The EPEC-O Project Education in Palliative and End-of-life Care - Oncology

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

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

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

4. Video

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

6. Why patients enroll in trials • Hope for response • Recognize small chance for benefit • Patients as “fighters” • Realistic not nihilistic Meropol NJ, et al. J ClinOncol. 2003 .

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

8. Opportunities in clinical trials • Offer clinical trials • Identify “fighters” • Honest presentation of Phase I trials • Phase I and symptom management

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

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

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

12. Discussing Phase I trialsseven-step protocol . . . • Set the stage. • Determine what the patient/family knows. • How much does the patient want to know—enough for informed consent?

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

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

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

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

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

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

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

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

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