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Amylou C. Dueck (Mayo Clinic) – Task 7 Lead Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events.

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Presentation on theme: "Amylou C. Dueck (Mayo Clinic) – Task 7 Lead Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events."— Presentation transcript:

1 Amylou C. Dueck (Mayo Clinic) – Task 7 Lead Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO- CTCAE)

2 Weekly “Task 7” teleconferences since March 2009 – Regular attendees All sites plus NCI and FDA Experts in validation studies Oncologists, psychometricians, statisticians Patient advocates – Adhoc experts Example: Arthur Stone (advice on design of recall substudy) Agenda and task documents available on the PRO- CTCAE Wiki – https://wiki.nci.nih.gov/x/cKul – Click on “Task 7” Process

3 Process (con’d 1) Literature search on validation of similar multi- symptom tools Developed a concept document Underwent review by a working group of the NCI’s Symptom/Quality of Life (SxQOL) Committee

4 Process (con’d 2) Developed interactive voice response (IVR) telephone platform with Perceptive Informatics (recall substudy) Developed protocol document Planned activation June 2010 Protocol modification underway to incorporate NCCCP sites

5 To assess measurement properties of newly developed PRO-CTCAE items: Validity Reliability Sensitivity Recall period N=900 to be accrued at 10 sites – Mayo, Memorial Sloan-Kettering, MD Anderson, Duke, Dana-Farber, 5 NCCCP Sites Objectives of Validation Study

6 Features of Validation Study Rigorous assessment of measurement properties on an item-by-item basis – Follows FDA guidance document even though PRO-CTCAE items are intended for adverse event monitoring instead of as primary endpoints Planned accrual of a diverse patient population – Six disease cohorts with a range of chemotherapies and/or radiation therapy – ECOG performance status 0-4 – Targeting minority patients through NCCCP participation

7 Eligibility (Inclusions) ≥18 years of age Disease and treatment matching 1 of the 6 following cohorts: – Adjuvant breast cancer on chemotherapy – Lymphoma/myeloma on chemotherapy – Metastatic prostate/bladder cancer on chemotherapy – Metastatic or locally advanced lung cancer on chemotherapy OR receiving daily radiation therapy for ≥21 more days (concurrent chemotherapy allowed) – Metastatic colorectal cancer on chemotherapy – Head/neck/gastroesophageal cancer receiving daily radiation therapy for ≥21 more days (concurrent chemotherapy allowed) Patient is expected to return to clinic in 1-6 weeks English speaking NOTE: CAN BE ANY ECOG PS – We are particularly interested in accruing patients with ECOG PS 2-4!

8 Eligibility (Exclusion) Clinically significant cognitive or memory impairment in the opinion of clinical or research staff

9 Schema Group A (N~100) – Patients receiving daily radiation for ≥21 more days in the Lung or Head/Neck/Gastroesophageal cohorts – Primary validation study plus recall and test-retest reliability substudies Group B (N~100) – Patients with 4-5 planned weekly clinic visits – Primary validation study plus recall substudy Group C (N~700) – All other eligible patients – Primary validation study (only requires two clinic visits 1-6 weeks apart) Rationale: Keep the study simple for most patients (Group C) but target accrual of patients with more frequent clinic visits (Groups A & B) for the recall and test-retest reliability substudies

10 Schema (Group C) [ Patient compensation: $10 / visit ]

11 * Clinical Anchors ECOG Performance Status Patient treatment information – RT yes/no – Surgery yes/no – Chemotherapy yes/no + regimen Patient medication information (yes/no for each) – Hormonal therapy – Opioid (narcotic) pain meds – Laxatives – Nausea meds – Sleep aids – Anti-diarrhea meds – Antacids – Anxiety meds – Inhalers – Depression meds.

12 Schema (Groups A & B) [ Patient compensation: $20 / visit ]

13 Statistics / Power Primary: Assess convergent validity of each PRO-CTCAE item – Compare each item between patients with ECOG PS 0-1 vs 2-4 at the Visit 1 time point using t-tests – Adjust for multiplicity using Hochberg’s step-up method – Power Core items: 99% for large effect size, 63-90% for moderate effect size Non-core items: 48-99% for large effect size, 9-65% for moderate effect size

14 Other Planned Analyses Assess the test-retest reliability of selected PRO-CTCAE items Assess the responsiveness (sensitivity to change) and clinical significance of each PRO- CTCAE item Investigate cut-points for notification of severe PRO-CTCAE symptoms

15 Other Planned Analyses (con’d) Compare clinician- and patient-reported CTCAE items Compare daily, 7-day, 2-week, 3-week, and 4- week recall periods Explore construction of an overall grade for symptoms with multiple items Assess measurement properties within ethnic/racial and education level subgroups

16 ASCO Poster Information Title: Validation study of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) Presenting author: Dueck AC Session: Trials in Progress Poster Session Date: Monday, June 07, 2010 Time: 8:00 AM - 12:00 PM Presentation Order: 175 Poster Board #: 47E Location: S Hall A2


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