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Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing
NCT01031641 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Study Locations (2)
New York
- Memorial Sloan Kettering Cancer Center — New York
Texas
- MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,448 participants |
| Start Date | 2009-11-19 |
| Est. Completion | 2020-07-16 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01031641
The ClinicalTrials.gov registry entry for NCT01031641 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,448 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Lymphomas appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01031641 reports 2 study locations spanning 2 distinct geographic areas — top geographies include New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01031641 about?
NCT01031641 is a clinical study titled "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 p...
What is the current status of trial NCT01031641?
This trial is currently completed. The enrollment target is 1,448 participants. The study started on 2009-11-19. Estimated completion is 2020-07-16.
What conditions does trial NCT01031641 study?
This clinical trial studies the following conditions: Lymphomas, Leukemias, Multiple Cancers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01031641?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01031641 being conducted?
This trial has 2 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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