Return to List

Study Summary
No. 2005-0936:.......Solid Tumors......Carmen Escalante......General Internal Medicine/Ambulatory Treatment & Emergency Care
.
Study Summary Title
Study Summary
Number:		2005-0936
Study Title:Fatigue and Symptom Burden in Febrile Neutropenia
.
Physician New Patient Referral
Name:Carmen EscalantePatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:General Internal Medicine/Ambulatory Treatment & Emergency CareReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-4516
Contact us about clinical trials
.
General Information
Disease Group:Solid TumorsSupported By:N/A
Phase of Study:N/AReturn
Visit:		The patients return on day #2, day #3 and day #7 of the treatment pathway.
This study does not require additional visits other than those that are already
necessary as standard outpatient treatment of febrile neutropenia.
Treatment
Agents:		NoneHome Care:There are no treatments given at home.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		This study will not be performed on inpatients.
Description/
Intervention:		Unavailable
.
Study Objectives / Outcomes
This is a prospective study with the following objectives:
1.1 Primary Objectives
1. To determine whether fatigue improves as patients are treated for febrile neutropenia (Day #1, Day #2 and Day #6).

1.2 Secondary Objectives
1. 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.
2. 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.
.
Study Status Information
Study Activation / Registration Date:05/31/2007
IRB Review and Approval Date:05/31/2007
Study Type:Other
Recruitment Status:Open
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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.
.
Links
Registration Number: NCT00503854
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center