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Fatigue in Emergency Center Patients

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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
  1. 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.
  2. 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.
  3. 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

Detailed Description:

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 Design

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fatigue and Its Symptom Cluster Related to Inflammatory Cytokine Profiles in Cancer Patients Seeking Emergency Care
Study Start Date : August 2005
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Fatigue in Emergency Center Patients Behavioral: Surveys
2 surveys, taking about 10-15 minutes each, during Emergency Center visit
Other Name: Questionniare


Outcome Measures

Primary Outcome Measures :
  1. 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
About 1 tablespoon of blood drawn for cytokine testing.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients admitted to the UT MD Anderson Cancer Center Emergency Center who are seeking emergency care for fever, pain, shortness of breath, or cancer therapy-related gastrointestinal toxicities.
Criteria

Inclusion Criteria:

  1. Patients must be admitted to the Emergency Center with a diagnosis of cancer confirmed by pathology (either hematologic malignancies or solid tumors).
  2. Patients with either hematologic malignancies or solid tumors must either be currently undergoing active cancer treatment (received chemotherapy, radiotherapy, chemoradiotherapy, blood or bone morrow transplant, surgery, immunotherapy anytime during the past month) or not receiving any cancer treatments in past month.
  3. Patient's chief complaint upon admission to the EC must be one or more of the following four conditions: a. fever (38.3°C or higher) in past 24 hours b. pain c.any chemotherapy-related GI toxicities (such as nausea, vomiting, diarrhea, or constipation) d.shortness of breath
  4. Patients must be able to read and write English
  5. Patients must agree to participate and must sign the Informed Consent
  6. Patients must be 18 years or older (minimal numbers of children are evaluated in the EC)
  7. Patients must be able to complete the survey tool independently (without input or influence from their caregivers).
  8. Patients whose performance status allows them to complete the survey (i.e., patients who do not have altered mental/cognitive status, and patients without emergent illness and hemodynamic instability---for example, status epilepticus, sepsis, cardiac arrest, and any life-threatening condition).

Exclusion Criteria:

1) Patients who were already enrolled on this protocol in a previous visit to this EC will not be enrolled again, regardless of their reasons for the current EC visit (same or different reason).

Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Xin Shelley Wang, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00504985     History of Changes
Other Study ID Numbers: 2005-0266
First Posted: July 20, 2007    Key Record Dates
Results First Posted: May 4, 2010
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Hematologic Malignancy
Fatigue
Emergency Center
Survey

Additional relevant MeSH terms:
Neoplasms
Emergencies
Fatigue
Disease Attributes
Pathologic Processes
Signs and Symptoms