Fatigue in Emergency Center Patients
Study Details
Study Description
Brief Summary
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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.
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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.
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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 | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Fatigue in Emergency Center Patients
|
Behavioral: Surveys
2 surveys, taking about 10-15 minutes each, during Emergency Center visit
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Patient Fatigue Severity Scores Assessed With MDASI [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."
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must be admitted to the Emergency Center with a diagnosis of cancer confirmed by pathology (either hematologic malignancies or solid tumors).
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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.
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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
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Patients must be able to read and write English
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Patients must agree to participate and must sign the Informed Consent
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Patients must be 18 years or older (minimal numbers of children are evaluated in the EC)
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Patients must be able to complete the survey tool independently (without input or influence from their caregivers).
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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:
- 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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2005-0266
Study Results
Participant Flow
| Recruitment Details | Recruitment Period: 07/19/06 through 10/18/06. All participants recruited at UT MD Anderson Cancer Center. |
|---|---|
| Pre-assignment Detail | Study terminated early due to low accrual. |
| Arm/Group Title | Fatigue in Emergency Center Patients |
|---|---|
| Arm/Group Description | |
| Period Title: Overall Study | |
| STARTED | 14 |
| COMPLETED | 14 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Fatigue in Emergency Center Patients |
|---|---|
| Arm/Group Description | |
| Overall Participants | 14 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
66
|
| Sex: Female, Male (Count of Participants) | |
| Female |
5
35.7%
|
| Male |
9
64.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
14
100%
|
Outcome Measures
| Title | Patient Fatigue Severity Scores Assessed With MDASI |
|---|---|
| Description | 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." |
| Time Frame | Survey and blood draw done within 24 hours of patient's Emergency Center visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study terminated early due to low recruitment, insufficient data for analysis. |
| Arm/Group Title | Fatigue in Emergency Center Patients |
|---|---|
| Arm/Group Description | |
| Measure Participants | 0 |
Adverse Events
| Time Frame | 2 Years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Fatigue in Emergency Center Patients | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Fatigue in Emergency Center Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Fatigue in Emergency Center Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Fatigue in Emergency Center Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Xin Shelley Wang, MD, MPH / Associate Professor |
|---|---|
| Organization | UT MD Anderson Cancer Center |
| Phone | 713-745-3504 |
- 2005-0266