Fatigue in Emergency Center Patients

Fatigue Clinical Trial

Official title:

Fatigue and Its Symptom Cluster Related to Inflammatory Cytokine Profiles in Cancer Patients Seeking Emergency Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00504985
• Other study ID #: 2005-0266
• Status: Terminated
• Phase: N/A
• First received: July 18, 2007
• Last updated: July 26, 2012
• Start date: August 2005
• Est. completion date: April 2008

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Cancer
• Emergencies
• Fatigue
• Hematologic Malignancy

Intervention

Behavioral:
• Surveys
2 surveys, taking about 10-15 minutes each, during Emergency Center visit

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   UT MD Anderson Cancer Center website