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
April 17, 2017 updated by: Wake Forest University Health Sciences
Evaluation of a Data Driven System for Insuring Timely Monitoring for Brain Tumor Patients for Management of Myelosuppression
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.
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
79
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Comprehensive Cancer Center of Wake Forest University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Brain Tumor Patients
Description
Inclusion Criteria:
- RETROSPECTIVE: All patients seen in Dr. Lesser's clinic who received concurrent temozolomide and radiation therapy followed by adjuvant temozolomide for newly diagnosed malignant gliomas from 01/01/07 through 03/31/2010 will be analyzed
- PROSPECTIVE: All patients seen in Dr. Lesser's clinic who receive concurrent temozolomide and radiation therapy followed by adjuvant temozolomide for newly diagnosed malignant gliomas during and after the construction of the system until the end of the study
Exclusion Criteria:
- Patients participating in clinical trials or other deviations from non-standard therapies that engender similar monitoring risk will be evaluated for this study on a case by case basis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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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Ancillary studies
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frequency of nonadherence (retrospective)
Time Frame: Up to 42 days (completion of treatment)
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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.
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Up to 42 days (completion of treatment)
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Impact of nonadherence events on myelosuppression severity (retrospective)
Time Frame: Up to 90 days after completion of treatment
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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.
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Up to 90 days after completion of treatment
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Impact of nonadherence events on patient morbidity (retrospective)
Time Frame: Up to 90 days after completion of treatment
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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.
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Up to 90 days after completion of treatment
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Effect of an automated notification program on adherence rates (prospective)
Time Frame: Up to 6 years
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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.
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Up to 6 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2010
Primary Completion (ACTUAL)
February 23, 2015
Study Completion (ACTUAL)
February 23, 2015
Study Registration Dates
First Submitted
August 1, 2014
First Submitted That Met QC Criteria
August 1, 2014
First Posted (ESTIMATE)
August 5, 2014
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2017
Last Update Submitted That Met QC Criteria
April 17, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCCWFU 99210 (OTHER: Comprehensive Cancer Center of Wake Forest University)
- P30CA012197 (U.S. NIH Grant/Contract)
- NCI-2014-01602 (REGISTRY: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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