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

July 17, 2007
February 13, 2014
May 2007
May 2015   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00503854 on ClinicalTrials.gov Archive Site
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Fatigue and Symptom Burden in Febrile Neutropenia
Fatigue and Symptom Burden in Febrile Neutropenia

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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

  • Solid Tumors
  • Febrile Neutropenia
Behavioral: Questionnaire
Questionnaires taking about 15 to 30 minutes total.
Other Name: Survey
Fatique and Fever Assessment
Intervention: Behavioral: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
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May 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00503854
2005-0936
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Carmen Escalante, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP