<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/NCT04480541</url>
  </required_header>
  <id_info>
    <org_study_id>UMCC 2020.040</org_study_id>
    <secondary_id>HUM00176584</secondary_id>
    <nct_id>NCT04480541</nct_id>
  </id_info>
  <brief_title>A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients</brief_title>
  <official_title>A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan Rogel Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan Rogel Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the use of a mobile health app (Roadmap 2.0) intervention in&#xD;
      caregivers of patients with cancer. In this study participants will be given the Roadmap 2.0&#xD;
      app, with a focus on the positive aspects of caregiving (positive activity components), and a&#xD;
      Fitbit. The primary objective of this pilot study is to test the feasibility and&#xD;
      acceptability of using the mobile health app.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Health information technology tools may enable caregivers and patients to become more active&#xD;
      participants in their healthcare.This study is not to provide any treatment, but rather to&#xD;
      investigate the use of this mobile health technology-mediated intervention (Roadmap 2.0).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 18, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Roadmap 2.0 login rate</measure>
    <time_frame>Day 120</time_frame>
    <description>Percentage of participants (caregivers and patients) who login to Roadmap 2.0 at least 2 times per week for at least 50% of the study duration (120 days). Login data will be collected by the Roadmap 2.0 software. Qualitative and quantitative analysis will be conducted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Enrollment rate</measure>
    <time_frame>At time of enrollment</time_frame>
    <description>Percentage of participants (caregivers and patients) enrolled in the study, of the total number approached for enrollment. Qualitative and quantitative analysis will be conducted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survey completion rate</measure>
    <time_frame>Day 120</time_frame>
    <description>Percentage of participants (caregivers and patients) who complete all 3 surveys at each of 3 designated time points: Day 0, day 30 and day 120.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cancer</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Roadmap 2.0 + Fitbit Charge 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caregivers and patients download the Roadmap 2.0 mobile app on their own mobile phones or tablet to use freely throughout the 120 day study period.&#xD;
Caregivers and patients receive a Fitbit wearable activitiy sensor to track activity and sleep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Roadmap 2.0 information system</intervention_name>
    <description>Caregivers and patients download the Roadmap 2.0 app on their own mobile phones/tablet</description>
    <arm_group_label>Roadmap 2.0 + Fitbit Charge 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wearable activity sensor</intervention_name>
    <description>Caregivers and patients will receive a Fitbit wearable activity sensor</description>
    <arm_group_label>Roadmap 2.0 + Fitbit Charge 3</arm_group_label>
    <other_name>Fitbit Charge 3</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey administration</intervention_name>
    <description>Caregivers and patients will be asked to complete health-related quality of life surveys</description>
    <arm_group_label>Roadmap 2.0 + Fitbit Charge 3</arm_group_label>
    <other_name>PROMIS®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The caregiver must have an eligible patient (defined in items 5 - 9, below)&#xD;
&#xD;
          2. The caregiver must be of age ≥18 years.&#xD;
&#xD;
          3. The caregiver should be comfortable in reading and speaking English and signing&#xD;
             informed consents.&#xD;
&#xD;
          4. The caregiver should provide at least 50% of care needs.&#xD;
&#xD;
          5. An eligible patient is one who identifies the eligible caregiver as their primary&#xD;
             caregiver (i.e., provides at least 50% of care needs). The caregiver who provides&#xD;
             consent will be deemed the caregiver who participates in the study. In adolescents who&#xD;
             are at the age to provide assent, she/he will designate the caregiver who provides&#xD;
             &gt;50% of their care, and that caregiver will sign the consent document.&#xD;
&#xD;
          6. An eligible patient is age ≥5 years.&#xD;
&#xD;
          7. An eligible patient is able to sign informed consent/assent forms.&#xD;
&#xD;
          8. Patients and caregivers agree to provide informed consent that is in regulatory&#xD;
             compliance and IRBMED-approved.&#xD;
&#xD;
          9. The caregiver and patient must have his/her own smartphone or tablet to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sung Won Choi, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Rogel Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sung Won Choi, MD, MS</last_name>
    <phone>734-615-5707</phone>
    <email>sungchoi@med.umich.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Michigan Rogel Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mobile Health Technology</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04480541
org study id: UMCC 2020.040
secondary id: HUM00176584
nct id: NCT04480541
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will investigate the use of a mobile health app (Roadmap 2.0) intervention in
      caregivers of patients with cancer. In this study participants will be given the Roadmap 2.0
      app, with a focus on the positive aspects of caregiving (positive activity components), and a
      Fitbit. The primary objective of this pilot study is to test the feasibility and
      acceptability of using the mobile health app.
Health information technology tools may enable caregivers and patients to become more active
      participants in their healthcare.This study is not to provide any treatment, but rather to
      investigate the use of this mobile health technology-mediated intervention (Roadmap 2.0).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Roadmap 2.0 login rate
time frame: Day 120
description: Percentage of participants (caregivers and patients) who login to Roadmap 2.0 at least 2 times per week for at least 50% of the study duration (120 days). Login data will be collected by the Roadmap 2.0 software. Qualitative and quantitative analysis will be conducted.
measure: Enrollment rate
time frame: At time of enrollment
description: Percentage of participants (caregivers and patients) enrolled in the study, of the total number approached for enrollment. Qualitative and quantitative analysis will be conducted.
measure: Survey completion rate
time frame: Day 120
description: Percentage of participants (caregivers and patients) who complete all 3 surveys at each of 3 designated time points: Day 0, day 30 and day 120.
arm group label: Roadmap 2.0 + Fitbit Charge 3
arm group type: Experimental
description: Caregivers and patients download the Roadmap 2.0 mobile app on their own mobile phones or tablet to use freely throughout the 120 day study period.
Caregivers and patients receive a Fitbit wearable activitiy sensor to track activity and sleep.
intervention type: Behavioral
intervention name: Roadmap 2.0 information system
description: Caregivers and patients download the Roadmap 2.0 app on their own mobile phones/tablet
arm group label: Roadmap 2.0 + Fitbit Charge 3
intervention type: Other
intervention name: Wearable activity sensor
description: Caregivers and patients will receive a Fitbit wearable activity sensor
arm group label: Roadmap 2.0 + Fitbit Charge 3
other name: Fitbit Charge 3
intervention type: Other
intervention name: Survey administration
description: Caregivers and patients will be asked to complete health-related quality of life surveys
arm group label: Roadmap 2.0 + Fitbit Charge 3
other name: PROMIS®
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: Sung Won Choi, MD, MS
role: Principal Investigator
affiliation: University of Michigan Rogel Cancer Center
last name: Sung Won Choi, MD, MS
phone: 734-615-5707
email: sungchoi@med.umich.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
sharing ipd: No