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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancers, Hematologic Diseases, Solid Tumors

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Trial Information

Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing


Screening:

The study staff will talk to your doctor or nurse, and/or look at your medical record, to
see if you are currently receiving treatment. The study staff will also look at your
medical record to see if you have any future clinic visits at M. D. Anderson. This is the
first step of "screening" to help the researchers decide if you are eligible to take part in
this study.

If you are found to be possibly eligible to take part in this study based on the first step
of screening, the second step of screening will occur:

At your clinic visit, the study staff will talk to you about this study. You will be asked
questions about school, which should take about 2 minutes.

Study Visit If you are found to be eligible and you agree to take part in this study, you
will look at a list of 34 cancer symptoms if you are a male or a list of 36 cancer symptoms
if you are a female. You will fill out a questionnaire that asks you to mark each symptom
that you may be experiencing at this time, and other information about the symptoms such as
how often they occur.

After you complete the questionnaire, you will be interviewed by the study staff about how
you answered some of the questions. For example, you will be asked if the words describing
the symptoms were easy to understand or if other words may be more clear.

There are no right or wrong answers to any part of this study. Researchers are interested
in your thoughts about the words.

Filling out the questionnaire will take about 10-15 minutes. The interview will take about
20-30 minutes.

Study Data:

The interview will be audio-recorded. Only the study staff will hear the recording. The
recording will be saved on a password-protected computer that can only be accessed by the
study staff.

Your responses will be coded without using your name or other personal identifying
information. Only the study staff will have access to the code numbers and be able to
identify you.

Your responses will not be shared with your doctor without your consent.

In some of the questions, you will be asked about your feelings (for example, whether you
feel unhappy or anxious). If your responses show that you may be having emotional
difficulties, you will be given a list of community agencies that provide services for
emotional issues. You may also speak to your doctor about your feelings.

Length of Study:

After the study visit, your active participation will be over. In some cases, the study
staff may call you to ask that you clarify some of your answers. Your medical record may
also be checked to confirm the cancer diagnosis and your treatments.

This is an investigational study. Up to 100 patients will take part in this study. Up to
20 will be enrolled at M. D. Anderson.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Tito Mendoza, PhD, MS, MED

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0182

NCT ID:

NCT00909207

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Advanced Cancers
  • Hematologic Diseases
  • Solid Tumors
  • Advanced Cancers
  • Hematologic Disorders
  • Solid Tumors
  • Cognitive Interview
  • Patient-Reported Outcomes
  • PRO
  • Common Terminology Criteria for Adverse Events
  • CTCAE
  • PRO-CTCAE
  • Cancer Symptoms
  • Interview
  • Hematologic Diseases
  • Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Duke University Medical CenterDurham, North Carolina  27710
UT MD Anderson Cancer CenterHouston, Texas  77030