- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00450541
Fatigue Experience in Cancer Patients
The Experience of Fatigue for Patients With Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
STUDY PARTICIPATION:
If you agree to take part in this study, you will be interviewed by a member of the study staff and then asked to complete a series of questionnaires and verbal (spoken) questions.
During the interview, you will be asked to describe what fatigue means to you and what it is like for you to have fatigue. The interview will take place while you are at M. D. Anderson receiving your routine care. You will be interviewed alone, and the information gathered during the interview will be kept strictly confidential. The interview will take about 30 minutes to complete. It will be audiotaped so that participants' responses can be fully analyzed.
You will then be asked to complete 4 questionnaires and answer 2 separate questions.
The first questionnaire will include questions about your personal identifying information (such as your age and marital status).
You will then be asked 1 question about your quality of life and another question about how well you are performing day-to-day activities.
You will then be asked to complete a second questionnaire in which you will rate your fatigue level and how fatigue interferes with your daily activities.
You will be asked to complete a third questionnaire about your opinion of the fatigue questionnaire (the second questionnaire). For example, you will be asked if the fatigue questionnaire was easy to understand and to complete. Learning your opinion about this questionnaire will help researchers learn what important questions may be missing from the questionnaire.
Finally, you will then be asked to complete a questionnaire that asks you to rate the severity of a list of 13 symptoms and how much these symptoms interfere with some of your daily activities.
The questionnaires and additional questions should take a total of 15-20 minutes to complete.
After you have completed the interview and questionnaires, a research assistant will review your electronic medical record to collect information about your disease and treatments.
LENGTH OF STUDY:
Your participation in this study will be over after you complete the interview, the questionnaires, and the additional questions.
This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- U.T.M.D. Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- Ability to speak and read English
- Diagnosis of cancer, currently receiving treatment, receiving supportive care, or surviving after treatment
- Self report of current experience of fatigue
- Consent to participate
- Patient from M. D. Anderson Cancer Center inpatient unit or outpatient clinic
Exclusion Criteria:
- Inability to understand the intent of the study
- Medical condition that would preclude participation in an interview session lasting 40 minutes
- Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fatigue Questionnaire + Interview
|
Four questionnaires taking 15-20 minutes total to complete.
Other Names:
Interview lasting about 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Description of Cancer Patient Fatigue Experiences (Questionnaire + Interview Responses)
Time Frame: 2 Years
|
2 Years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Loretta A. Williams, DSN, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-0004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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