PRO-CTCAE Task 8 Committee: Feasibility Research

March 18th 2011 (11am EST)Kickoff Telecon

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

CTCAE

• Lexicon of about 800 items to characterize adverse events

• Standard in all cancer clinical trials

Adverse Reactions Table

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

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

PRO-CTCAE

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

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!)

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

Create Form Form Builder

Manage Schedule

Secondary conditional

item

Shaking Chills Shivering

Study Reports

Patient-Reported Outcomes Version of the CTCAE

https://wiki.nci.nih.gov/x/cKul

Aim 2: Conduct Feasibility Study

2 Trials Identified

• CALGB: Eribulin phase III• RTOG: Manuka Honey randomized phase II

Eribulin Trial

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

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?

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?