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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02184 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2005-0936 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (questionnaire) | Patients complete a questionnaire on days 1, 2, and 6 regarding fatigue, sleep disturbance, depression, and other symptoms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical factors associated with cancer patients with low risk for outpatient treatment of febrile neutropenia | Will be explored using descriptive statistics, bivariate correlation and scatter plots. The association between each clinical factor and fatigue improvement (yes or no) will be assessed using Wilcoxon's rank-sum test (for continuous clinical factors) or Pearson's chi^2 test (for categorical clinical factors). Univariate and multivariable logistic regression models will be fit using fatigue severity as a dependent variable and baseline demographic information, clinical factors and laboratory values as potential predictors. Anemia, using granulocyte-colony stimulating factor (G-CSF) before enrollment will be controlled for as confounding variables in the model. The goodness-of-fit of the model will be evaluated using partial residual plots. Furthermore, a multivariable linear mixed model will be fit for the repeating measurements of fatigue scores, which takes into account the correlation among the scores obtained within the same subject over time. |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatient seen at MD Anderson Cancer Center
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Escalante | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Up to day 6 |
| Demographic information in cancer patients with low risk for outpatient treatment of febrile neutropenia and fatigue | Will be explored using descriptive statistics, bivariate correlation and scatter plots. Univariate and multivariable logistic regression models will be fit using fatigue severity as a dependent variable and baseline demographic information, clinical factors and laboratory values as potential predictors. Furthermore, a multivariable linear mixed model will be fit for the repeating measurements of fatigue scores, which takes into account the correlation among the scores obtained within the same subject over time. The mixed model will include a random patient effect and baseline demographic information, clinical factors and laboratory values will be fit as fixed effects. | Up to day 6 |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |