<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/NCT03042884</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0671</org_study_id>
    <nct_id>NCT03042884</nct_id>
  </id_info>
  <brief_title>Wearable Exercise Trackers in Cancer Rehabilitation</brief_title>
  <official_title>Wearable Exercise Trackers in Cancer Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      The goal of this research study is to learn how useful a wearable exercise tracker watch is&#xD;
      to monitor your physical activity.&#xD;
&#xD;
      This is an investigational study.&#xD;
&#xD;
      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inpatient:&#xD;
&#xD;
      If you agree to take part in this study, you will complete a questionnaire about any symptoms&#xD;
      you may have had in the past 24 hours. The questionnaire should take about 5 minutes to&#xD;
      complete.&#xD;
&#xD;
      You will receive a wearable exercise tracker watch and an iPod touch. You should wear the&#xD;
      exercise tracker watch on your wrist for 24 hours a day (or as much as possible) while you&#xD;
      are in the acute inpatient rehabilitation unit, even when you sleep. The iPod touch will be&#xD;
      used to sync the data from the tracker watch to the study's activity database so the study&#xD;
      team can view your activity. Instructions on how to use the tracker and how to sync the&#xD;
      trackers to the iPod touch will be given to you and demonstrated by the research staff.&#xD;
&#xD;
      The research coordinator will be available to help you with any issues you may have while&#xD;
      taking part in the study and will call you to answer any questions. You will be called on Day&#xD;
      3 (+/- 2 days) of the study and again at the end of the study. These calls should last about&#xD;
      5 minutes each time.&#xD;
&#xD;
      The wearable tracker will record your steps, sleep time, time spent doing physical activity,&#xD;
      heart rate, and distance. You may choose to record the food you eat and mood. Your ability to&#xD;
      keep wearing the watch will be measured.&#xD;
&#xD;
      You should wear the band loosely enough that it can move back and forth on your wrist. If it&#xD;
      becomes too bothersome, you can take the watch off and put it back on after an hour.&#xD;
&#xD;
      You should regularly clean the band and your wrist, especially after your rehabilitation&#xD;
      sessions. Rinse the band with water or wipe it with a small amount of rubbing alcohol. Do not&#xD;
      use hand soap, body soap, dish soap, hand sanitizers, cleaning wipes or household cleaners&#xD;
      which could get trapped beneath the band and irritate your skin. Always dry the band well&#xD;
      before putting it back on.&#xD;
&#xD;
      If any of the devices are lost, stolen, or broken, you should tell the study staff right&#xD;
      away. They will be replaced at no cost to you as long as you have followed the study doctor's&#xD;
      instructions. After you complete the study, we ask that you return the devices to the study&#xD;
      staff.&#xD;
&#xD;
      Within 24 hours before you are discharged, you will return the devices to the research staff.&#xD;
      You will be asked to complete the same questionnaire about your symptoms and a questionnaire&#xD;
      about your experience with the wearable exercise tracker. These questionnaires should take&#xD;
      about 10 minutes total to complete. If you are unable to complete them in person, you will be&#xD;
      given the option to complete them over the phone or electronically after you have been&#xD;
      discharged. If you choose to complete them electronically, your e-mail address will be&#xD;
      collected so the survey link can be sent to you. We ask that you complete the questionnaires&#xD;
      within 1 week after you are discharged.&#xD;
&#xD;
      Information will be collected from your medical records about your daily living at the&#xD;
      beginning and at the end of the study. Basic information, such as your name, date of birth,&#xD;
      race, gender, economic background, and medical record number will also be collected.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      You participation on this study will be over after you complete the second set of&#xD;
      questionnaires.&#xD;
&#xD;
      Outpatient:&#xD;
&#xD;
      If you agree to take part in this study, you will complete 2 questionnaires about any&#xD;
      symptoms you may have had in the past 24 hours and your current level of physical function.&#xD;
      These should take about 10 minutes total to complete.&#xD;
&#xD;
      You will receive a wearable exercise tracker watch and an iPod touch. You should wear the&#xD;
      exercise tracker watch on your wrist for 24 hours a day (or as much as possible) while you&#xD;
      are in the acute inpatient rehabilitation unit, even when you sleep. The iPod touch will be&#xD;
      used to sync the data from the tracker watch to the study's activity database so the study&#xD;
      team can view your activity. Instructions on how to use the tracker and how to sync the&#xD;
      trackers to the iPod touch will be given to you and demonstrated by the research staff.&#xD;
&#xD;
      The research coordinator will be available to help you with any issues you may have while&#xD;
      taking part in the study and will call you to answer any questions. You will be called on Day&#xD;
      3 (+/- 2 days) of the study and again at the end of the study. These calls should last about&#xD;
      5 minutes each time.&#xD;
&#xD;
      The wearable tracker will record your steps, sleep time, time spent doing physical activity,&#xD;
      heart rate, and distance. You may choose to record the food you eat and mood. Your ability to&#xD;
      keep wearing the watch will be measured. No identifying information will be used on the&#xD;
      devices.&#xD;
&#xD;
      You should wear the band loosely enough that it can move back and forth on your wrist. If it&#xD;
      becomes too bothersome, you can take the watch off and put it back on after an hour.&#xD;
&#xD;
      You should regularly clean the band and your wrist, especially after your rehabilitation&#xD;
      sessions. Rinse the band with water or wipe it with a small amount of rubbing alcohol. Do not&#xD;
      use hand soap, body soap, dish soap, hand sanitizers, cleaning wipes or household cleaners&#xD;
      which could get trapped beneath the band and irritate your skin. Always dry the band well&#xD;
      before putting it back on.&#xD;
&#xD;
      If any of the devices are lost, stolen, or broken, you should tell the study staff right&#xD;
      away. They will be replaced at no cost to you as long as you have followed the study doctor's&#xD;
      instructions. After you complete the study, we ask that you return the devices to the study&#xD;
      staff.&#xD;
&#xD;
      At the end of the 14-day period, you will be called by the study staff to remind you to&#xD;
      complete the same 2 questionnaires about your symptoms and level of physical function. You&#xD;
      will complete another questionnaire about your experience with the wearable exercise tracker.&#xD;
      These questionnaires should take about 15 minutes total to complete.&#xD;
&#xD;
      If you choose to complete these forms electronically, they will be made available online with&#xD;
      a link on the iPod. You may also choose to complete the questionnaires over the phone.&#xD;
&#xD;
      You will be asked to return the wearable tracker and iPod Touch to the research coordinator&#xD;
      at your next routine clinic visit. If you are unable to return to the clinic, you will be&#xD;
      asked to mail back the devices with the FedEx postage paid envelope provided to you when you&#xD;
      started the study.&#xD;
&#xD;
      Basic information, such as your name, date of birth, race, gender, economic background, and&#xD;
      medical record number will also be collected.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      You participation on this study will be over after you complete the second set of&#xD;
      questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Actual">December 14, 2020</completion_date>
  <primary_completion_date type="Actual">December 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usefulness of Exercise Tracker in Acute Inpatient Rehabilitation Unit Per Edmonton Symptom Assessment Scale (ESAS-FS)</measure>
    <time_frame>14 days</time_frame>
    <description>Exercise tracker considered useful if at least 2/3 patients consider it as useful.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usefulness of Exercise Tracker as an Outpatient Per Edmonton Symptom Assessment Scale (ESAS-FS)</measure>
    <time_frame>14 days</time_frame>
    <description>Exercise tracker considered useful if at least 2/3 patients consider it as useful.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usefulness of Exercise Tracker in Acute Inpatient Rehabilitation Unit Per Patient Reported Outcomes Measurement Information System (PROMIS)</measure>
    <time_frame>14 days</time_frame>
    <description>Exercise tracker considered useful if at least 2/3 patients consider it as useful.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usefulness of Exercise Tracker as an Outpatient Per Patient Reported Outcomes Measurement Information System (PROMIS)</measure>
    <time_frame>14 days</time_frame>
    <description>Exercise tracker considered useful if at least 2/3 patients consider it as useful.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Benign Neoplasms</condition>
  <condition>In Situ Neoplasms</condition>
  <condition>Malignant Neoplasms of Independent (Primary) Multiple Sites</condition>
  <arm_group>
    <arm_group_label>Wearable Exercise Trackers - Inpatient Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Questionnaires completed at baseline and within 24 hours of discharge.&#xD;
Participant given a wearable exercise tracker to be worn 24 hours a day while in the acute inpatient rehabilitation unit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wearable Exercise Trackers - Outpatient Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Questionnaires completed at baseline and again in 14 days.&#xD;
Participant given a wearable exercise tracker to be worn 24 hours a day for 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Inpatient Group: Participants complete a questionnaire about any symptoms they may have had in the past 24 hours. The questionnaire should take about 5 minutes to complete.&#xD;
Within 24 hours of being discharged, same questionnaire about symptoms and a questionnaire about experience with the wearable exercise tracker. These questionnaires should take about 10 minutes total to complete.&#xD;
Outpatient Group: Participants complete 2 questionnaires about any symptoms they may have had in the past 24 hours and their current level of physical function. These should take about 10 minutes total to complete.&#xD;
At the end of the 14-day period, participant called by the study staff to remind them to complete the same 2 questionnaires about symptoms and level of physical function. Participants complete another questionnaire about their experience with the wearable exercise tracker. These questionnaires should take about 15 minutes total to complete.</description>
    <arm_group_label>Wearable Exercise Trackers - Inpatient Group</arm_group_label>
    <arm_group_label>Wearable Exercise Trackers - Outpatient Group</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wearable Exercise Tracker Watch</intervention_name>
    <description>Inpatient Group: Participants receive a wearable exercise tracker watch upon admission to acute inpatient rehabilitation unit. Participant to wear the exercise tracker watch on their wrist for 24 hours a day. Device to be returned within 24 hours before being discharged.&#xD;
Outpatient Group: Participants receive a wearable exercise tracker watch to wear on their wrist for 24 hours a day for 14 days. Device to be returned at next visit.</description>
    <arm_group_label>Wearable Exercise Trackers - Inpatient Group</arm_group_label>
    <arm_group_label>Wearable Exercise Trackers - Outpatient Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women with literacy as demonstrated by reading and signing informed consent&#xD;
             form&#xD;
&#xD;
          2. At least 18 years of age, since the rehabilitation unit and physical medicine and&#xD;
             rehabilitation clinic is open to patients 18 years of age or older&#xD;
&#xD;
          3. Patients admitted to the acute inpatient rehabilitation unit and those seen in the&#xD;
             Physical Medicine and Rehabilitation outpatient clinic&#xD;
&#xD;
          4. Capable of completing questionnaire in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Patients currently using a wearable activity tracker&#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>Amy Ng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD 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>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Benign Neoplasms</keyword>
  <keyword>In Situ Neoplasms</keyword>
  <keyword>Malignant Neoplasms of Independent (Primary) Multiple Sites</keyword>
  <keyword>Wearable exercise trackers</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03042884
org study id: 2016-0671
nct id: NCT03042884
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research study is to learn how useful a wearable exercise tracker watch is
      to monitor your physical activity.

      This is an investigational study.

      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
Inpatient:

      If you agree to take part in this study, you will complete a questionnaire about any symptoms
      you may have had in the past 24 hours. The questionnaire should take about 5 minutes to
      complete.

      You will receive a wearable exercise tracker watch and an iPod touch. You should wear the
      exercise tracker watch on your wrist for 24 hours a day (or as much as possible) while you
      are in the acute inpatient rehabilitation unit, even when you sleep. The iPod touch will be
      used to sync the data from the tracker watch to the study's activity database so the study
      team can view your activity. Instructions on how to use the tracker and how to sync the
      trackers to the iPod touch will be given to you and demonstrated by the research staff.

      The research coordinator will be available to help you with any issues you may have while
      taking part in the study and will call you to answer any questions. You will be called on Day
      3 (+/- 2 days) of the study and again at the end of the study. These calls should last about
      5 minutes each time.

      The wearable tracker will record your steps, sleep time, time spent doing physical activity,
      heart rate, and distance. You may choose to record the food you eat and mood. Your ability to
      keep wearing the watch will be measured.

      You should wear the band loosely enough that it can move back and forth on your wrist. If it
      becomes too bothersome, you can take the watch off and put it back on after an hour.

      You should regularly clean the band and your wrist, especially after your rehabilitation
      sessions. Rinse the band with water or wipe it with a small amount of rubbing alcohol. Do not
      use hand soap, body soap, dish soap, hand sanitizers, cleaning wipes or household cleaners
      which could get trapped beneath the band and irritate your skin. Always dry the band well
      before putting it back on.

      If any of the devices are lost, stolen, or broken, you should tell the study staff right
      away. They will be replaced at no cost to you as long as you have followed the study doctor's
      instructions. After you complete the study, we ask that you return the devices to the study
      staff.

      Within 24 hours before you are discharged, you will return the devices to the research staff.
      You will be asked to complete the same questionnaire about your symptoms and a questionnaire
      about your experience with the wearable exercise tracker. These questionnaires should take
      about 10 minutes total to complete. If you are unable to complete them in person, you will be
      given the option to complete them over the phone or electronically after you have been
      discharged. If you choose to complete them electronically, your e-mail address will be
      collected so the survey link can be sent to you. We ask that you complete the questionnaires
      within 1 week after you are discharged.

      Information will be collected from your medical records about your daily living at the
      beginning and at the end of the study. Basic information, such as your name, date of birth,
      race, gender, economic background, and medical record number will also be collected.

      Length of Study:

      You participation on this study will be over after you complete the second set of
      questionnaires.

      Outpatient:

      If you agree to take part in this study, you will complete 2 questionnaires about any
      symptoms you may have had in the past 24 hours and your current level of physical function.
      These should take about 10 minutes total to complete.

      You will receive a wearable exercise tracker watch and an iPod touch. You should wear the
      exercise tracker watch on your wrist for 24 hours a day (or as much as possible) while you
      are in the acute inpatient rehabilitation unit, even when you sleep. The iPod touch will be
      used to sync the data from the tracker watch to the study's activity database so the study
      team can view your activity. Instructions on how to use the tracker and how to sync the
      trackers to the iPod touch will be given to you and demonstrated by the research staff.

      The research coordinator will be available to help you with any issues you may have while
      taking part in the study and will call you to answer any questions. You will be called on Day
      3 (+/- 2 days) of the study and again at the end of the study. These calls should last about
      5 minutes each time.

      The wearable tracker will record your steps, sleep time, time spent doing physical activity,
      heart rate, and distance. You may choose to record the food you eat and mood. Your ability to
      keep wearing the watch will be measured. No identifying information will be used on the
      devices.

      You should wear the band loosely enough that it can move back and forth on your wrist. If it
      becomes too bothersome, you can take the watch off and put it back on after an hour.

      You should regularly clean the band and your wrist, especially after your rehabilitation
      sessions. Rinse the band with water or wipe it with a small amount of rubbing alcohol. Do not
      use hand soap, body soap, dish soap, hand sanitizers, cleaning wipes or household cleaners
      which could get trapped beneath the band and irritate your skin. Always dry the band well
      before putting it back on.

      If any of the devices are lost, stolen, or broken, you should tell the study staff right
      away. They will be replaced at no cost to you as long as you have followed the study doctor's
      instructions. After you complete the study, we ask that you return the devices to the study
      staff.

      At the end of the 14-day period, you will be called by the study staff to remind you to
      complete the same 2 questionnaires about your symptoms and level of physical function. You
      will complete another questionnaire about your experience with the wearable exercise tracker.
      These questionnaires should take about 15 minutes total to complete.

      If you choose to complete these forms electronically, they will be made available online with
      a link on the iPod. You may also choose to complete the questionnaires over the phone.

      You will be asked to return the wearable tracker and iPod Touch to the research coordinator
      at your next routine clinic visit. If you are unable to return to the clinic, you will be
      asked to mail back the devices with the FedEx postage paid envelope provided to you when you
      started the study.

      Basic information, such as your name, date of birth, race, gender, economic background, and
      medical record number will also be collected.

      Length of Study:

      You participation on this study will be over after you complete the second set of
      questionnaires.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Usefulness of Exercise Tracker in Acute Inpatient Rehabilitation Unit Per Edmonton Symptom Assessment Scale (ESAS-FS)
time frame: 14 days
description: Exercise tracker considered useful if at least 2/3 patients consider it as useful.
measure: Usefulness of Exercise Tracker as an Outpatient Per Edmonton Symptom Assessment Scale (ESAS-FS)
time frame: 14 days
description: Exercise tracker considered useful if at least 2/3 patients consider it as useful.
measure: Usefulness of Exercise Tracker in Acute Inpatient Rehabilitation Unit Per Patient Reported Outcomes Measurement Information System (PROMIS)
time frame: 14 days
description: Exercise tracker considered useful if at least 2/3 patients consider it as useful.
measure: Usefulness of Exercise Tracker as an Outpatient Per Patient Reported Outcomes Measurement Information System (PROMIS)
time frame: 14 days
description: Exercise tracker considered useful if at least 2/3 patients consider it as useful.
arm group label: Wearable Exercise Trackers - Inpatient Group
arm group type: Experimental
description: Questionnaires completed at baseline and within 24 hours of discharge.
Participant given a wearable exercise tracker to be worn 24 hours a day while in the acute inpatient rehabilitation unit.
arm group label: Wearable Exercise Trackers - Outpatient Group
arm group type: Experimental
description: Questionnaires completed at baseline and again in 14 days.
Participant given a wearable exercise tracker to be worn 24 hours a day for 14 days.
intervention type: Behavioral
intervention name: Questionnaires
description: Inpatient Group: Participants complete a questionnaire about any symptoms they may have had in the past 24 hours. The questionnaire should take about 5 minutes to complete.
Within 24 hours of being discharged, same questionnaire about symptoms and a questionnaire about experience with the wearable exercise tracker. These questionnaires should take about 10 minutes total to complete.
Outpatient Group: Participants complete 2 questionnaires about any symptoms they may have had in the past 24 hours and their current level of physical function. These should take about 10 minutes total to complete.
At the end of the 14-day period, participant called by the study staff to remind them to complete the same 2 questionnaires about symptoms and level of physical function. Participants complete another questionnaire about their experience with the wearable exercise tracker. These questionnaires should take about 15 minutes total to complete.
arm group label: Wearable Exercise Trackers - Inpatient Group
arm group label: Wearable Exercise Trackers - Outpatient Group
other name: Surveys
intervention type: Device
intervention name: Wearable Exercise Tracker Watch
description: Inpatient Group: Participants receive a wearable exercise tracker watch upon admission to acute inpatient rehabilitation unit. Participant to wear the exercise tracker watch on their wrist for 24 hours a day. Device to be returned within 24 hours before being discharged.
Outpatient Group: Participants receive a wearable exercise tracker watch to wear on their wrist for 24 hours a day for 14 days. Device to be returned at next visit.
arm group label: Wearable Exercise Trackers - Inpatient Group
arm group label: Wearable Exercise Trackers - Outpatient Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amy Ng, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neoplasms