Clinical trial · Observational
Fatigue and Symptom Burden in Low-Risk Cancer Patients Undergoing Treatment for Febrile Neutropenia
Fatigue and Symptom Burden in Febrile Neutropenia
NCT00503854CI-TRIAL-00035388completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Febrile Neutropenia | — | UNRESOLVED | — |
| Solid Neoplasm | Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (questionnaire)
- description
- Patients complete a questionnaire on days 1, 2, and 6 regarding fatigue, sleep disturbance, depression, and other symptoms.
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Mean fatigue level evaluated by Brief Fatigue Inventory (BFI)
- timeFrame
- Up to day 6
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.