1. PRO-CTCAE Task 8 Committee: Feasibility Research March 18 th 2011 (11am EST) Kickoff Telecon

2. Agenda 1 – Introductions 2 – Overview of PRO-CTCAE Task 8/SOW* 3 – Research questions/goals 4 – Protocols: Eribulin* (CALGB) and Manuka Honey (RTOG) 5 – Timeline 6 – Next call: Friday, 4/1/2011

3. CTCAE Lexicon of about 800 items to characterize adverse events Standard in all cancer clinical trials

4. Adverse Reactions Table

5. Example: Mucositis CTCAE/MedDRA Term CTCAE Grade 1CTCAE Grade 2CTCAE Grade 3CTCAE Grade 4 Mucositis oral Asymptomatic or mild symptoms; intervention not indicated Moderate pain; not interfering with oral intake; modified diet indicated Severe pain; interfering with oral intake Life-threatening consequences; urgent intervention indicated

6. CTCAE “Symptom Items” About 10% of CTCAE items are symptoms Currently reported by clinical staff Abundant evidence that staff under-reports important adverse symptom events

7. PRO-CTCAE In 2008, NCI contracted to develop and evaluate a patient version of the CTCAE, called the PRO-CTCAE

8. Other “Tasks” 1.Survey of cancer research stakeholders 2.Items developed 3.Cultural literacy assured 4.Cognitive interviews 5.Software platform developed 6.Usability testing 7.Validation study 8.Feasibility assessment (that’s us!)

9. Example: Mucositis CTCAE/MedDRA Term CTCAE Grade 1CTCAE Grade 2CTCAE Grade 3CTCAE Grade 4 Mucositis oral Asymptomatic or mild symptoms; intervention not indicated Moderate pain; not interfering with oral intake; modified diet indicated Severe pain; interfering with oral intake Life-threatening consequences; urgent intervention indicated Two ItemsResponses What was the severity of your MOUTH OR THROAT SORES at their worst? None Mild Moderate Severe Very Severe How much did MOUTH OR THROAT SORES interfere with your usual activities? Not at all A little bit Somewhat Quite a bit Very much

10. Create Form Form Builder

11. Manage Schedule

12. Secondary conditional item Shaking Chills Shivering

13. Study Reports

14. Patient-Reported Outcomes Version of the CTCAE https://wiki.nci.nih.gov/x/cKul

15. Aim 2: Conduct Feasibility Study

16. 2 Trials Identified CALGB: Eribulin phase III RTOG: Manuka Honey randomized phase II

17. Eribulin Trial

18. PRO-CTCAE Preliminary Design 11 symptoms (20 items) – Fatigue, nausea, vomiting, diarrhea, constipation, insomnia, sensory neuropathy, mucositis, pain, anorexia, alopecia Administered via IVRS weekly Subcontract with CALGB and Mayo Aims: – 1: Discern between treatment arms – 2: Assess feasibility

19. Feasibility Patient-level – willing and able to self-report – satisfaction Staff-level (CRAs, investigators) – Willing/able to register/train patients – consider this a valuable activity Group-level and Site-level – Feasibility of implementation – Cost of implementation – Efficiency How do we measure these?

20. Site-Level Feasibility: In the Concept Semi-structured interviews with study personnel at selected sites Explore the barriers and challenges to implementation Assess cost, technical issues, and administrative burden DISCUSSION: How do we do this?