Fatigue and Its Symptom Cluster Related to Inflammatory Cytokine Profiles in Cancer Patients Seeking Emergency Care
One of the ways to learn about the symptoms of cancer and the effect of cancer treatment is
by rating how severe symptoms are and how they interfere with daily activity. Researchers
can also compare these ratings to the levels of certain proteins called cytokines that are
found in the blood while the patient is experiencing symptoms.
If you agree to take part in this study, you will be asked to complete 2 surveys during your
Emergency Center visit. One survey will measure physical and mental symptoms (such as
sadness or distress). The other survey will ask you for personal "demographic" information
(such as your age and marital status). Completing the questionnaires will take about 10-15
minutes. During the Emergency Center visit, about 1 tablespoon of blood will be drawn for
cytokine testing.
Research staff will also collect other information from your medical record, clinical
information, and lab results. This information may include cancer diagnosis, cancer
treatment, performance status (your ability to perform daily activities), disease status,
and any medications you are taking at that time.
This is an investigational study. About 520 patients will participate in this study. All
will be enrolled at M. D. Anderson.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Patient Fatigue Severity Scores Assessed With MDASI
Descriptive factor and cluster analysis using MD Anderson Symptom Index (MDASI) 13 core symptom items to form 1) treatment-related factor (nausea and vomiting) and 2) general severity factor (the remaining 11 core symptom items). Patients rate intensity and interference of symptoms on 0-10 numeric scales from "not present" to "as bad as you can imagine." Patients also rate the amount of interference with daily activities caused by symptoms on 0-10 numeric scales from "did not interfere" to "interfered completely."
Survey and blood draw done within 24 hours of patient's Emergency Center visit
No
Xin Shelley Wang, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2005-0266
NCT00504985
August 2005
April 2008
Name | Location |
---|---|
U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |