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Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00909207
First received: May 22, 2009
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Advanced Cancers
Hematologic Diseases
Solid Tumors
 Behavioral: Interview

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Interview
Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire.
 Behavioral: Interview
Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals, age 18 years or older, receiving chemotherapy and/or radiation therapy.

Criteria

Inclusion Criteria:

  1. Patients must be aged 18 and over
  2. Able to read and understand English
  3. Patients with a high school education or less
  4. Patients who are undergoing chemotherapy or radiotherapy with curative or palliative intent.
  5. Patient is able to provide informed consent.
  6. All types of cancer diagnosis

Exclusion Criteria:

1) Significant cognitive impairment as determined by research staff's judgment

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909207

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27708
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Tito Mendoza, PhD, MS, MED UT MD Anderson Cancer Center
  More Information

Additional Information:
U.T. M.D. Anderson Cancer Center Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00909207     History of Changes
Other Study ID Numbers: 2009-0182
Study First Received: May 22, 2009
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Hematologic Disorders
Solid Tumors
Cognitive Interview
Patient-Reported Outcomes
PRO
 Common Terminology Criteria for Adverse Events
CTCAE
PRO-CTCAE
Cancer Symptoms
Interview

Additional relevant MeSH terms:
Hematologic Diseases
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013