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NCT01031641 · ClinicalTrials.gov registry record
Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing
A clinical trial of Lymphomas and Leukemias, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 1,448
- Enrollment target
- 2
- Study locations
NCT01031641 is a study of Lymphomas and Leukemias that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1,448 participants, above the 888-participant average among 7 other Lymphomas trials with a reported enrollment target (63% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT01031641, a study of Lymphomas and Leukemias, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 1,448 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 1,448 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 888-participant average among 7 other Lymphomas trials with a reported enrollment target (63% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Lymphomas appearing as the primary indexed condition, and to 0 interventions.
NCT01031641 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Texas.
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.
Who is sponsoring clinical trial NCT01031641?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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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Related
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