<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/NCT03809130</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0175</org_study_id>
    <secondary_id>NCI-2018-02992</secondary_id>
    <secondary_id>2018-0175</secondary_id>
    <nct_id>NCT03809130</nct_id>
  </id_info>
  <brief_title>Effectiveness of an Online Intervention Targeting Cancer-related Fatigue</brief_title>
  <official_title>Effectiveness of a Newly Developed Online Intervention on Alleviating Cancer-Related Fatigue in Patients and Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson 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>M.D. Anderson Cancer Center</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 trial studies how well Untire application intervention works in reducing cancer-related&#xD;
      fatigue in cancer patients and survivors.The Untire application focuses on themes that have&#xD;
      been identified as causing or contributing to cancer-related fatigue. It may provide&#xD;
      information and tips to improve lifestyle, give exercises for body and mind to increase&#xD;
      energy levels, offer weekly reports to measure progress, and offer access to an online&#xD;
      support community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the effectiveness of an online multidisciplinary psychological training program&#xD;
      delivered via a smartphone-based application (the Untire app) in reducing patient-reported&#xD;
      fatigue in cancer patients and survivors.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the dose-response association between use of the Untire app and reduction in&#xD;
      patient-reported fatigue severity.&#xD;
&#xD;
      II. To explore whether changes in positive and negative affect, depressive symptoms interact&#xD;
      with the effects of the Untire app on fatigue severity.&#xD;
&#xD;
      III. To explore the predictive value of genetic markers (single-nucleotide polymorphisms) and&#xD;
      personality characteristics for effectiveness of the Untire app in reducing patient-reported&#xD;
      fatigue.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients use Untire application intervention after baseline up to 6 months.&#xD;
&#xD;
      ARM II: Patients use Untire application intervention after 3 months up to 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated Per PI&#xD;
  </why_stopped>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">June 20, 2019</completion_date>
  <primary_completion_date type="Actual">June 20, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in patient-reported fatigue severity as assessed with the Checklist Individual Strength (CIS) between T0 and T1</measure>
    <time_frame>Baseline up to 3 months</time_frame>
    <description>The effect of the intervention on fatigue will be analyzed with a generalized linear model, including CIS-20 sum score at T1 as the dependent variable, CIS-20 sum score at T0 as covariate, and group (intervention versus wait-list control) as independent variable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total days on which the patient logged in to the app</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Change in fatigue between T0 and T1 for the intervention group and between T1 and T2 for the wait-list control group will be entered as dependent variable in multiple regression models, with group allocation as covariate. Separate models will be computed including the different app-usage metrics assessed between T0 -T1 for the intervention group and T1-T2 for the control group as independent variable. These models will additionally be calculated for change in fatigue and use of the app between T0 and T2, for patients in the intervention arm only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of activities completed on the app</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Change in fatigue between T0 and T1 for the intervention group and between T1 and T2 for the wait-list control group will be entered as dependent variable in multiple regression models, with group allocation as covariate. Separate models will be computed including the different app-usage metrics assessed between T0 -T1 for the intervention group and T1-T2 for the control group as independent variable. These models will additionally be calculated for change in fatigue and use of the app between T0 and T2, for patients in the intervention arm only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of completed assessments on the app</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Change in fatigue between T0 and T1 for the intervention group and between T1 and T2 for the wait-list control group will be entered as dependent variable in multiple regression models, with group allocation as covariate. Separate models will be computed including the different app-usage metrics assessed between T0 -T1 for the intervention group and T1-T2 for the control group as independent variable. These models will additionally be calculated for change in fatigue and use of the app between T0 and T2, for patients in the intervention arm only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in negative affect (delta-NA) between T0-T1</measure>
    <time_frame>Baseline up to 3 months</time_frame>
    <description>The linear model described for the primary objective will be repeated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in positive affect (delta (PA) between T0-T1</measure>
    <time_frame>Baseline up to 3 months</time_frame>
    <description>The linear model described for the primary objective will be repeated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depressive symptoms (delta-depr) between T0 and T1</measure>
    <time_frame>Baseline up to 3 months</time_frame>
    <description>The linear model described for the primary objective will be repeated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personality traits</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Personality traits and their interaction with group will be added as independent variables to the linear model described for the primary objective.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genotypes</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Genotypes will be dichotomized (presence of minority alleles in the gene of interest) and added as covariates and in interaction with group to the models.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Cancer Survivor</condition>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Arm I (Untire application)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients use Untire application intervention after baseline up to 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (Untire application)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients use Untire application intervention after 3 months up to 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-Based Intervention</intervention_name>
    <description>Use Untire application after baseline up to 6 months</description>
    <arm_group_label>Arm I (Untire application)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-Based Intervention</intervention_name>
    <description>Use Untire application after 3 months up to 6 months</description>
    <arm_group_label>Arm II (Untire application)</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 (Untire application)</arm_group_label>
    <arm_group_label>Arm II (Untire application)</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 (Untire application)</arm_group_label>
    <arm_group_label>Arm II (Untire application)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who present at the Cancer-Related Fatigue Clinic or the Psychiatric Oncology&#xD;
             Clinic for an initial consult&#xD;
&#xD;
          -  Patients who speak and read English&#xD;
&#xD;
          -  Patients who are willing and able to review, understand, and provide written consent&#xD;
&#xD;
          -  Patients who agree to comply with all study procedures&#xD;
&#xD;
          -  Patients who are in possession of a smartphone or tablet that supports the Untire app&#xD;
             software&#xD;
&#xD;
          -  Patients rating their current fatigue severity as moderate to severe (= or &gt; 4 on a&#xD;
             0-10 scale), assessed as part of the clinics' screening procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Case report of diagnosis of a formal thought disorder (e.g., schizophrenia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cobi J Heijnen</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 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>Neoplasms</mesh_term>
    <mesh_term>Fatigue</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/NCT03809130
org study id: 2018-0175
secondary id: NCI-2018-02992
secondary id: 2018-0175
nct id: NCT03809130
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial studies how well Untire application intervention works in reducing cancer-related
      fatigue in cancer patients and survivors.The Untire application focuses on themes that have
      been identified as causing or contributing to cancer-related fatigue. It may provide
      information and tips to improve lifestyle, give exercises for body and mind to increase
      energy levels, offer weekly reports to measure progress, and offer access to an online
      support community.
PRIMARY OBJECTIVES:

      I. To assess the effectiveness of an online multidisciplinary psychological training program
      delivered via a smartphone-based application (the Untire app) in reducing patient-reported
      fatigue in cancer patients and survivors.

      SECONDARY OBJECTIVES:

      I. To determine the dose-response association between use of the Untire app and reduction in
      patient-reported fatigue severity.

      II. To explore whether changes in positive and negative affect, depressive symptoms interact
      with the effects of the Untire app on fatigue severity.

      III. To explore the predictive value of genetic markers (single-nucleotide polymorphisms) and
      personality characteristics for effectiveness of the Untire app in reducing patient-reported
      fatigue.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients use Untire application intervention after baseline up to 6 months.

      ARM II: Patients use Untire application intervention after 3 months up to 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in patient-reported fatigue severity as assessed with the Checklist Individual Strength (CIS) between T0 and T1
time frame: Baseline up to 3 months
description: The effect of the intervention on fatigue will be analyzed with a generalized linear model, including CIS-20 sum score at T1 as the dependent variable, CIS-20 sum score at T0 as covariate, and group (intervention versus wait-list control) as independent variable.
measure: Total days on which the patient logged in to the app
time frame: Up to 6 months
description: Change in fatigue between T0 and T1 for the intervention group and between T1 and T2 for the wait-list control group will be entered as dependent variable in multiple regression models, with group allocation as covariate. Separate models will be computed including the different app-usage metrics assessed between T0 -T1 for the intervention group and T1-T2 for the control group as independent variable. These models will additionally be calculated for change in fatigue and use of the app between T0 and T2, for patients in the intervention arm only.
measure: Total number of activities completed on the app
time frame: Up to 6 months
description: Change in fatigue between T0 and T1 for the intervention group and between T1 and T2 for the wait-list control group will be entered as dependent variable in multiple regression models, with group allocation as covariate. Separate models will be computed including the different app-usage metrics assessed between T0 -T1 for the intervention group and T1-T2 for the control group as independent variable. These models will additionally be calculated for change in fatigue and use of the app between T0 and T2, for patients in the intervention arm only.
measure: Total number of completed assessments on the app
time frame: Up to 6 months
description: Change in fatigue between T0 and T1 for the intervention group and between T1 and T2 for the wait-list control group will be entered as dependent variable in multiple regression models, with group allocation as covariate. Separate models will be computed including the different app-usage metrics assessed between T0 -T1 for the intervention group and T1-T2 for the control group as independent variable. These models will additionally be calculated for change in fatigue and use of the app between T0 and T2, for patients in the intervention arm only.
measure: Change in negative affect (delta-NA) between T0-T1
time frame: Baseline up to 3 months
description: The linear model described for the primary objective will be repeated.
measure: Change in positive affect (delta (PA) between T0-T1
time frame: Baseline up to 3 months
description: The linear model described for the primary objective will be repeated.
measure: Change in depressive symptoms (delta-depr) between T0 and T1
time frame: Baseline up to 3 months
description: The linear model described for the primary objective will be repeated.
measure: Personality traits
time frame: Up to 6 months
description: Personality traits and their interaction with group will be added as independent variables to the linear model described for the primary objective.
measure: Genotypes
time frame: Up to 6 months
description: Genotypes will be dichotomized (presence of minority alleles in the gene of interest) and added as covariates and in interaction with group to the models.
arm group label: Arm I (Untire application)
arm group type: Experimental
description: Patients use Untire application intervention after baseline up to 6 months.
arm group label: Arm II (Untire application)
arm group type: Active Comparator
description: Patients use Untire application intervention after 3 months up to 6 months.
intervention type: Other
intervention name: Internet-Based Intervention
description: Use Untire application after baseline up to 6 months
arm group label: Arm I (Untire application)
intervention type: Other
intervention name: Internet-Based Intervention
description: Use Untire application after 3 months up to 6 months
arm group label: Arm II (Untire application)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm I (Untire application)
arm group label: Arm II (Untire application)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (Untire application)
arm group label: Arm II (Untire application)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cobi J Heijnen
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Fatigue