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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02375334
Other study ID # IRB00013273
Secondary ID NCI-2015-00113CC
Status Terminated
Phase
First received
Last updated
Start date February 2015
Est. completion date January 2017

Study information

Verified date June 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Medical Chart Review
Medical chart review by the Cancer Center ORIS and EPIC based systems

Locations

Country Name City State
United States Comprehensive Cancer Center of Wake Forest University Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Primary Frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) generated with the new system 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
Primary Non-adherent days generated with the new system 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 Expansion of both systems to other therapies that require compliance monitoring The feasibility of expanding the systems scope to other disease/treatment scenarios that require compliance monitoring. 42 days
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