<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/NCT03041545</url>
  </required_header>
  <id_info>
    <org_study_id>150860</org_study_id>
    <secondary_id>5U54CA155435-05</secondary_id>
    <nct_id>NCT03041545</nct_id>
  </id_info>
  <brief_title>Tracking Physical Activity Throughout Chemotherapy for Breast Cancer</brief_title>
  <official_title>Tracking Physical Activity Throughout Chemotherapy for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</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>
      Physical activity during chemotherapy has been shown to increase patient health and wellbeing&#xD;
      as well as improve outcomes in breast cancer patients. The primary aim of this project is to&#xD;
      determine the feasibility of incorporating wearable sensors into clinical care by having&#xD;
      breast cancer patients, undergoing chemotherapy, wear a commercially available monitor&#xD;
      (Fitbit) that tracks physical activity, sleep, and heart rate monitor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although there are many benefits of engaging in physical activity during cancer treatments,&#xD;
      activity levels typically decline throughout treatment. Existing research has primarily&#xD;
      relied on self-reported activity levels and only captured periodic snap shots or&#xD;
      retrospective reports of activity levels, which are subject to recall bias. Exactly how&#xD;
      activity levels change throughout chemotherapy is not known. This study will provide&#xD;
      minute-by-minute level objective physical activity data across the entirety of the patient's&#xD;
      chemotherapy treatments. This in depth data will provide a new perspective on the patterns of&#xD;
      activity levels and help to identify if there are critical times in which to intervene to&#xD;
      prevent declines in physical activity.&#xD;
&#xD;
      The investigators will assess the feasibility of the pre-treatment recruitment by documenting&#xD;
      recruitment rates and participant acceptance of wearing the accelerometer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Actual">February 8, 2018</completion_date>
  <primary_completion_date type="Actual">February 8, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment</measure>
    <time_frame>06/01/2015-06/01/2018</time_frame>
    <description>Enrolling &gt;20% of eligible patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retention</measure>
    <time_frame>From date enrolled into the study until 1 week after the date of the last infusion center visit for chemotherapy, which is typically up to 6 months.</time_frame>
    <description>&gt;80% of participants wore the Fitbit for &gt;80% of the days during chemotherapy treatment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Fitbit</arm_group_label>
    <description>All participants will be asked to wear the Fitbit as much as possible and to sync it at least once a week, from one week prior to start of chemotherapy treatment to six months after ending chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fitbit</intervention_name>
    <description>Women enrolled in the study will be asked to wear a Fitbit from one week prior to chemotherapy until six months post-chemotherapy. The Fitbit is a watch-sized, wrist worn, physical activity tracker. A button, when pressed, displays the wearer's accumulated daily steps, mileage, and steps climbed.</description>
    <arm_group_label>Fitbit</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is all women approached to attempt recruitment. Women will be&#xD;
        recruited through the Medical Oncology Clinics at UCSD Moroes Cancer Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Diagnosed with breast cancer&#xD;
&#xD;
          -  Scheduled to receive chemotherapy, but has not yet started chemotherapy&#xD;
&#xD;
          -  Receiving chemotherapy at a University of California, San Diego clinic&#xD;
&#xD;
          -  Willingness to wear the Fitbit throughout the course of chemotherapy&#xD;
&#xD;
          -  Access to a computer or Bluetooth enabled phone to sync Fitbit data&#xD;
&#xD;
          -  Able to read and communicate in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Serious physical limitation that greatly limits mobility&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheri J Hartman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>June 11, 2018</last_update_submitted>
  <last_update_submitted_qc>June 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Sheri Hartman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03041545
org study id: 150860
secondary id: 5U54CA155435-05
nct id: NCT03041545
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Physical activity during chemotherapy has been shown to increase patient health and wellbeing
      as well as improve outcomes in breast cancer patients. The primary aim of this project is to
      determine the feasibility of incorporating wearable sensors into clinical care by having
      breast cancer patients, undergoing chemotherapy, wear a commercially available monitor
      (Fitbit) that tracks physical activity, sleep, and heart rate monitor.
Although there are many benefits of engaging in physical activity during cancer treatments,
      activity levels typically decline throughout treatment. Existing research has primarily
      relied on self-reported activity levels and only captured periodic snap shots or
      retrospective reports of activity levels, which are subject to recall bias. Exactly how
      activity levels change throughout chemotherapy is not known. This study will provide
      minute-by-minute level objective physical activity data across the entirety of the patient's
      chemotherapy treatments. This in depth data will provide a new perspective on the patterns of
      activity levels and help to identify if there are critical times in which to intervene to
      prevent declines in physical activity.

      The investigators will assess the feasibility of the pre-treatment recruitment by documenting
      recruitment rates and participant acceptance of wearing the accelerometer.
observational model: Cohort
time perspective: Prospective
measure: Recruitment
time frame: 06/01/2015-06/01/2018
description: Enrolling >20% of eligible patients
measure: Retention
time frame: From date enrolled into the study until 1 week after the date of the last infusion center visit for chemotherapy, which is typically up to 6 months.
description: >80% of participants wore the Fitbit for >80% of the days during chemotherapy treatment
arm group label: Fitbit
description: All participants will be asked to wear the Fitbit as much as possible and to sync it at least once a week, from one week prior to start of chemotherapy treatment to six months after ending chemotherapy.
intervention type: Device
intervention name: Fitbit
description: Women enrolled in the study will be asked to wear a Fitbit from one week prior to chemotherapy until six months post-chemotherapy. The Fitbit is a watch-sized, wrist worn, physical activity tracker. A button, when pressed, displays the wearer's accumulated daily steps, mileage, and steps climbed.
arm group label: Fitbit
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: Sheri J Hartman, PhD
role: Principal Investigator
affiliation: Assistant Professor
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Sheri Hartman
investigator title: Assistant Professor
mesh term: Breast Neoplasms
sharing ipd: No