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

Completed

Conditions studied: Lymphomas, Leukemias, Multiple Cancers

In brief

Background: * Currently, National Cancer Institute treatment trials use clinical staff reporting to monitor adverse side effects. The clinical staff reports draw on items from the Common Terminology Criteria for Adverse Events (CTCAE). * Several of the items in the CTCAE can be adapted for use in patient self-reporting of side effects. Researchers are interested in developing a patient-reported outcome (PRO) approach to the CTCAE. Objectives: * To develop questions that can be used to create a patient-reported outcome version of the CTCAE (PRO-CTCAE). * To evaluate patient comprehension of and test the usefulness of the PRO-CTCAE questions among diverse groups of patients. Eligibility: * Individuals 18 years of age and older who are receiving chemotherapy or radiotherapy as cancer treatment. * Participants must be able to speak and understand English. Design: * Researchers will conduct up to three rounds of interviews with patients currently receiving chemotherapy or radiation therapy treatments for cancer. * Participants will be recruited independently from four different clinical treatment sites. At least 25 percent of patients will have an educational attainment of high school or less. * Each patient will complete a two-part protocol, including a set of PROs that will be followed by a series of questions to evaluate patient comprehension, memory, perceived clarity, and judgment of the PROs. * The research will be completed in approximately 1 hour, and participants will receive a small amount of compensation for their time and participation.

Key facts

Study ID
NCT01031641
Run by
National Cancer Institute (NCI)
People needed
1448
Starts
2009-11-19
Expected to finish
2020-07-16
Last updated by the study team
2020-07-17

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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