<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/NCT03761160</url>
  </required_header>
  <id_info>
    <org_study_id>17-692</org_study_id>
    <nct_id>NCT03761160</nct_id>
  </id_info>
  <brief_title>Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy</brief_title>
  <official_title>Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy: A Randomize Pilot Trial in Men Newly Treated With Androgen Deprivation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prostate Cancer Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</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 study seeks to develop and evaluate a mobile health app which aims to provide&#xD;
      patients who are about to initiate androgen deprivation therapy for prostate cancer with an&#xD;
      exercise program and better eating habits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study seeks to develop and evaluate a mobile health app which aims to provide&#xD;
      patients who are about to initiate androgen deprivation therapy for prostate cancer with an&#xD;
      exercise program and better eating habits. The first phase of the research study seeks to&#xD;
      evaluate the experience of the first version of the mobile health app within a group of&#xD;
      participants and what they think of it.&#xD;
&#xD;
      The investigators are interested in how individuals react to the use of a developed mobile&#xD;
      health app and what they think of it.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2019</start_date>
  <completion_date type="Actual">July 10, 2020</completion_date>
  <primary_completion_date type="Actual">January 28, 2020</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>Accumulation of body fat mass</measure>
    <time_frame>2 years</time_frame>
    <description>This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Whole-body lean mass</measure>
    <time_frame>2 years</time_frame>
    <description>This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional lean mass</measure>
    <time_frame>2 years</time_frame>
    <description>This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent fat</measure>
    <time_frame>2 years</time_frame>
    <description>This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated visceral adipose</measure>
    <time_frame>2 years</time_frame>
    <description>This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Application's performance on iOS and Android platforms</measure>
    <time_frame>2 years</time_frame>
    <description>This outcome (for phase 1 of the trial) will be collected in 10 participants through verbal responses and/or computer either by the research coordinator or the participant. All data collected will be anonymously recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Application's ability to effectively motivate and track outcomes for patients</measure>
    <time_frame>2 years</time_frame>
    <description>This outcome (for phase 1 of the trial) will be collected in 10 participants through verbal responses and/or computer either by the research coordinator or the participant. All data collected will be anonymously recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Mobile Health App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The developed mobile health app will include the following facets:&#xD;
Physical activities&#xD;
Dietary regimen.&#xD;
The physical activities facet will encourage patients to engage in physical activities, with daily prompts, encouragement, and tips.&#xD;
Users will be asked to record the type of physical activity they engaged in during the week, and for how long.&#xD;
The dietary aspect will ask patients to log what they ate during the day and to rate how 'healthy' it is</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care per hospital guideline</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Health App</intervention_name>
    <description>mobile health app aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habit</description>
    <arm_group_label>Mobile Health App</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Usual care per hospital guidelines</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Phase 1&#xD;
&#xD;
          -  All recruited participants must have owned a smartphone for &gt;1 year&#xD;
&#xD;
          -  English-speaking.&#xD;
&#xD;
          -  Patients with prostate cancer aged between 40-75 years will be considered.&#xD;
&#xD;
          -  No specific timeframe after prostate cancer diagnosis will be required for these&#xD;
             patients.&#xD;
&#xD;
          -  No limitations regarding their disease characteristics will be imposed (e.g.&#xD;
             metastatic disease).&#xD;
&#xD;
          -  Patients may or may not be currently receiving treatment Staff members will be&#xD;
             recruited from&#xD;
&#xD;
          -  Dana-Farber Cancer Institute Department of Medical Oncology,&#xD;
&#xD;
          -  Brigham and Women's Hospital, Department of Surgery. Staff members aged between 40-75&#xD;
             years old will be considered. Phase 2&#xD;
&#xD;
          -  Men diagnosed with prostate cancer presenting to DF/BWHCC&#xD;
&#xD;
          -  About to initiate ADT for the first time will be considered.&#xD;
&#xD;
          -  Age range 40-75-years&#xD;
&#xD;
          -  The ability to walk 400 m&#xD;
&#xD;
          -  Medical clearance from their primary physician&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Cognitively alert&#xD;
&#xD;
          -  Literate&#xD;
&#xD;
          -  Ability to read or hear with or without contacts/glass and hearing aid&#xD;
&#xD;
          -  Ownership of a smartphone for &gt;1yr&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men who have been under a rigorous structured exercise regime, such as individuals who&#xD;
             engage in more than 900 minutes of moderate physical activity per week in the last 6&#xD;
             months will not be considered&#xD;
&#xD;
          -  Post-ADT treatment&#xD;
&#xD;
          -  Planned systemic chemotherapy&#xD;
&#xD;
          -  Planned treatment with abiraterone or enzalutamide&#xD;
&#xD;
          -  Bone metastases&#xD;
&#xD;
          -  Acute illness&#xD;
&#xD;
          -  Any musculoskeletal, cardiovascular, or neurologic disorders that could inhibit or put&#xD;
             them at risk from exercising&#xD;
&#xD;
          -  Subordinates to the PI&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>QUOC-DIEN TRINH, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 3, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>June 17, 2023</last_update_submitted>
  <last_update_submitted_qc>June 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Quoc-Dien Trinh, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication.</ipd_time_frame>
    <ipd_access_criteria>Requests may be directed to: [contact information for Sponsor- Investigator or designee].</ipd_access_criteria>
  </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/NCT03761160
org study id: 17-692
nct id: NCT03761160
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study seeks to develop and evaluate a mobile health app which aims to provide
      patients who are about to initiate androgen deprivation therapy for prostate cancer with an
      exercise program and better eating habits.
This research study seeks to develop and evaluate a mobile health app which aims to provide
      patients who are about to initiate androgen deprivation therapy for prostate cancer with an
      exercise program and better eating habits. The first phase of the research study seeks to
      evaluate the experience of the first version of the mobile health app within a group of
      participants and what they think of it.

      The investigators are interested in how individuals react to the use of a developed mobile
      health app and what they think of it.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Accumulation of body fat mass
time frame: 2 years
description: This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
measure: Whole-body lean mass
time frame: 2 years
description: This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
measure: Regional lean mass
time frame: 2 years
description: This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
measure: Percent fat
time frame: 2 years
description: This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
measure: Estimated visceral adipose
time frame: 2 years
description: This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
measure: Application's performance on iOS and Android platforms
time frame: 2 years
description: This outcome (for phase 1 of the trial) will be collected in 10 participants through verbal responses and/or computer either by the research coordinator or the participant. All data collected will be anonymously recorded.
measure: Application's ability to effectively motivate and track outcomes for patients
time frame: 2 years
description: This outcome (for phase 1 of the trial) will be collected in 10 participants through verbal responses and/or computer either by the research coordinator or the participant. All data collected will be anonymously recorded.
arm group label: Mobile Health App
arm group type: Experimental
description: The developed mobile health app will include the following facets:
Physical activities
Dietary regimen.
The physical activities facet will encourage patients to engage in physical activities, with daily prompts, encouragement, and tips.
Users will be asked to record the type of physical activity they engaged in during the week, and for how long.
The dietary aspect will ask patients to log what they ate during the day and to rate how 'healthy' it is
arm group label: Usual Care
arm group type: Active Comparator
description: Usual care per hospital guideline
intervention type: Other
intervention name: Mobile Health App
description: mobile health app aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habit
arm group label: Mobile Health App
intervention type: Other
intervention name: Usual care
description: Usual care per hospital guidelines
arm group label: Usual Care
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: QUOC-DIEN TRINH, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Quoc-Dien Trinh, MD
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication.
ipd access criteria: Requests may be directed to: [contact information for Sponsor- Investigator or designee].