<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02208336</url>
  </required_header>
  <id_info>
    <org_study_id>CCCWFU 99210</org_study_id>
    <secondary_id>NCI-2014-01602</secondary_id>
    <secondary_id>CCCWFU 99210</secondary_id>
    <secondary_id>P30CA012197</secondary_id>
    <nct_id>NCT02208336</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <official_title>Evaluation of a Data Driven System for Insuring Timely Monitoring for Brain Tumor Patients for Management of Myelosuppression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research trial studies electronic medical record review in monitoring the effects of&#xD;
      adherence on myelosuppression and morbidity in patients with newly diagnosed brain tumors&#xD;
      receiving temozolomide and radiation therapy. Myelosuppression is a condition in which bone&#xD;
      marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and&#xD;
      platelets and is a side effect of some cancer treatments. Morbidity is a term that refers to&#xD;
      having a symptom of disease or medical problems caused by a treatment. Monitoring patients'&#xD;
      electronic medical records to compare side effects, such as myelosuppression and morbidity,&#xD;
      with treatment adherence may be a way to enhance patient care by organizing data for medical&#xD;
      staff.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Retrospectively measure the frequency of nonadherence with established monitoring&#xD;
      guidelines in the target patient population.&#xD;
&#xD;
      II. Retrospectively assess the impact of nonadherence events on myelosuppression severity and&#xD;
      patient morbidity.&#xD;
&#xD;
      III. Prospectively measure the effect of an automated notification program on adherence&#xD;
      rates.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Quantify any time savings realized by patient care staff through the use of such a&#xD;
      program.&#xD;
&#xD;
      II. Quantify the number of patient care interventions that directly result from this&#xD;
      automated monitoring and notification program.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and&#xD;
      patient morbidity retrospectively and prospectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2010</start_date>
  <completion_date type="Actual">February 23, 2015</completion_date>
  <primary_completion_date type="Actual">February 23, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of nonadherence (retrospective)</measure>
    <time_frame>Up to 42 days (completion of treatment)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of nonadherence events on myelosuppression severity (retrospective)</measure>
    <time_frame>Up to 90 days after completion of treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of nonadherence events on patient morbidity (retrospective)</measure>
    <time_frame>Up to 90 days after completion of treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of an automated notification program on adherence rates (prospective)</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Brain Tumor</condition>
  <arm_group>
    <arm_group_label>Observational (electronic medical record review)</arm_group_label>
    <description>Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>medical chart review</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Observational (electronic medical record review)</arm_group_label>
    <other_name>chart review</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Brain Tumor Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  RETROSPECTIVE: All patients seen in Dr. Lesser's clinic who received concurrent&#xD;
             temozolomide and radiation therapy followed by adjuvant temozolomide for newly&#xD;
             diagnosed malignant gliomas from 01/01/07 through 03/31/2010 will be analyzed&#xD;
&#xD;
          -  PROSPECTIVE: All patients seen in Dr. Lesser's clinic who receive concurrent&#xD;
             temozolomide and radiation therapy followed by adjuvant temozolomide for newly&#xD;
             diagnosed malignant gliomas during and after the construction of the system until the&#xD;
             end of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating in clinical trials or other deviations from non-standard&#xD;
             therapies that engender similar monitoring risk will be evaluated for this study on a&#xD;
             case by case basis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glenn Lesser</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Cancer Center of Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>April 17, 2017</last_update_submitted>
  <last_update_submitted_qc>April 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02208336
org study id: CCCWFU 99210
secondary id: NCI-2014-01602
secondary id: CCCWFU 99210
secondary id: P30CA012197
nct id: NCT02208336
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
PRIMARY OBJECTIVES:

      I. 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:

      I. 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.
observational model: Case-Only
time perspective: Prospective
measure: Frequency of nonadherence (retrospective)
time frame: Up to 42 days (completion of treatment)
description: 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.
measure: Impact of nonadherence events on myelosuppression severity (retrospective)
time frame: Up to 90 days after completion of treatment
description: 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.
measure: Impact of nonadherence events on patient morbidity (retrospective)
time frame: Up to 90 days after completion of treatment
description: 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.
measure: Effect of an automated notification program on adherence rates (prospective)
time frame: Up to 6 years
description: 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.
arm group label: Observational (electronic medical record review)
description: Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively.
intervention type: Other
intervention name: medical chart review
description: Ancillary studies
arm group label: Observational (electronic medical record review)
other name: chart review
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Glenn Lesser
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Neoplasms