Clinical trial NCT00503854: Fatigue and Symptom Burden in Low-Risk Cancer Patients Undergoing Treatment for Febrile Neutropenia
Official title: Fatigue and Symptom Burden in Febrile Neutropenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Febrile Neutropenia
Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient seen at MD Anderson Cancer Center

Brief summary: This trial studies how fatigue and symptom burden in low-risk cancer patients undergoing treatment for febrile neutropenia. Cancer and numerous cancer treatments are associated with various symptoms including anemia, fever, and neutropenia, which may also be associated with fatigue. Treating low-risk cancer patients for febrile neutropenia may reduce levels of fatigue.

Detailed description: PRIMARY OBJECTIVES I. To determine whether fatigue improves as patients are treated for febrile neutropenia (Day #1, Day #2 and Day #6).

SECONDARY OBJECTIVES I. 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.

II. 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.

OUTLINE:

Patients complete a questionnaire on days 1, 2, and 6 regarding fatigue, sleep disturbance, depression, and other symptoms.

Eligibility criteria: Inclusion Criteria:

* 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.
* Patients must be able to speak, read and write in English.
* Patients must be able to complete the required survey tools independently.
* Patients must report a moderate to severe fatigue level to question # 3 of the Brief Fatigue Inventory (BFI) (4 or greater on a 0-10 scale) on EC admission day.
* Pregnant women if they meet eligibility criteria of the febrile neutropenia (NF) pathway and are able to take the oral/intravenous (IV) antibiotic prescribed by the pathway.

Exclusion Criteria:

* Patients will be excluded from the study if they are not on the neutropenic pathway at the time of study entry.

Primary outcomes:
measure: Mean fatigue level evaluated by Brief Fatigue Inventory (BFI)
timeFrame: Up to day 6
Secondary outcomes:
measure: Clinical factors associated with cancer patients with low risk for outpatient treatment of febrile neutropenia
timeFrame: Up to day 6
measure: Demographic information in cancer patients with low risk for outpatient treatment of febrile neutropenia and fatigue
timeFrame: Up to day 6
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Carmen Escalante
role: PRINCIPAL_INVESTIGATOR
References: