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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, PADepartment of Biomedical Informatics, University of Pittsburgh, Pittsburgh, PA

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Overview

• 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 cancerOver 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– Lack of awareness of trials

– Fears and misconceptions

Information

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Previous Approaches to Information Provision

• 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

• 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– 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– 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

“…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)

• Reaction to concept positive in the group unfamiliar with cancer and clinical trials

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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 self-serving. 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?” (G1-p18)

– “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 • Anne R. Humphreys• Janice L. Dreshman• Maryanne Murry• Robin E. Connors• Loretta Leriotis