<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/NCT02226497</url>
  </required_header>
  <id_info>
    <org_study_id>9105</org_study_id>
    <secondary_id>NCI-2014-01680</secondary_id>
    <secondary_id>FHCRC #9105</secondary_id>
    <secondary_id>9105</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <nct_id>NCT02226497</nct_id>
  </id_info>
  <brief_title>Telemonitoring Device in Managing Outpatient Care of Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia After Intensive Chemotherapy</brief_title>
  <official_title>Integrating a Telemonitoring Device Into the Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML: A Randomized Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized pilot clinical trial studies a home telemonitoring device in managing the&#xD;
      care of patients with myelodysplastic syndrome or acute myeloid leukemia after they are&#xD;
      discharged from the hospital following chemotherapy. After treatment and hospital discharge,&#xD;
      patients typically need extensive care to deal with the side effects of chemotherapy, keep up&#xD;
      with medications, and obtain medical assistance. A home telemonitoring device would allow&#xD;
      patients to monitor vital signs, symptoms, and use of medications, communicate with&#xD;
      healthcare providers, and access educational material. A telemonitoring device may allow&#xD;
      patients to be managed more effectively than standard outpatient care after being discharged&#xD;
      from the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the feasibility of home telemonitoring for adult patients following intensive&#xD;
      induction, re-induction/salvage, or consolidation chemotherapy for myelodysplastic syndrome&#xD;
      (MDS) or non-acute promyelocytic leukemia (APL) acute myeloid leukemia (AML).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To estimate the impact of the telemonitoring intervention on mortality, duration of&#xD;
      hospital stay, use of emergency services, visits to primary care physicians and to&#xD;
      specialists, home visits, and telephone calls (&quot;health care resource utilization&quot;).&#xD;
&#xD;
      II. To evaluate the telemonitoring procedure in economic terms compared to usual care through&#xD;
      a cost-effectiveness analysis.&#xD;
&#xD;
      III. To estimate the impact on the quality of life of study participating.&#xD;
&#xD;
      IV. To assess the degree of satisfaction of the patients/caregivers and health care&#xD;
      professionals with the telemonitoring intervention.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I (CONTROL): Patients receive standard outpatient supportive care after completion of&#xD;
      chemotherapy.&#xD;
&#xD;
      ARM II (INTERVENTION): Patients receive standard outpatient supportive care as in Arm I and&#xD;
      use the home telemonitoring device for the duration of chemotherapy-induced cytopenia (up to&#xD;
      3-4 weeks).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient staff&#xD;
  </why_stopped>
  <start_date type="Actual">January 9, 2015</start_date>
  <completion_date type="Actual">August 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients willing to use the in-home telemonitoring device</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Exploratory, descriptive and observational methods will be used to determine enrollment and retention issues in AML/MDS patients who are discharged early after intensive chemotherapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Success of data transmission</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Exploratory, descriptive, and observational methods will be used to determine the ability to remotely monitor this patient population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in patient conditions</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Researchers' ability to use the transmitted data to support patients in recognizing changes in their conditions and managing the changes or getting appropriate medical assistance will be estimated between study arms using exploratory, descriptive, and observational methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of satisfaction of the patients/caregivers with the telemonitoring intervention</measure>
    <time_frame>Up to 4 weeks (at end of study period)</time_frame>
    <description>Exploratory, descriptive, and observational methods will be used to estimate differences between the study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of satisfaction of health care professionals with the telemonitoring intervention</measure>
    <time_frame>Up to 4 weeks (at end of study period)</time_frame>
    <description>Exploratory, descriptive, and observational methods will be used to estimate differences between the study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL) as assessed by the M.D. Anderson Symptom Inventory Core items and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30</measure>
    <time_frame>Up to 4 weeks (at end of study period)</time_frame>
    <description>Exploratory, descriptive, and observational methods will be used to estimate in the impact of the telemonitoring intervention on QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of returned surveys</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Percentage of returned surveys will be measured as a feasibility outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The impact of the telemonitoring intervention on mortality compared to the control group will be estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care resource utilization</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Descriptive and observational methods will be used to estimate the impact of the telemonitoring intervention with regard to health care resource utilization, and data on rehospitalization (frequency, duration, resource use, and need for intensive care unit-level care).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Myelodysplastic Syndrome</condition>
  <arm_group>
    <arm_group_label>Arm I (standard outpatient supportive care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive standard outpatient supportive care after completion of chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (home telemonitoring device)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive standard outpatient supportive care as in Arm I and use the home telemonitoring device for the duration of chemotherapy-induced cytopenia (up to 3-4 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Health Telemonitoring</intervention_name>
    <description>Use home telemonitoring device</description>
    <arm_group_label>Arm II (home telemonitoring device)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (standard outpatient supportive care)</arm_group_label>
    <arm_group_label>Arm II (home telemonitoring device)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (standard outpatient supportive care)</arm_group_label>
    <arm_group_label>Arm II (home telemonitoring device)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Supportive Care</intervention_name>
    <description>Receive standard outpatient supportive care</description>
    <arm_group_label>Arm I (standard outpatient supportive care)</arm_group_label>
    <arm_group_label>Arm II (home telemonitoring device)</arm_group_label>
    <other_name>Supportive Therapy</other_name>
    <other_name>Symptom Management</other_name>
    <other_name>Therapy, Supportive</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of MDS or AML other than APL with t(15;17)(q22;q12), (promyelocytic&#xD;
             leukemia[PML]/retinoic acid receptor [RAR]), or variants according to the 2008 World&#xD;
             Health Organization (WHO) classification&#xD;
&#xD;
          -  Patient is currently undergoing AML-like intensive induction, re-induction/salvage, or&#xD;
             consolidation chemotherapy, or planned to start such therapy within 1 week&#xD;
&#xD;
          -  Willingness to have close follow-up and treatment at the Clinic at the Seattle Cancer&#xD;
             Care Alliance (SCCA) or at a local facility; typically, patients will be seen at least&#xD;
             3 times per week as per standard practice, including at least once weekly at the SCCA&#xD;
&#xD;
          -  Permanent or temporary housing available within a 60 minute (min) commute from the&#xD;
             SCCA&#xD;
&#xD;
          -  Available caregiver&#xD;
&#xD;
          -  Willingness and ability to use the telemonitoring device&#xD;
&#xD;
          -  Provision of written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Halpern</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</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>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</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/NCT02226497
org study id: 9105
secondary id: NCI-2014-01680
secondary id: FHCRC #9105
secondary id: 9105
secondary id: P30CA015704
nct id: NCT02226497
lead sponsor: 
collaborator: 
has dmc: No
This randomized pilot clinical trial studies a home telemonitoring device in managing the
      care of patients with myelodysplastic syndrome or acute myeloid leukemia after they are
      discharged from the hospital following chemotherapy. After treatment and hospital discharge,
      patients typically need extensive care to deal with the side effects of chemotherapy, keep up
      with medications, and obtain medical assistance. A home telemonitoring device would allow
      patients to monitor vital signs, symptoms, and use of medications, communicate with
      healthcare providers, and access educational material. A telemonitoring device may allow
      patients to be managed more effectively than standard outpatient care after being discharged
      from the hospital.
PRIMARY OBJECTIVES:

      I. To determine the feasibility of home telemonitoring for adult patients following intensive
      induction, re-induction/salvage, or consolidation chemotherapy for myelodysplastic syndrome
      (MDS) or non-acute promyelocytic leukemia (APL) acute myeloid leukemia (AML).

      SECONDARY OBJECTIVES:

      I. To estimate the impact of the telemonitoring intervention on mortality, duration of
      hospital stay, use of emergency services, visits to primary care physicians and to
      specialists, home visits, and telephone calls ("health care resource utilization").

      II. To evaluate the telemonitoring procedure in economic terms compared to usual care through
      a cost-effectiveness analysis.

      III. To estimate the impact on the quality of life of study participating.

      IV. To assess the degree of satisfaction of the patients/caregivers and health care
      professionals with the telemonitoring intervention.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I (CONTROL): Patients receive standard outpatient supportive care after completion of
      chemotherapy.

      ARM II (INTERVENTION): Patients receive standard outpatient supportive care as in Arm I and
      use the home telemonitoring device for the duration of chemotherapy-induced cytopenia (up to
      3-4 weeks).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Proportion of patients willing to use the in-home telemonitoring device
time frame: Up to 4 weeks
description: Exploratory, descriptive and observational methods will be used to determine enrollment and retention issues in AML/MDS patients who are discharged early after intensive chemotherapy.
measure: Success of data transmission
time frame: Up to 4 weeks
description: Exploratory, descriptive, and observational methods will be used to determine the ability to remotely monitor this patient population.
measure: Changes in patient conditions
time frame: Up to 4 weeks
description: Researchers' ability to use the transmitted data to support patients in recognizing changes in their conditions and managing the changes or getting appropriate medical assistance will be estimated between study arms using exploratory, descriptive, and observational methods.
measure: Degree of satisfaction of the patients/caregivers with the telemonitoring intervention
time frame: Up to 4 weeks (at end of study period)
description: Exploratory, descriptive, and observational methods will be used to estimate differences between the study arms.
measure: Degree of satisfaction of health care professionals with the telemonitoring intervention
time frame: Up to 4 weeks (at end of study period)
description: Exploratory, descriptive, and observational methods will be used to estimate differences between the study arms.
measure: Quality of life (QOL) as assessed by the M.D. Anderson Symptom Inventory Core items and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30
time frame: Up to 4 weeks (at end of study period)
description: Exploratory, descriptive, and observational methods will be used to estimate in the impact of the telemonitoring intervention on QOL.
measure: Percentage of returned surveys
time frame: Up to 4 weeks
description: Percentage of returned surveys will be measured as a feasibility outcome.
measure: Mortality
time frame: Up to 4 weeks
description: The impact of the telemonitoring intervention on mortality compared to the control group will be estimated.
measure: Health care resource utilization
time frame: Up to 4 weeks
description: Descriptive and observational methods will be used to estimate the impact of the telemonitoring intervention with regard to health care resource utilization, and data on rehospitalization (frequency, duration, resource use, and need for intensive care unit-level care).
arm group label: Arm I (standard outpatient supportive care)
arm group type: Active Comparator
description: Patients receive standard outpatient supportive care after completion of chemotherapy.
arm group label: Arm II (home telemonitoring device)
arm group type: Experimental
description: Patients receive standard outpatient supportive care as in Arm I and use the home telemonitoring device for the duration of chemotherapy-induced cytopenia (up to 3-4 weeks).
intervention type: Device
intervention name: Health Telemonitoring
description: Use home telemonitoring device
arm group label: Arm II (home telemonitoring device)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm I (standard outpatient supportive care)
arm group label: Arm II (home telemonitoring device)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (standard outpatient supportive care)
arm group label: Arm II (home telemonitoring device)
intervention type: Procedure
intervention name: Supportive Care
description: Receive standard outpatient supportive care
arm group label: Arm I (standard outpatient supportive care)
arm group label: Arm II (home telemonitoring device)
other name: Supportive Therapy
other name: Symptom Management
other name: Therapy, Supportive
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Anna Halpern
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome