Suggestions for Presenting Trial Schema

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ASCO/AACR Methods in Clinical Cancer Research
Workshop July 30 August 5, 2011 Vail Marriott
Mountain Resort Vail, CO
From Informed Consent to Informed Choice Based on
Workgroup 6Clinical Trials Summithttp//www.canc
ersummit.org/
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Informed Consent to Informed Choice
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Topics

• Patient Friendly Informed Consent Documents
• Patient Friendly Informed Consent Process
• Patient Advocates
• Improving Patient Compliance

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Patient Friendly Informed Consent Documents

• Use plain English at the 8th grade level (can be
  checked in MS WORD)
• Dont use jargon or acronyms
• Use attractive, well-organized layout
• Lots of white space
• Pictures and tables
• Different fonts, styles, boxing for emphasis
• Bullet list
• Check our websites hotlinked in the Web_Links
  recourse on your memory stick

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Patient Friendly Informed Consent Documents

• Clearly distinguish between standard and
  experimental therapy
• Treatments
• Tests
• Side effect
• When describing side effects indicate
• How likely they are
• How severe, including whether or not they are
  life threatening, they are likely to be
• What can be done to minimize them and how
  effective these options are
• Whether they will resolve once treatment ends

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Use Schemas and Schedules

• Trial schemas/flowcharts in Informed Consent
  Documents are sometimes helpful, especially in
  Phase II and III trials
• Patient schedules in picture and/or table format
  are always helpful
• Clearly distinguish between standard of care
  versus experimental procedures and treatments

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Phase II III Patient Schedule

• Use a time line
• Use shading to distinguish between standard of
  care and investigational interventions
• Present treatments above the line and diagnostic
  tests below the line
• Use plain English in a version you will provide
  the patient (schedule)
• Use medical jargon/abbreviation in a version you
  will use for your protocol
• If the trial is long, consider one chart or table
  showing days within a treatment cycle and a
  second showing weeks (or months) of the study and
  tests per week (or month)

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Clinical Trial Patient Time Flow
TREATMENT
Ex
Ex
Ex
Ex
Ex
Std
Std
Std
Week
4
8
12
16
0
DIAGNOSTIC
Blood
Blood
Std
Physical CT Blood Biopsy
Physical CT Blood Biopsy
Experimental
Standard of care
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Example of Potential Side Effects
Bold Type indicates side effects that may be
permanent, serious or fatal Italics
Type Indicates side effects that are generally
resolved with additional drugs Plain Type
indicates other known side effects
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Topics

• Patient Friendly Informed Consent Documents
• Patient Friendly Informed Consent Process
• Patient Advocates
• Improving Patient Compliance

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Patients

• Are All the Same

• Each is Unique

• Overwhelmed
• Emotional traumatized
• Cognitively compromised

• Understanding of cancer treatment and treatment
  trials
• Information needs, cognitive style
• Methods of coping
• Family and financial situation
• Age, ethnicity, job status

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Ways to Compensate for Patients Distressed State

• Validate patients emotions
• Slow down
• Engage others
• Ask about patients emotional state, needs,
  feelings
• Ask about patients cognitive state, needs,
  preferences
• Require patient to paraphrase, using their own
  words
• Continually solicit feedback and questions from
  patients and adjust accordingly
• Use multiple formatswords, pictures, diagrams,
  models
• Give patient take away material and follow-up
  phone numbers

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Improving the Consent Discussion

• Getting Starting

Closing
Patient Interaction

• Prepare yourself for the meeting, including
  emotionally
• 5 questions to ask your patient
• Empathize with the patients predicament

• Close with discussion of next steps
• Provide patient with take-homes

• Ask the patient to explain the situation
• Build on what the patient has told you
• Ask the patient about her questions concerns
• Respond to each of the patients issues, one by
  one
• Have the patient paraphrase your responses to
  ensure understanding
• Raise critical issues that the patient has not
  raised

Adapted from CISN (http//cisncancer.org/)
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Five Questions to Help Personalize the Consent
Process

• How much does this patient already understand
  about her condition and options?
• How much does this patient want to know about her
  condition and options? (e.g., Is she a blinder
  or monitor?)
• What are the issues that will be most important
  to this patient?
• What are the best ways to help this patient
  understand what she wants/needs to understand?
• What additional support can I offer to this
  patient?

Adapted from CISN (http//cisncancer.org/)
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• 1. How much does this patient already understand
  about her condition and options?

• Start by asking the patient to explain how she
  understand her diagnosis and treatment options
• Depending on her answer, cover the topics she
  needs, in the following order
• Her diagnosis
• Standard of care
• What a clinical trial is
• How participating in this trial would be
  different from standard of care

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• 2. How much does this patient want to know about
  her condition and options?

• Some patients want to know everything, including
  statistics
• Cover key concepts first, but let them know how
  to access more information
• Some patients do not want much information
• Go over the most critical concepts only
• Some patients do not want to know anything they
  want their doctor to decide
• The decision needs to be the patient, and be
  based on understanding their options
• You must be sure they understand the pros and
  cons of participating

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• 3. What are the issues that will be of most
  important to this patient?

• Survival
• Getting through treatmente.g., side effects
• Family issues
• Job issues
• Logistics, travel
• Insurance and/or other financial concerns
• Complementary and/or alternative treatments
• Other

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4. What are the best ways to help this patient
understand what she wants/needs to understand?

• Be sensitive to the patients culture
• Involve a significant other or translator
• Use analogies and metaphors
• Provide or avoid mentioning statistics
• Providing pictures, flow charts, plus/minus table
• Providing take homes (e.g., brochures, DVD)
• Other
•  

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• 5. What additional support can I offer to this
  patient?

• Psychology referral
• Social worker referral
• Patient navigator referral
• Clergy referral
• Access to another patients
• Local support groups
• Other

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Topics

• Patient Friendly Informed Consent Documents
• Patient Friendly Informed Consent Process
• Patient Advocates
• Improving Patient Compliance

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How Patient Advocates Can Help You

• Reviewing, protocol, informed consent, patient
  information
• Patient recruitment, retention, and support
• Community outreach, public relations
• Finding funding
• Public policy
• Etc.

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Finding Patient Advocates

• At Your Hospital
• Outreach
• Communications
• Support Groups
• Social Workers

• In the Community
• Other patients
• Advocacy Organizations
• ACS Chapter
• Health fairs, health writers, etc.
• Community groups, churches

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Topics

• Patient Friendly Informed Consent Documents
• Patient Friendly Informed Consent Process
• Patient Advocates
• Improving Patient Compliance

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Improving Patient Compliance

• Make sure patients understand what is required
  ask them to repeat what you said.
• Provide patients with written instructions that
  are easy to follow.
• Provide patients with a telephone number to call
  if they have questions.
• Have someone proactively call to check-in with
  patients.
• Have patients maintain treatment diaries and
  review them.
• Consider using medicine boxes for oral
  medications.
• Consider using peer counselors