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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Cephalon |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00450541 |
Primary Objective:
-To develop a detailed description of the experience of fatigue for patients with cancer.
Secondary Objective:
-To define the content domain for the assessment and measurement of fatigue in patients with cancer.
Condition | Intervention |
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Advanced Cancer |
Behavioral: Questionnaire Behavioral: Interview |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | The Experience of Fatigue for Patients With Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients with cancer that may be experiencing fatigue.
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Behavioral: Questionnaire
Four questionnaires taking 15-20 minutes total to complete.
Behavioral: Interview
Interview lasting about 30 minutes.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with cancer that may be experiencing fatigue.
Inclusion Criteria:
Exclusion Criteria:
Contact: Loretta A. Williams, DSN | 713-745-3470 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Loretta A. Williams, DSN |
Principal Investigator: | Loretta A. Williams, DSN | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Loretta A. Williams, DSN ) |
Study ID Numbers: | 2007-0004 |
Study First Received: | March 20, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00450541 |
Health Authority: | United States: Institutional Review Board |
Advanced Cancer Fatigue Interview Questionnaire Survey |
Fatigue |