NCT02375334

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 3, 2018

Status Verified

June 1, 2018

Enrollment Period

1.9 years

First QC Date

February 11, 2015

Last Update Submit

June 29, 2018

Conditions

Malignant GliomaMyelosuppression

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Expansion of both systems to other therapies that require compliance monitoring

    42 days

Study Arms (1)

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

Interventions

Medical Chart ReviewOTHER

Medical chart review by the Cancer Center ORIS and EPIC based systems

Also known as: Chart Review
Observational (medical chart review)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Glenn Lesser

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2015

First Posted

March 2, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 3, 2018

Record last verified: 2018-06

Locations

US(1)