Clinical trial NCT02208336: 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
Official title: Evaluation of a Data Driven System for Insuring Timely Monitoring for Brain Tumor Patients for Management of Myelosuppression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-08-05
Enrollment: 79
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brain Tumor Patients

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of nonadherence (retrospective)
timeFrame: Up to 42 days (completion of treatment)
measure: Impact of nonadherence events on myelosuppression severity (retrospective)
timeFrame: Up to 90 days after completion of treatment
measure: Impact of nonadherence events on patient morbidity (retrospective)
timeFrame: Up to 90 days after completion of treatment
measure: Effect of an automated notification program on adherence rates (prospective)
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Glenn Lesser
role: PRINCIPAL_INVESTIGATOR
References: