Improving Participation in Oncology Research Trials IMPORT

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Improving Participation in Oncology Research
Trials (IMPORT)

• Mollie W. Howerton, PhD, MPH
• Instructor, Department of Oncology
• Johns Hopkins School of Medicine

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Todays Objectives

• Provide overview of evidence on clinical trial
  accrual from systematic review
• Present IMPORT study design
• Discuss preliminary results of IMPORT study
• Compare IMPORT results with results of systematic
  review

The Office of Recruitment and Retention Lunch
Lecture Series May 15, 2009
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Background

• 1993 NIH Revitalization Act called for inclusion
  of women minorities in all human subjects
  research
• NCI budget nearly doubled from 1993 to 2002
• Trial accrual increased
• Not clear if all populations benefited
• Some populations remain under-represented in
  NCI-funded clinical trials

The Office of Recruitment and Retention Lunch
Lecture Series May 15, 2009
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Key Questions

• What are barriers promoters for participation
  of underrepresented populations in cancer trials?
• What effects do healthcare providers have on
  recruitment of under-represented populations?
• What recruitment strategies are efficacious?
• What measures of recruitment success have been
  used?
• What methods have been used to study recruitment
  strategies?

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Systematic Review
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Conceptual Framework
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Results Barriers to Promoters of Enrollment

• Key Findings from 66 studies

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Study Characteristics

• Target group
• Patients / Participants 38
• Physicians 11
• Researchers 3
• Type of trial
• Therapeutic 34
• Prevention 16
• Actual accrual vs. behavioral intention
• Accrual 21
• Intention 16

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Lecture Series May 15, 2009
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Study Characteristics (II)

• Type of population
• African-American 27
• Older adults 14
• Latino/Hispanic 6
• Asian/Pacific Islander 2
• Native American / Alaskan Native 4
• Adolescent 3
• Rural 2
• US-based 40

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Most Frequently Reported Barriers

• Mistrust of research medical system (n 17)
• Perceived harms (n 11)
• Lack of education about clinical trials (n 10)
• Availability of transportation (n 9)
• Time commitment required (n 8)
• Mistrust of researchers (n 6)

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Barriers to Awareness(N 15 studies)
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Barriers to Opportunity(N 35 studies)
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Barriers to Acceptance(N 23 studies)
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Most Frequently Reported Promoters

• Perceived benefits of trial participation (n 7)
• Patient incentives (n 6)
• Altruism (n 6)
• Culturally relevant education about trials (n
  4)
• Provider incentives (n 3)

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Other Key Findings onBarriers Promoters

• Available evidence mostly about accrual to
  therapeutic trials
• Barriers to opportunity frequently reported for
  both prevention treatment trials
• Limited data on Latinos/Hispanics, Asian/Pacific
  Islanders, American Indians/Alaska Natives, older
  adults, adolescents
• Barriers differed across populations

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Any questions so far?
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Results Provider Roles in Recruitment

• Key Findings from 18 studies

Source Howerton et al,. Provider Roles in the
recruitment of underrepresented populations to
cancer clinical trials. Cancer. 2007 109(3)
465-476.
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Studies Reporting on Provider Barriers to- and
Promoters of Clinical Trial Enrollment
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Studies Reporting on Provider Attitudes as
Barriers to Clinical Trial Enrollment (n15)
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Studies Reporting on Provider Promoters to
Clinical Trial Enrollment (n7)
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Provider Roles in Opportunity
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Studies Reporting on Study Design Barriers (n11)
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Acknowledgements

• NCI
• Jon Kerner, Ph.D.
• Vickie Shavers, Ph.D.
• Worta McCaskill-Stevens,PhD
• Ted Trimble, MD
• Leslie Ford, MD
• Cynthia Vinson
• Michaele Christian, MD
• AHRQ
• Captain Ernestine Murray

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The EPC Team
Principal Investigators Jean G. Ford, MD Mollie
W. Howerton, PhD, MPH Co-Investigators Tiffany
L. Gary, PhD, Gabriel Y. Lai, MHS. Shari Bolen,
MD, MPH, Jon Tilburt, MD M. Chris Gibbons, MD,
MPH, Charles Baffi, PhD, MPH Renee F. Wilson, MS,
Carolyn J. Feuerstein Peter Tanpitukpongse, Neil
R. Powe, MD, MPH, MBA Eric B. Bass, MD, MPH
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Any Questions?
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Improving Participation in Oncology Research
Trials (IMPORT)
Follow up study

• Preliminary Findings

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Hypothesis

• Sociodemographic, cultural, psychosocial, and
  geographic, institutional-, and community-level
  factors influence cancer clinical trial
  awareness, opportunity and acceptance/refusal.

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Questions

• What are the predictors of participation in
  cancer treatment trials at the SKCCC?
• Residents of the Greater Baltimore Area
• Currently receiving treatment or intend to
  receive their treatment for cancer at the SKCCC
• Do these predictors vary by race/ethnicity,
  cultural factors, and/or distance from the
  Center?

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Conceptual Framework
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IMPORT Protocol
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Specific Aims

• Aim 1
• Conduct interviews with individuals diagnosed
  with cancer, who are being treated at the SKCCC.
• Aim 2
• Analyze barriers to- and promoters of
  opportunities to participate in cancer
  therapeutic trials.

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Inclusion criteria

• Ages of 18 and older.
• Currently undergoing treatment at the SKCCC, or
  considering a treatment plan
• Residence in the Greater Baltimore area
  (Baltimore City and Baltimore County)
• Ability to speak English
• Ability to provide informed consent.

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IMPORT Protocol in Tabular Form
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Questionnaire

• Awareness
• 9 questions on cancer knowledge
• 1 question about knowledge of CTs
• Opportunity
• 1 question about opportunity to participate in a
  CT at the Cancer Center
• Decision to Accept/Refuse Participation
• Attitudes about clinical trials
• Clinical trials (CT) are an experiment on
  people
• People who participate in CTs are guinea pigs
• A CTis a way of collecting more information about
  a therapy
• People benefit from participating in a CT
• You would benefit if you participated in a CT

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Results
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Characteristics of Study Population (n67)

• 76 African Americans (n51) 24 Caucasians
  (n16)
• 55 Male
• 30 Married

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Reasons for not participating in a CT

• Cost
• Transportation
• Negative beliefs about research
• Not interested
• Too sick to travel
• Time
• Side-effects from medication
• Religious beliefs

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Reasons for participating in a CT

• Health benefits for self
• Health benefits for others
• Financial benefits for self
• Support for other patients
• Recommendations from doctor
• Only treatment option

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Ongoing Initiatives andFuture Directions

• Develop evidence-based strategies
• Complete IMPORT (IMproving Participation in
  Oncology Research Trials) data analysis
• Start IMPORT II
• Test efficacy of promising recruitment methods
• Health Care System Focus
• Implement/evaluate patient navigation as a
  strategy
• Patient Focus
• Culturally targeted/ tailored education
  strategies
• Special attention to African American men
• Provider/ Research Team Focus
• Educational interventions directed to clinicians,
  investigators and research managers

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Questions?
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Thank you for attending!

• The Office of Recruitment and Retention, ICTR
• 14 May 2009, 2nd lunch time lecture series
• Please let us know of any topics you would like
• to have addressed, or if you would a copy of
• todays presentation
• Mjenckes_at_jhmi.edu