1. DISCUSSING CLINICAL TRIALS THE “S-A-F-E-R” APPROACH ROBERT BUCKMAN M.D.,PhD. PRINCESS MARGARET HOSPITAL UNIVERSITY OF TORONTO

2. DISCUSSING CLINICAL TRIALS S-A-F-E-R Clinical trials appear to be: To the patient: Complicated, mysterious & scary To us: Straightforward and routine with recruitment being a major goal

3. DISCUSSING CLINICAL TRIALS S-A-F-E-R It’s probably the umpteenth time we’ve said it…. But it’s the first time they’ve heard it (So how do we make it sound fresh?)

4. DISCUSSING CLINICAL TRIALS S-A-F-E-R So what goes wrong? The “dark matter” of the interview We can easily make the dark matter “visible”

5. DISCUSSING CLINICAL TRIALS S-A-F-E-R There’s a difference between PROCESS and OUTCOME: GOOD PROCESS REQUIRES RESPONSE TO CHANGE = SENSITIVITY = ACKNOWLEDGEMENT OF EMOTIONAL COMPONENT OF INTERACTION

6. DISCUSSING CLINICAL TRIALS S-A-F-E-R S – SETTING & STARTING A – AGENDA F – FACTS at the same time as E – ENQUIRIES & EMOTIONS R – REINFORCERS & WRAP-UP

7. DISCUSSING CLINICAL TRIALS S-A-F-E-R S – SETTING & STARTING 1. SETTING 2. GREETING 3. ENGAGING

8. DISCUSSING CLINICAL TRIALS S-A-F-E-R A – AGENDA The agenda should be the first item on the agenda. “Tell them what you’re going to tell them”

9. DISCUSSING CLINICAL TRIALS S-A-F-E-R F – FACTS  MAKE A CONSCIOUS EFFORT TO TRANSLATE MEDSPEAK INTO PLAIN LANGUAGE  GIVE INFO IN SMALL CHUNKS  CHECK RECEPTION  RESPOND TO EMOTIONS AS THEY ARISE

10. DISCUSSING CLINICAL TRIALS S-A-F-E-R E – EMOTIONS & ENQUIRIES The three-step Empathic Response is the easiest way of acknowledging emotions

11. DISCUSSING CLINICAL TRIALS S-A-F-E-R  ACKNOWLEDGING EMOTIONS: The Empathic Response  Identify the emotion (theirs or yours)  Identify the source of the emotion  Respond in a way that shows you have made that connection T You don’t have to feel the emotion yourself T You don’t have to agree with the viewpoint

12. DISCUSSING CLINICAL TRIALS S-A-F-E-R  E-V-E The key to addressing emotions Each response should be one of these  EXPLORING  VALIDATING  E MPATHIC

13. DISCUSSING CLINICAL TRIALS S-A-F-E-R R – R EINFORCERS & W R AP-UP REINFORCERS & WRAP-UP Reminders (or aides-memoire) can be JOTTED NOTES, BROCHURES, AN AUDIO TAPE (patient’s or yours) AND A FRIEND OR RELATIVE!

14. DISCUSSING CLINICAL TRIALS S-A-F-E-R The bottom line:  Make it interactive  Translate Medspeak into plain language  Acknowledge all emotions (including uncertainty)  Don’t be afraid of saying “I don’t know”  Give reinforcement at end

15. DISCUSSING CLINICAL TRIALS S-A-F-E-R The S-A-F-E-R way is the better way

16. DISCUSSING CLINICAL TRIALS S-A-F-E-R