Fatigue and Symptom Burden in Febrile Neutropenia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00503854
First received: July 17, 2007
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.

Condition Intervention
Solid Tumors
Febrile Neutropenia
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fatigue and Symptom Burden in Febrile Neutropenia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Improvement in mean fatigue level from study day 1 to day 6 [ Time Frame: 6 Days (Baseline to Day 6) ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: May 2007
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fatique and Fever Assessment Behavioral: Questionnaire
Questionnaires taking about 15 to 30 minutes total.
Other Name: Survey

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with solid tumors at low risk for outpatient treatment of febrile neutropenia.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503854

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Carmen Escalante, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00503854     History of Changes
Other Study ID Numbers: 2005-0936
Study First Received: July 17, 2007
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Solid Tumors
Febrile Neutropenia
Fatigue
Symptom Burden
Questionnaire
Survey

Additional relevant MeSH terms:
Fatigue
Fever
Neutropenia
Signs and Symptoms
Body Temperature Changes
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014