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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01602 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 99210 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research trial studies electronic medical record review in monitoring the effects of adherence on myelosuppression and morbidity in patients with newly diagnosed brain tumors receiving temozolomide and radiation therapy. Myelosuppression is a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets and is a side effect of some cancer treatments. Morbidity is a term that refers to having a symptom of disease or medical problems caused by a treatment. Monitoring patients' electronic medical records to compare side effects, such as myelosuppression and morbidity, with treatment adherence may be a way to enhance patient care by organizing data for medical staff.
PRIMARY OBJECTIVES:
I. Retrospectively measure the frequency of nonadherence with established monitoring guidelines in the target patient population.
II. Retrospectively assess the impact of nonadherence events on myelosuppression severity and patient morbidity.
III. Prospectively measure the effect of an automated notification program on adherence rates.
SECONDARY OBJECTIVES:
I. Quantify any time savings realized by patient care staff through the use of such a program.
II. Quantify the number of patient care interventions that directly result from this automated monitoring and notification program.
OUTLINE:
Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (electronic medical record review) | Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical chart review | Other | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of nonadherence (retrospective) | A two-sided 95.0% confidence interval for a single proportion using the large sample normal approximation will be extended from 8.1% in the observed proportion for an expected proportion of 25% non-adherence. | Up to 42 days (completion of treatment) |
| Impact of nonadherence events on myelosuppression severity (retrospective) | Severe myelosuppression will be defined as grade 3 or grade 4 myelosuppression from Common Terminology Criteria for Adverse Events version 3.0 criteria. The dates of any severe myelosuppressive events will be recorded. A Fisher's exact test with a 0.050 two-sided significance level will be used. | Up to 90 days after completion of treatment |
| Impact of nonadherence events on patient morbidity (retrospective) | Patient morbidity (including date of event) will be assessed on all participants with severe myelosuppression, and includes: death during treatment with temozolomide or up to 90 days after treatment, the number of transfusions received for myelosuppression during treatment with temozolomide or up to 90 days after treatment, and the length of the hospital stay for myelosuppression during treatment with temozolomide or up to 90 days after treatment. A Fisher's exact test with a 0.050 two-sided significance level will be used. | Up to 90 days after completion of treatment |
| Effect of an automated notification program on adherence rates (prospective) | To compare the rates of adherence between the retrospective and prospective time periods, a Fisher's exact test with a 0.050 two-sided significance level will be used. | Up to 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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Brain Tumor Patients
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Lesser | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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