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PRO-CTCAE Task 8 Committee: Feasibility Research

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

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PRO-CTCAE Task 8 Committee: Feasibility Research

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  1. PRO-CTCAE Task 8 Committee: Feasibility Research March 18th 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

  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” • Survey of cancer research stakeholders • Items developed • Cultural literacy assured • Cognitive interviews • Software platform developed • Usability testing • Validation study • Feasibility assessment (that’s us!)

  9. Example: Mucositis

  10. Create Form Form Builder

  11. Manage Schedule

  12. Shaking Chills Shivering Secondary conditional item

  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?

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