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

June 29, 2018 updated by: Wake Forest University Health Sciences

Comparative Development of Data Driven Systems for Insuring Timely Monitoring for Brain Tumor Patients for Management of Myelosuppression

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

18

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

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who receive concurrent temozolomide and radiation therapy for newly diagnosed malignant gliomas

Description

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

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (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.
Other: Medical Chart Review
Medical chart review by the Cancer Center ORIS and EPIC based systems
Other Names:
  • Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
42 days
Frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) generated with the new system
Time Frame: 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.
42 days
Non-adherent days generated with the new system
Time Frame: 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.
42 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expansion of both systems to other therapies that require compliance monitoring
Time Frame: 42 days
The feasibility of expanding the systems scope to other disease/treatment scenarios that require compliance monitoring.
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

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

February 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00013273
  • P30CA012197 (U.S. NIH Grant/Contract)
  • NCI-2015-00113 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CCCWFU 99115
  • CCCWFU # 99115 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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