PRO-CTCAE Task 8 Committee: Feasibility Research March 18 th 2011 (11am EST) Kickoff Telecon.
PRO-CTCAE Task 8 Committee: Feasibility Research
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Transcript of PRO-CTCAE Task 8 Committee: Feasibility Research
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PRO-CTCAE Task 8 Committee: Feasibility Research
March 18th 2011 (11am EST)Kickoff Telecon
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Agenda
1 – Introductions2 – Overview of PRO-CTCAE Task 8/SOW*3 – Research questions/goals4 – Protocols: Eribulin* (CALGB) and Manuka
Honey (RTOG)5 – Timeline6 – Next call: Friday, 4/1/2011
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CTCAE
• Lexicon of about 800 items to characterize adverse events
• Standard in all cancer clinical trials
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Adverse Reactions Table
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Example: Mucositis
CTCAE/MedDRA Term
CTCAE Grade 1 CTCAE Grade 2 CTCAE Grade 3 CTCAE 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
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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
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PRO-CTCAE
• In 2008, NCI contracted to develop and evaluate a patient version of the CTCAE, called the PRO-CTCAE
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Other “Tasks”
1. Survey of cancer research stakeholders2. Items developed3. Cultural literacy assured4. Cognitive interviews5. Software platform developed6. Usability testing7. Validation study8. Feasibility assessment (that’s us!)
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Example: MucositisCTCAE/MedDRA
TermCTCAE Grade 1 CTCAE Grade 2 CTCAE Grade 3 CTCAE 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 Items Responses
What was the severity of your MOUTH OR THROAT SORES at their worst?
NoneMildModerate SevereVery Severe
How much did MOUTH OR THROAT SORES interfere with your usual activities?
Not at allA little bitSomewhatQuite a bitVery much
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Create Form Form Builder
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Manage Schedule
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Secondary conditional
item
Shaking Chills Shivering
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Study Reports
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Patient-Reported Outcomes Version of the CTCAE
https://wiki.nci.nih.gov/x/cKul
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Aim 2: Conduct Feasibility Study
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2 Trials Identified
• CALGB: Eribulin phase III• RTOG: Manuka Honey randomized phase II
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Eribulin Trial
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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
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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?
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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?