Overview

This trial is active, not recruiting.

Conditions solid tumors, febrile neutropenia
Treatment questionnaire
Sponsor M.D. Anderson Cancer Center
Start date May 2007
End date May 2017
Trial size 70 participants
Trial identifier NCT00503854, 2005-0936

Summary

Primary Objectives:

- To determine whether fatigue improves as patients are treated for febrile neutropenia (Day #1, Day #2 and Day #6).

Secondary Objectives:

- 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
questionnaire Survey
Questionnaires taking about 15 to 30 minutes total.

Primary Outcomes

Measure
Improvement in mean fatigue level from study day 1 to day 6
time frame: 6 Days (Baseline to Day 6)

Eligibility Criteria

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.

Additional Information

Official title Fatigue and Symptom Burden in Febrile Neutropenia
Principal investigator Carmen Escalante, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.