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

NCT00503854 | Completed

• 3 other identifiers: 2005-0936NCI-2018-02184P30CA016672
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Febrile Neutropenia; Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Mean fatigue level evaluated by Brief Fatigue Inventory (BFI)

  Improvement in mean fatigue level will be assessed. Summary statistics, such as mean, standard deviation, median and range will be provided at the Emergency Center (EC) admission and along the treatment period at days 1, 2, and 6. Exploratory plots such as scatter plots and box plots will also be prepared. For those patients requiring longer time of treatment (greater than 7 days) and remaining on the febrile neutropenia (NF) pathway, the fatigue levels at the time of pathway discharge will also be summarized. The change in fatigue levels between day 1 and day 6 will be calculated for each item in the BFI. Wilcoxon signed rank test will be used to assess the significance of change. The change in fatigue score for question # 3 between EC admission and day 6 of the study will also be calculated and assessed using Wilcoxon signed rank test.

  Up to day 6

Secondary Outcomes (2)

• 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

Study Arms (1)

Observational (questionnaire)

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

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Ancillary studies

Also known as: Questionnaires

Observational (questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient seen at MD Anderson Cancer Center

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Fatigue; Febrile Neutropenia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Carmen Escalante

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 19, 2007
• Study Start: May 31, 2007
• Primary Completion: April 5, 2018
• Study Completion: April 5, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Locations

US (1)