Fatigue and Symptom Burden in Febrile Neutropenia

Fatigue and Symptom Burden in Low-Risk Cancer Patients Undergoing Treatment for Febrile Neutropenia

Sponsors

Lead sponsor: M.D. Anderson Cancer Center

Collaborator: National Cancer Institute (NCI)

Source M.D. 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.

Overall Status Completed
Start Date May 31, 2007
Completion Date April 5, 2018
Primary Completion Date April 5, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Mean fatigue level evaluated by Brief Fatigue Inventory (BFI) Up to day 6
Secondary Outcome
Measure Time Frame
Clinical factors associated with cancer patients with low risk for outpatient treatment of febrile neutropenia Up to day 6
Demographic information in cancer patients with low risk for outpatient treatment of febrile neutropenia and fatigue Up to day 6
Enrollment 70
Condition
Intervention

Intervention type: Behavioral

Intervention name: Questionnaire

Description: Ancillary studies

Arm group label: Observational (questionnaire)

Other name: Questionnaires

Eligibility

Sampling method: Non-Probability Sample

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Carmen Escalante Principal Investigator M.D. Anderson Cancer Center
Location
facility
M D Anderson Cancer Center
Location Countries

United States

Verification Date

October 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Observational (questionnaire)

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

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov