Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing
Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing
1 other identifier
observational
20
1 country
4
Brief Summary
The scientific aim of this study is to evaluate patient comprehension of the 77 newly developed items as well as the extent to which the items correspond to the concepts of interest for each patient reported outcome (PRO). A secondary aim of this study is to evaluate the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system once it has been built to accommodate the learning garnered during the cognitive interviews.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2009
CompletedFirst Posted
Study publicly available on registry
May 27, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedJuly 14, 2014
July 1, 2014
3.9 years
May 22, 2009
July 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comprehension of Patient Reported Outcome (PRO) Criteria
The primary assessment tool will be the cognitive interview protocol.
1 day
Study Arms (1)
Interview
Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire.
Interventions
Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire.
Eligibility Criteria
Individuals, age 18 years or older, receiving chemotherapy and/or radiation therapy.
You may qualify if:
- Patients must be aged 18 and over
- Able to read and understand English
- Patients with a high school education or less
- Patients who are undergoing chemotherapy or radiotherapy with curative or palliative intent.
- Patient is able to provide informed consent.
- All types of cancer diagnosis
You may not qualify if:
- \) Significant cognitive impairment as determined by research staff's judgment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (4)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27708, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tito Mendoza, PhD, MS, MED
UT MD Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2009
First Posted
May 27, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2013
Last Updated
July 14, 2014
Record last verified: 2014-07