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Multiple Cancers clinical trials

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NCT ID: NCT01031641 Completed - Lymphomas Clinical Trials

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

Start date: November 19, 2009
Phase:
Study type: Observational

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.