1. The EPEC-O Curriculum is produced by the EPEC TM Project with major funding provided by NCI, with supplemental funding provided by the Lance Armstrong Foundation. Education in Palliative and End-of-life Care - Oncology The Project EPEC-O TM

2. EPECEPECOOEPECEPECOOO EPECEPECOOEPECEPECOOO Module 10 Clinical Trials Module 10 Clinical Trials EPEC - Oncology Education in Palliative and End-of-life Care - Oncology

3. Objectives l Describe the reasons why patients participate in clinical trials l Describe the opportunities for patients in phase 1 clinical trials l Discuss phase 1 clinical trials with patients and families using a 7-step protocol l Describe the reasons why patients participate in clinical trials l Describe the opportunities for patients in phase 1 clinical trials l Discuss phase 1 clinical trials with patients and families using a 7-step protocol

4. Video

5. Low participation rate in clinical trials l Too few trials l Restrictive eligibility criteria l Physicians don’t offer trials l Patients refuse participation l Too few trials l Restrictive eligibility criteria l Physicians don’t offer trials l Patients refuse participation Joffe S, et al. Lancet. 2001.

6. Why patients enroll in trials l Hope for response l Recognize small chance for benefit l Patients as ‘fighters’ l Realistic not nihilistic l Hope for response l Recognize small chance for benefit l Patients as ‘fighters’ l Realistic not nihilistic Meropol NJ, et al. J Clin Oncol. 2003.

7. Palliative care or phase I trial l Most phase I consents offer palliative care as alternative treatment l Patients aware of choices l Phase I plus palliative care l Change in risks New agents may have less toxicity l Most phase I consents offer palliative care as alternative treatment l Patients aware of choices l Phase I plus palliative care l Change in risks New agents may have less toxicity Hornig S, et al. N Engl J Med. 2002.

8. Opportunities in clinical trials l Offer clinical trials l Identify ‘fighters’ l Honest presentation of phase I trials l Phase I and symptom management l Offer clinical trials l Identify ‘fighters’ l Honest presentation of phase I trials l Phase I and symptom management

9. Informed consent l Nature of the trial, what will it involve for the patient l Risks: Common, rare but consequential l Ensure patient’s insight and rational reasoning l Nature of the trial, what will it involve for the patient l Risks: Common, rare but consequential l Ensure patient’s insight and rational reasoning

10. Research on palliative interventions l Which patients should be enrolled? l Refractory symptoms l Prior intolerable side effects l Substitute / supplement conventional options l Which patients should be enrolled? l Refractory symptoms l Prior intolerable side effects l Substitute / supplement conventional options

11. Conflicts of interest l Clinician role trumps investigator role l Incentives Financial, career advancement, research progress versus patient best interests l Tell the patient your role in the trial, if any l Clinician role trumps investigator role l Incentives Financial, career advancement, research progress versus patient best interests l Tell the patient your role in the trial, if any

12. Discussing phase I trials 7-step protocol... 1.Set the stage 2.Determine what the patient / family know 3.How much does the patient want to know – enough for informed consent? 1.Set the stage 2.Determine what the patient / family know 3.How much does the patient want to know – enough for informed consent?

13. ... 7-step protocol 4.Discuss the patient’s situation and the potential clinical trial Informed consent discussion if applicable 5.Respond to emotions 6.Plan next steps and follow up 7.Review and revise periodically 4.Discuss the patient’s situation and the potential clinical trial Informed consent discussion if applicable 5.Respond to emotions 6.Plan next steps and follow up 7.Review and revise periodically

14. Step 1: Set the stage l Plan what you will say l Familiarize yourself with The patient’s diagnoses, prognosis, treatment experience The protocol l Determine who else should be present l Plan what you will say l Familiarize yourself with The patient’s diagnoses, prognosis, treatment experience The protocol l Determine who else should be present

15. Step 2: Determine what the patient / family know? l Knowledge of disease status l Treatment expectations l Phase I trials l Knowledge of disease status l Treatment expectations l Phase I trials

16. Step 3: How much does the patient want to know? l Identify patient preferences for information l Knowing the ‘truth’ l Will the patient’s information preferences allow for informed consent? l Identify patient preferences for information l Knowing the ‘truth’ l Will the patient’s information preferences allow for informed consent?

17. Step 4: Discuss the patient’s situation, clinical trial l Straightforward presentation l Avoid jargon l Check for understanding l Encourage questions l Review consent l Straightforward presentation l Avoid jargon l Check for understanding l Encourage questions l Review consent

18. Step 5: Respond to emotions l Are you using me as a guinea pig? l I’m going to go through all of this for nothing? l I’m going to give up all my ‘good’ time? l Are you using me as a guinea pig? l I’m going to go through all of this for nothing? l I’m going to give up all my ‘good’ time?

19. Step 6: Plan next steps, follow-up l Plan for next steps l Reassure the patient l Plan for next steps l Reassure the patient

20. Step 7: Review and revise periodically l Reassess Understanding Goals of care Comfort to continue participation in the clinical trial l Reassess Understanding Goals of care Comfort to continue participation in the clinical trial

21. Summary l Limited clinical trial enrollment l The ‘fighter’ as participant l Phase I plus symptom management l Informed consent l Managing conflicts of interest l SPIKES+ structure for communication l Limited clinical trial enrollment l The ‘fighter’ as participant l Phase I plus symptom management l Informed consent l Managing conflicts of interest l SPIKES+ structure for communication