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Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

NCT02158637 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1100

Last updated 2017-05-24

No results posted yet for this study

Summary

This study is being done to try out questions from a large set of questions called the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a set of questions which asks patients about their symptoms. This study will look at properties of these questions and will provide information about how these questions can be improved for research studies. PRO-CTCAE questions were developed under a contract from the National Cancer Institute (NCI) to allow patients to self-report symptoms in future cancer clinical trials. Patients with cancer receiving treatment will complete a web-based questionnaire containing PRO-CTCAE questions and a paper booklet containing a commonly used questionnaire for assessing quality of life, functioning, and symptoms at two visits one to six weeks apart. Some patients will additionally complete web-based questionnaires containing PRO-CTCAE questions weekly for four to five weeks, while completing a daily questionnaire containing PRO-CTCAE questions using an automated telephone system. Lastly, a small number of patients will complete only a single visit in which a web-based, telephone-based, and paper-based questionnaire containing PRO-CTCAE items is completed in addition to a paper booklet containing a commonly used questionnaire for assessing quality of life, functioning, and symptoms. The primary hypothesis is that scores for PRO-CTCAE questions will differ between patients with high versus low general well-being as measured by your doctor using a scale called the Eastern Cooperative Oncology Group Performance Score.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Amylou C. Dueck, PhD · Mayo Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-03-31
Completion
2017-03-13

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02158637 on ClinicalTrials.gov