Trial Information

Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing

Background:

The current approach to monitoring adverse symptom events in NCI-sponsored treatment trials
is clinical staff reporting, using items from the Common Terminology Criteria for Averse
Events (CTCAE). Of the 1,059 discrete items in the CTCAE, approximately 77 contain a
subjective component sufficient enough to be amenable to patient self-reporting such as
pain, fatigue, nausea, and hair loss. There is general agreement that the patient, via a
self-report, is the best source for reporting symptoms. In contrast to cancer treatment
protocols, directly collecting symptom data is routine in symptom management clinical
trials. Among investigators, regulatory agencies, and pharmaceutical sponsors, increasing
attention is being paid to incorporating self-reports when documenting AEs. Studies have
shown that when compared to clinician reports, patients report earlier onset, greater
severity, and longer duration of symptoms.

In September 2008, the NCI awarded a contract (N02-PC-85002-29; PI: Basch; Co-I: Hay) to
support the development of an electronic-based and psychometrically robust patient-reported
outcomes version of the symptom-related AEs listed in the CTCAE in an effort to improve the
accuracy and precision of grading of this class of AEs. To achieve this goal, we will
conduct cognitive interviews with 77 newly-developed PRO items that will subsequently be
subjected to psychometric analysis, usability testing, and, ultimately, feasibility testing
in a range of treatment settings among diverse groups of patients. This current protocol
focuses on the procedure for cognitive interviewing and usability testing of the newly
developed items.

Objectives:

The overall goal of this proposed study is to evaluate patient comprehension of 77 newly
developed PRO items in a range of treatment settings among diverse groups of cancer
patients. The primary objective is to evaluate patients understanding of the language. The
secondary objective is to evaluate the usability of the technology interface for collecting
the PRO data of the PRO-CTCAE system.

Eligibility:

Patients will be eligible for the study if they are 1) aged 18 or older; 2) English-fluent;
3) undergoing chemotherapy and/or radiotherapy with curative or palliative intent; and 4)
can provide informed consent. Patients will be excluded who have significant cognitive
impairment.

Design:

We will conduct up to three rounds of cognitive interviews in 100 cancer patients at
participating cancer centers and satellite sites including MSKCC, Dana Farber Cancer
Institute (DFCI), Duke, and M.D. Anderson. After completion of the first round of
interviews, results will be analyzed for problematic items. Revised items will be reviewed
in second and third rounds as needed. The final PRO-CTCAE items will proceed to usability
testing and validation. Usability testing will comprise three main components: (1)
observation of users interacting with the web-based assessment system coupled with think
aloud protocols and extensive field notes; (2) user feedback using semi-structured
interviews and short surveys; and, (3) web analytics including tracking for different web
pages, with clickstream analysis. The validation study will assess the convergent validity
of each PRO-CTCAE item by comparing each item between patients with ECOG PS 0-1 versus 2-4
at the visit 1 time point. Convergent validity will be further assessed by repeating the
primary analysis at time point 2.