Fatigue and Symptom Burden in Febrile Neutropenia
This trial is active, not recruiting.
|Conditions||solid tumors, febrile neutropenia|
|Sponsor||M.D. Anderson Cancer Center|
|Start date||May 2007|
|End date||May 2017|
|Trial size||70 participants|
|Trial identifier||NCT00503854, 2005-0936|
- To determine whether fatigue improves as patients are treated for febrile neutropenia (Day #1, Day #2 and Day #6).
- To identify clinical factors associated in cancer patients with low risk for outpatient treatment of febrile neutropenia on either outpatient febrile neutropenia treatment pathway presenting with moderate to severe fatigue. Moderate fatigue is defined as a score of 4 through 6 on the Brief Fatigue Inventory and severe fatigue is defined as a score of 7 through 10 on the Brief Fatigue Inventory.
- To describe demographic information in cancer patients with low risk for outpatient treatment of febrile neutropenia and fatigue while enrolled in either of two outpatient febrile neutropenia treatment pathways.
Improvement in mean fatigue level from study day 1 to day 6
time frame: 6 Days (Baseline to Day 6)
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Cancer patients with solid tumors at low risk for outpatient treatment of febrile neutropenia evaluated in the EC and enrolled in outpatient febrile neutropenia pathways (pathway 1 or 2). Low risk is defined as hemodynamically stable solid tumor patients that do not have pneumonia or are on steroids. Febrile neutropenia is marked by a temperature greater than or equal to 38.3 degrees Celsius and an absolute neutrophil count (ANC) less than or equal to 1000 within 24 hours. 2. Patients must be able to speak, read and write in English. 3. Patients must be able to complete the required survey tools independently. 4. Patients must report a moderate to severe fatigue level to question # 3 of the BFI( 4 or greater on a 0-10 scale) on EC admission day. 5. Pregnant women if they meet eligibility criteria of the NF pathway and are able to take the oral/IV antibiotic prescribed by th pathway. 6. Patient must be greater or equal to 18 years of age. Exclusion Criteria: 1) Patients will be excluded from the study if they are not on the neutropenic pathway at the time of study entry.
|Official title||Fatigue and Symptom Burden in Febrile Neutropenia|
|Principal investigator||Carmen Escalante, MD|
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