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

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

• Status: Completed
• Conditions: Brain Tumor
• Intervention / Treatment: Other: medical chart review

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

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (electronic medical record review); Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively.	Other: medical chart review; Ancillary studies; Other Names: chart review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

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: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• 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