Clinical trial NCT00909207: Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancers
Hematologic Diseases
Solid Tumors
Keywords: Advanced Cancers
Hematologic Disorders
Solid Tumors
Cognitive Interview
Patient-Reported Outcomes
PRO
Common Terminology Criteria for Adverse Events
CTCAE
PRO-CTCAE
Cancer Symptoms
Interview
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals, age 18 years or older, receiving chemotherapy and/or radiation therapy.

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Comprehension of Patient Reported Outcome (PRO) Criteria
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Tito Mendoza, PhD, MS, MED
role: STUDY_CHAIR
References: