Clinical trial NCT00504985: Fatigue in Emergency Center Patients
Official title: Fatigue and Its Symptom Cluster Related to Inflammatory Cytokine Profiles in Cancer Patients Seeking Emergency Care
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Advanced Cancer
Hematologic Malignancy
Fatigue
Keywords: Advanced Cancer
Hematologic Malignancy
Fatigue
Emergency Center
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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).

Primary outcomes:
measure: Patient Fatigue Severity Scores Assessed With MDASI
timeFrame: Survey and blood draw done within 24 hours of patient's Emergency Center visit
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Xin Shelley Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: