Brain TumorNCT02208336
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
An observational study of Brain Tumor, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Tumor
- What is being tested?
- medical chart review
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to 23 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Brain Tumor Patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Brain Tumor
- Being tested
- medical chart review
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
Also called chart review
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (electronic medical record review) | Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively. Receives: Other: medical chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startOct 2010
- Primary completion23 Feb 2015
- Study completion23 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Glenn Lesser, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208336
- Sponsor's protocol ID
- CCCWFU 99210
- Other IDs
- NCI-2014-01602, CCCWFU 99210, P30CA012197
- Status last verified
- Apr 2017
- First submitted
- 1 Aug 2014
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Data Driven System for Insuring Timely Monitoring for Brain Tumor Patients for Management of Myelosuppression
- ClinicalTrials.gov ID
- NCT02208336
- Acronym / sponsor ID
- CCCWFU 99210
- Conditions
- Brain Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2010 (actual)
- Primary completion
- 23 Feb 2015 (actual)
- Study completion
- 23 Feb 2015 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (electronic medical record review) | – | Other: medical chart reviewPatients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Brain Tumor Patients
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical chart reviewAlso: chart reviewAncillary studies | Other | Observational (electronic medical record review) |
Primary outcome
Frequency of nonadherence (retrospective)
Time frame: Up to 42 days (completion of treatment)
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.
Impact of nonadherence events on myelosuppression severity (retrospective)
Time frame: Up to 90 days after completion of treatment
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.
Impact of nonadherence events on patient morbidity (retrospective)
Time frame: Up to 90 days after completion of treatment
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.
Effect of an automated notification program on adherence rates (prospective)
Time frame: Up to 6 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Lesser principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of nonadherence (retrospective) (time frame: Up to 42 days (completion of treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.