Fatigue in Emergency Center Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00504985|
Recruitment Status : Terminated (Low Accrual)
First Posted : July 20, 2007
Results First Posted : May 4, 2010
Last Update Posted : August 1, 2012
- To describe fatigue severity and its related symptom clusters in cancer patients who are seeking emergency care for fever, pain, shortness of breath, or cancer therapy-related gastrointestinal toxicities.
- To describe inflammatory cytokine profiles in cancer patients who are seeking emergency care for fever, pain, shortness of breath, or cancer therapy-related gastrointestinal toxicities.
- To determine the type of cytokines that are associated with fatigue severity in cancer patients, with or without cancer treatment, in the early phase of infection, as well as in patients with pain, shortness of breath, or cancer therapy-related gastrointestinal toxicities.
|Condition or disease||Intervention/treatment|
|Advanced Cancer Hematologic Malignancy Fatigue||Behavioral: Surveys|
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.
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Fatigue and Its Symptom Cluster Related to Inflammatory Cytokine Profiles in Cancer Patients Seeking Emergency Care|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
|Fatigue in Emergency Center Patients||
2 surveys, taking about 10-15 minutes each, during Emergency Center visit
Other Name: Questionniare
- Patient Fatigue Severity Scores Assessed With MDASI [ Time Frame: Survey and blood draw done within 24 hours of patient's Emergency Center visit ]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."
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504985
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Xin Shelley Wang, MD||M.D. Anderson Cancer Center|