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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 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1448

Last updated 2020-07-17

No results posted yet for this 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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kathleen Castro, R.N. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-19
Primary Completion
2012-06-01
Completion
2020-07-16

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01031641 on ClinicalTrials.gov