Overview

This trial is active, not recruiting.

Condition brain tumor
Treatment medical chart review
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date October 2010
End date October 2016
Trial size 240 participants
Trial identifier NCT02208336, CCCWFU 99210, NCI-2014-01602, P30CA012197

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively.
medical chart review chart review
Ancillary studies

Primary Outcomes

Measure
Frequency of nonadherence (retrospective)
time frame: Up to 42 days (completion of treatment)
Impact of nonadherence events on myelosuppression severity (retrospective)
time frame: Up to 90 days after completion of treatment
Impact of nonadherence events on patient morbidity (retrospective)
time frame: Up to 90 days after completion of treatment
Effect of an automated notification program on adherence rates (prospective)
time frame: Up to 6 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Evaluation of a Data Driven System for Insuring Timely Monitoring for Brain Tumor Patients for Management of Myelosuppression
Principal investigator Glenn Lesser
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.