and have higher
  socioeconomic status.

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Presentation Outline

• Cancer Clinical Trials Unit at Nashville General
  Hospital at Meharry
• ENACCT Community Partners Project

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Program Development

• 1998
• Nashville General Hospital moved to Meharry
  Medical College Campus
• 2000
• Research team formed at MMC under U54 Partnership
  grant
• 2003
• Minority Based Community Clinical Oncology
  Program Grant (MBCCOP)

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Assumptions

• Vanderbilt studies would be opened at NGH and
  accrual would begin.
• Minority and underserved persons dont want to
  participate in research.

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Identification of Barriers to Care and Clinical
Trial Participation

• Missed appointments.
• How does the patient enter the system?
• Who makes the appointments?
• Who reminds the patient?
• Missed communication.
• How does the physician know the pathology
  results?
• How does the patient find out?
• Missed rides.
• Does the patient have transportation?
• How reliable is the transportation?

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Identification of Barriers (cont.)

• Lack of insurance.
• Most patients present with no insurance
• Indigent
• Self pay on sliding scale and/or with discounts
• TN Care
• Lack of understanding.
• Assess what the patient knows/understands.
• Who influences patient? What do they
  know/understand?

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Procedure for Screening

• All patients diagnosed at MMC are evaluated for
  study eligibility.
• Cancer committee requested all patients with
  cancer be evaluated.
• Pathology reports are sent to research staff.
• Cases are identified and managed by the
  research team.
• Team reports progress through the system and
  arranges appointments and referrals as needed for
  diagnostic work up and staging.

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Clinical Trial Accrual Rates2001-2004
Year Screened Study Available Placed on study Total Accrual Rate Actual Accrual Rate
1 154 32 15 10 47
2 108 38 17 16 45
3 145 44 27 19 43
4 162 50 36 22 44
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Reasons patients did not go on study (2001-2004)

• Co-morbidity 19 27
• Eligibility 17 23
• Performance status 12 17
• Refused treatment 8 11
• Dept of corrections 5 7
• Refused research 3 4
• Refused specific trial 3 4
• Returned to local MD 2 3
• Insurance 1 1
• Lost to follow up 1 1
• Transportation 1 1
• 72

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Cases are identified and managed by the research
team

• Every patient is identified and screened.
• Pathology reports are reviewed.
• Abnormal screening results are reviewed.
• Information is entered into a database for review
  at weekly research team meeting.
• Patients are navigated through the system using
• Nurse navigator
• Research nurse

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Model of Care Refined

• Every patient is identified and screened.
• Pathology reports are reviewed.
• Abnormal screening results are reviewed.
• Information is entered into a database for review
  at weekly research team meeting.
• Patients are navigated through the system using
• Nurse navigator
• Research nurse

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Model of Care Refined (cont.)

• Physician is advised if a clinical trial
  available.
• A plan to address obstacles such as
  transportation or medications is developed.
• Clinical trial option is offered during initial
  treatment discussion.
• Clinical trial is not an afterthought.
• Patient is not referred elsewhere for clinical
  trial participation.

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Screened Patients
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Screened Patients
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Screened Patients
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All Patients on Study 2005-2008
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All Patients on Study 2005-2008
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Clinical Trial Accrual Rates
Year Screened Study Available Placed on study Total Accrual Rate Actual Accrual Rate
1 154 32 15 10 47
2 108 38 17 16 45
3 145 44 27 19 43
4 162 50 36 22 44
5 138 29 19 14 66
6 184 59 53 29 90
7 234 91 66 28 73
Ave 21 68
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Outcome of Screened Patients 2005-2007
Study available, pt. eligible Study available, pt. eligible Study available, pt. eligible 33  
  On study 30.0
  Refused research Refused research 2.5
  Treat off study Treat off study 0.5
Study available, pt not eligible Study available, pt not eligible Study available, pt not eligible 5  
  Treat off study Treat off study 4.5
  No treatment offered No treatment offered 0.5
Study not applicable Study not applicable 8  
  Treat off study Treat off study 7.0
  No treatment offered No treatment offered 1.0
Study not available Study not available 50  
  Treat off study Treat off study 46.5
  No treatment offered No treatment offered 3.5
Refused Treatment Refused Treatment   3  
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• Wujcik, D Wolff, SN. (2010). Recruitment of
  African Americans to national oncology clinical
  trials through a clinical trials shared resource.
  Journal of Health Care for the Poor and
  Underserved, 21 37-52.

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Summary

• Racial/ethnic minority and underinsured patients
  are willing to participate in cancer clinical
  trials.
• A team approach and case management (navigation)
  strategies ensure success.
• A proactive rather than reactive approach is
  needed.

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ENACCT Implementation Partners Project

• Education Network to Advance Cancer Clinical
  Trials

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• The only national organization solely devoted to
  community-centered approaches to cancer clinical
  trials education.
• Dedicated to finding evidence based approaches
  that work to change attitudes, behaviors and
  ultimately, accrual.
• http//www.enacct.org/

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Goals of Implementation Partners Project

• To increase knowledge and improve attitudes about
  clinical trials among minority and underserved
  populations in Nashville, TN.
• To identify community concerns and opportunities
  regarding clinical trials participation and make
  recommendations for future collaborations and
  interventions.
• To identify community members interested in
  participating in ongoing initiatives.

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Objectives

• Engage participants in discussion to identify
  common concerns and opportunities
• Host six town hall meetings with guided
  discussion format
• Show participants informational DVD.
• Identify at least 6 community members interested
  in participating in ongoing initiatives such as
  advisory board members, IRB members, or community
  advocates

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Organizational Partners

• Vanderbilt Ingram Cancer Center
• Meharry-Vanderbilt-Tennessee State University
  Cancer Research Partnership
• Clinical Trials Shared Resources
• VICC CTSR
• MMC/VICC Partnership CTSR
• Tennessee Comprehensive Cancer Control Coalition
  Middle TN Region

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Community Partners

• Nashville Branch of the NAACP Health Committee
• Cervical Cancer Coalition of Tennessee
• Nashville Health Disparities Coalition
• Nashville Latino Health Coalition
• Super 60s of NGH
• Dickson Community Health Council

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Town Hall Meetings

• Sponsored by community partner
• Target 20 participants
• Agenda
• Welcome and snacks
• Educational DVD and print materials
• Focused discussion, recorded for later
  transcription
• Medical hero

• Babysitting provided as needed
• Participants receive 25 gift card

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Demographic Data

• Attendance
• Participants 96
• F/U Volunteers 49
• Gender
• Male 23
• Female 75
• Education
• Less than HS 3
• Some HS 6
• HS Graduate 33
• College 39

• Average age 49
• Race
• White, Non Hispanic 7
• White, Hispanic 11
• Black 76
• Other 2
• Research Exp
• Yes 32
• Positive 23
• Negative 0
• Neutral 3
• No 64

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In their own words.

• What is your experience with cancer
• Its just amazing how fast it kills
• I wanted to come today to say that I want to be
  a part of whatever I can to stop families from
  going through that
• Men need to be teaching their families

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In their own words.

• When you hear the word cancer, what comes to
  mind?
• The first thought that comes to mind is fight
• I think about the connection between healing and
  spirituality
• What comes to mind is what type, what stage, and
  what can be done because I know theres hope

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In their own words.

• What comes to mind when you hear the word
  research?
• We definitely need to get African American
  people involved
• First thing I do is question the validity and
  then I question me doing it, and then I want to
  see somebody that looks like me doing it
• we still need to be careful about whos doing
  the research

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In their own words.

• When you hear the word research.
• When we talk about the research, you can go back
  to Tuskegee and you have to remember, okay, the
  same people who were being asked to trust with
  our lives now, in research projects, are the same
  people who, you know, did this in Tuskegee
• Once you figure out a treatment, am I going to
  be able to afford it? Is it going to be
  available to me? Is it going to be available to
  people like me?

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In their own words.

• What would motivate you to participate?
• Letting people know that we are furthering
  progress in treating something by the research
• One of the main motivators in neighborhoods like
  where I come from is moneyMoney you know is the
  motivator and the thing is, there are people who
  are desperate enough in this time, black, white,
  whatever, but impoverished, who are going to say,
  you know what I need that 20
• The relationship with the primary physician

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In their own words.

• What keeps you from participating?
• Its the way it is presented it is very
  intimidating and its overwhelming
• A lot of times its the language thats used
  because a lot times its lay people, its elderly
  people who dont have a clue about the basic
  diagnosis, let alone a clinical trial
• A lot of people cant read
• You know you need to be there, but due to the
  fact that youre illiterate, the fact that you
  cannot understand, youre not going to
  participate.

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In their own words.

• What are thoughts about the video?
• It makes you want to sign up
• It was a good video. But lets not forget the
  fact that what this is, is basically targeted
  recruitment you see what I am saying? And in
  recruitment, you have to look further than what
  youre presented
• As a people, especially African-American people,
  we need to be embraced, we need to be loved.
• I feel we are seen and we are heard

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Next Steps

• Share findings with an advisory board made up of
  THM participants
• Did we hear you correctly?
• How can we use this information to change and
  improve the way we conduct our research?
• Further engagement
• Individual interviews exploring mistrust and fear
• Train the trainer project
• IRB training

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Questions?