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

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.