Download View Slide Presentation - Association for Pathology Informatics

Creating a Synthetic Interview
for Patients Considering
Cancer Clinical Trials
Valerie Monaco, Beth Simon, Suzanne Pozzani,
Kenneth McCarty & Samuel Jacobs
University of Pittsburgh Cancer Institute, Pittsburgh, PA
Department of Biomedical Informatics,
University of Pittsburgh, Pittsburgh, PA
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Overview
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Motivation for Project
Description of Synthetic Interview
Research Questions
Focus Group Findings
Next Steps
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Cancer Clinical Trials
It normally takes seven years to complete the
three phases of cancer clinical trials needed to
test a new treatment. In the next seven years…
Over 1 million individuals will die from lung cancer
Over 350,000 will die from colon and rectal cancer
Over 270,000 will die from breast cancer
Only 2-3% of adult oncology patients currently
participate in cancer clinical trials.
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Many Barriers to Participation
• Physician Barriers
– Disinterest in clinical trials
– Lack of awareness of trials
– Lack of access to trials due to restrictive regulatory
requirements
– Lack of staffing resources to complete trial
• Patient Barriers
Information
– Lack of awareness of trials
– Fears and misconceptions
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Previous Approaches to
Information Provision
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Leaflets
Brochures
Booklets
Tape-recorded information
Hypercard software application
Video modeling
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Previous Findings
• Finding have been mixed
– Only some studies have found that these
interventions result in increased knowledge
about trials
– No study has shown an effect on the
willingness to join a hypothetical trial
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Limitations to Previous Approaches
• Information scope
– e.g., short booklets
• Access
– only viewed one time in evaluation study
• Media format
– text only
– video only
• Content
– material presents facts about trials but not patient
experiences
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What do patients want?
A recent interview study with patients who had declined to participate in a
clinical trial found that these patients reported having
“high levels of information need”
and wanted
“a more gradual introduction to the
research process, with shorter pieces of
information being given over a longer period.”
Stevens T, Ahmedzai S. Why do breast cancer patients decline entry into randomised trials and how do they feel
about their decision later: A prospective, longitudinal, in-depth interview study. Patient Education and Counseling
2004;52:341-348
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Our Approach
• Synthetic Interview™ (SI)
– First developed at Carnegie Mellon University
– Product available via MedRespond
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Windows Server 2003
Streaming Media Server
SQL Database
.NET Framework
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Our Approach
• Synthetic Interview
– Backend: a catalog of video clips
– Web site: users type in questions
– Software: matches question to appropriate
answer and video clip
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Version 2.0 – www.medrespond.com/clinicaltrials
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Version 2.0 – www.medrespond.com/clinicaltrials
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Version 2.0 – www.medrespond.com/clinicaltrials
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Addressing Previous Limitations
• Information scope
– Our SI has over 200 question/answer pairs
• Access
– Available 24/7 via the Internet
• Media format
– Provides video and text-based responses
– Interview can be printed for future sharing and review
• Content
– Expert information PLUS clips with clinical trial
participants
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Formative Evaluation Focus Groups
• Research Questions
– How well will this tool meet the needs of
consumers?
– What can we improve on before its release?
• Two focus groups
– Group 1: Hospital volunteers and members of a
breast cancer support group
– Group 2: Customers of an in-home nail care
salon
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Participants
Group 1
• 8 women
• Average age: 56 (41-73)
• Level of Education
– High School: 1
– Post-secondary/College: 4
– Post-College: 3
• Internet Usage
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Never: 1
Occasionally: 1
Frequently: 2
Everyday: 4
Group 2
• 7 women
• Average age: 54 (42-67)
• Level of Education
– High School: 0
– Post-secondary/College: 6
– Post-College: 1
• Internet Usage
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Never: 1
Occasionally: 0
Frequently: 2
Everyday: 4
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Participants
Group 1
• 6 women had history of breast
cancer
• 3 women had been enrolled in
a clinical trial
Group 2
• None had history of
cancer
• None had been in enrolled
in a clinical trial
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Focus Group Structure
– What comes to mind when you hear the phrase “clinical trial”?
– Write down questions you would have if a doctor suggested
participation in a clinical trial to you.
– Write down questions you would ask a patient that had
participated in a clinical trial.
– Discussion and voting procedure
– Demonstration of tool with questions generated by group
– What would it take for this product to get a gold star?
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Focus Group Questions
– What comes to mind when you hear the phrase “clinical trial”?
– Write down questions you would have if a doctor suggested
participation a clinical trial to you
– Write down questions you ask a patient that had participated in
a clinical trial.
– Discussion and voting procedure
– Demonstration of tool with questions generated by group
– What would it take for this product to get a gold star?
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Data Analysis
• Post session debriefing with co-investigators
• Sessions were transcribed
• Transcripts reviewed for themes
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Focus Group Findings
• Key findings
– Reaction to concept generally positive
– Some participants indicated that they were
learning things from the interview
– Language is important
– Poor matches may lead to disengagement
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Key Findings
• Reaction to concept positive in the group
unfamiliar with cancer and clinical trials
“…privacy…
…wouldn’t mind asking questions…
…you’re not wasting anyone’s time.” -G2-p9
“…don’t have to feel like your question’s
dumb…
…“I don’t want to waste the doctor’s
time, they’re busy.” I think this is
wonderful.” (2-9)
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Key Findings
• But it is not for everyone…
“the fact that somebody is saying
that to me via a video is
meaningless to me.” (1-28)
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Key Findings
• While listening to answers, participants
unfamiliar with clinical trials indicated that
they were learning new information.
“…I didn’t know that…. I thought you
just made up whatever trial…and just
tested on people… I didn’t know they
were under government scrutiny.” (G2-p5)
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Key Findings
• Language used in the answer is important
“I found some of his answers a little selfserving. If you’re coming at it from a
strictly skeptical point of view.” (G1-p13)
“It’s [patient privacy] guaranteed at
all times? How are they going to
control staff so that they can
guarantee it? (G1-p20)
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Key Findings
• Wrong answers elicit strong response
– How would a clinical trial affect my current treatment?
SI: “Your doctor must review a list of all your
medications, including prescribed, over-the-counter
medicines, vitamins, and herbal remedies. Sometimes
these medications are not permitted during cancer
therapies because they may interfere with the therapy
effectiveness or have dangerous interactions.”
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Key Findings
• Wrong answers elicit strong response
– How would a clinical trial affect my current treatment?
– “Not really what we wanted to know, Marianne.”…It
didn’t answer our question at all! (G1-p16)
– “Let’s give her another chance” (G1-p17)
– How would a clinical trial affect my current cancer
treatment?
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Key Findings
• Wrong answers elicit strong response
– How would a clinical trial affect my current treatment?
– “Not really what we wanted to know, Marianne.”…It didn’t
answer our question at all! (G1-p16)
– “Let’s give her another chance” (G1-p17)
– How would a clinical trial affect my current cancer treatment?
– Same answer – lots of laughter.
– “See, and if I was a first-time user and that happened to me, I’d
be pissed. I’d be, “I’m stupid………why am I doing this?” (G1p18)
– “I’d give her two questions. But in real life, I’d never give her
three.” (G1-p18)
– “I would think, “Forget it. They’re not going to be able to
answer my questions” (G1-p18)
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Changes to Synthetic Interview
• Editing existing answer text with assistance
from advisory board
• Reconfiguring interface to avoid
question/answer mismatches that can occur
• Including additional patient clips
• Planning additional focus groups
• Releasing Version 3.0 in Fall 2006
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Focus Group Limitations
• Small number of focus groups
• Some findings may not have been elicited
given the structure prepared by researchers
• Doesn’t answer questions related to the
usability of and the impact of the synthetic
interview.
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Next Evaluation Step
• Received Grant from Komen Foundation
• Goal: to evaluate the impact of the SI on
clinical trial knowledge, attitudes,
decisional conflict, decision satisfaction,
and accrual rates in breast cancer patients
eligible for adjuvant therapy clinical trials
• May 2006 to April 2008
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Acknowledgements
• This work was supported by a grant from the
National Cancer Institute (R21CA101721).
• Patients and physicians who have contributed to
Synthetic Interview
• Advisory Board members
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Anne R. Humphreys
Janice L. Dreshman
Maryanne Murry
Robin E. Connors
Loretta Leriotis
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