Adherence Monitoring System in Managing Myelosuppression in Patients With Newly Diagnosed Malignant Gliomas Receiving Temozolomide and Radiation Therapy

Terminated

• Conditions: Malignant Glioma; Myelosuppression
• Interventions: Other: Medical Chart Review

• Registration Number: NCT02375334
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This research trial studies an adherence monitoring system in managing myelosuppression in patients with newly diagnosed malignant gliomas who are receiving temozolomide and radiation therapy. The development of an adherence monitoring system may help doctors more effectively utilize electronic medical records to manage myelosuppression during standard treatment with temozolomide and radiation therapy in patients with malignant gliomas.

Detailed Description

PRIMARY OBJECTIVES:

I. To develop an adherence monitoring system within Epic that is functionally equivalent to the previously designed and validated system in the Cancer Center Oncology Research Information System (ORIS) for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy.

II. To test the newly designed Epic system by comparing the frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) and non-adherent days generated with the frequency and timing of those generated by ORIS for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy.

SECONDARY OBJECTIVES:

I. To develop both systems so that they may be easily adapted in the future to other therapies that require compliance monitoring.

OUTLINE:

Patient lab and visit dates are monitored by the Cancer Center ORIS and EPIC based systems during the 42 days of the concurrent temozolomide and radiation therapy.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-11
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• All patients who receive concurrent temozolomide and radiation therapy for newly diagnosed malignant gliomas during and after the construction of the system until the end of the study

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Exclusion Criteria

• Patients participating in clinical trials or other deviations from standard therapies that engender similar monitoring risk will be evaluated for this study on a case by case basis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (medical chart review)	Medical Chart Review	Patient lab and visit dates are monitored by the Cancer Center ORIS and EPIC based systems during the 42 days of the concurrent temozolomide and radiation therapy.

Primary Outcome Measures

Name	Time	Method
Frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) generated with the new system	42 days	To compare the two systems, the McNemar's tests of paired proportions will be used. For each day, whether or not any flag (laboratory date flags, visit date flags and in-patient status flags) was generated or whether a gap occurred will be characterized. By day, the two systems will be compared to determine if they agree for flags and gap days (separately). Alternative methods will be used (such as conditional logistic regression with a random subject effect) if correlation between days is observed.
Non-adherent days generated with the new system	42 Days	To compare the two systems, the McNemar's tests of paired proportions will be used. For each day, whether or not any flag (laboratory date flags, visit date flags and in-patient status flags) was generated or whether a gap occurred will be characterized. By day, the two systems will be compared to determine if they agree for flags and gap days (separately). Alternative methods will be used (such as conditional logistic regression with a random subject effect) if correlation between days is observed.
Development of a new adherence monitoring system within Epic that is functionally equivalent to the previously designed and validated system in the Cancer Center ORIS	42 days	To compare the two systems, the McNemar's tests of paired proportions will be used to compare the output of the established software system to the new system built into the EMR reporting structure.

Secondary Outcome Measures

Name	Time	Method
Expansion of both systems to other therapies that require compliance monitoring	42 days	The feasibility of expanding the systems scope to other disease/treatment scenarios that require compliance monitoring.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States