<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/NCT03233581</url>
  </required_header>
  <id_info>
    <org_study_id>Fitbit YA 9865</org_study_id>
    <nct_id>NCT03233581</nct_id>
  </id_info>
  <brief_title>Improving Physical Activity in Young Adult Cancer Survivors</brief_title>
  <official_title>Improving Physical Activity in Young Adult Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's Hospital</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 Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the&#xD;
      Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the&#xD;
      Fitbit mobile health (mHealth) app. The target population will be cancer survivors 18-39&#xD;
      years old recruited from the Seattle Cancer Care Alliance. For the intervention group, peer&#xD;
      influences will be engaged via a private, social network (e.g. a Facebook group) customized&#xD;
      for survivors. Measurements will be completed (1) at baseline, prior to randomization, and&#xD;
      (2) during the final week of the intervention period (follow-up measure). This pilot study&#xD;
      will provide initial proof of concept and allow for further customization of the intervention&#xD;
      for cancer survivors in anticipation of a future, larger proposal to study physical activity&#xD;
      and related outcomes over a multi-year period.&#xD;
&#xD;
      Besides conducting exploratory analyses of primary and secondary outcomes for this pilot RCT,&#xD;
      we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39&#xD;
      years and between 1.0-5.0 years from the completion of active cancer therapy, (2)&#xD;
      intervention participants wear the Fitbit Flex on the majority of all intervention days&#xD;
      during the 12-week intervention period, and (3) ≥75% of all participants complete online&#xD;
      questionnaire data collection at Time 1 and Time 2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">May 22, 2018</completion_date>
  <primary_completion_date type="Actual">May 6, 2018</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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers)</measure>
    <time_frame>up to week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-intervention health related quality of life (measured by questionnaire)</measure>
    <time_frame>up to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2)</measure>
    <time_frame>up to week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Physical Activity</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Fitbit + Facebook + Health Coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will use the Fitbit device and join the Facebook group. They will also receive brief weekly health coaching from a research staff. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide them with support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care control with Fitbit only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be loaned a Fitbit device only. They will not join the Facebook group nor receive health coaching. They will not select an adult family member or friend to receive a Fitbit device to provide them with support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fitbit + Facebook + Coaching Group</intervention_name>
    <description>Participants will use the FitBit device to track their physical activity (PA). Participants will receive and post messages and receive badges on the Facebook group. Weekly a research staff member will call them to provide brief health coaching. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide support.</description>
    <arm_group_label>Fitbit + Facebook + Health Coaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fitbit only</intervention_name>
    <description>Participants will receive a Fitbit device only, and will not receive health coaching, join the Facebook group, or select an adult family member or friend to receive a Fitbit to provide them with support.</description>
    <arm_group_label>Usual care control with Fitbit only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Does not meet recommended guidelines for physical activity (PA,150 min of moderate&#xD;
             activity or 75 min of vigorous activity)&#xD;
&#xD;
          -  Currently between 1.0-5.0 years from the completion of active cancer therapy&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Have a smart phone (or can borrow a study-provided iPod Touch) and willing to use it&#xD;
             for the mobile app and Facebook group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or planning on becoming pregnant in the next year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98145-5005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>May 23, 2018</last_update_submitted>
  <last_update_submitted_qc>May 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Jason Mendoza</investigator_full_name>
    <investigator_title>Investigator and Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <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/NCT03233581
org study id: Fitbit YA 9865
nct id: NCT03233581
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the
      Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the
      Fitbit mobile health (mHealth) app. The target population will be cancer survivors 18-39
      years old recruited from the Seattle Cancer Care Alliance. For the intervention group, peer
      influences will be engaged via a private, social network (e.g. a Facebook group) customized
      for survivors. Measurements will be completed (1) at baseline, prior to randomization, and
      (2) during the final week of the intervention period (follow-up measure). This pilot study
      will provide initial proof of concept and allow for further customization of the intervention
      for cancer survivors in anticipation of a future, larger proposal to study physical activity
      and related outcomes over a multi-year period.

      Besides conducting exploratory analyses of primary and secondary outcomes for this pilot RCT,
      we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39
      years and between 1.0-5.0 years from the completion of active cancer therapy, (2)
      intervention participants wear the Fitbit Flex on the majority of all intervention days
      during the 12-week intervention period, and (3) ≥75% of all participants complete online
      questionnaire data collection at Time 1 and Time 2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers)
time frame: up to week 12
measure: Post-intervention health related quality of life (measured by questionnaire)
time frame: up to week 12
measure: Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2)
time frame: up to week 12
arm group label: Fitbit + Facebook + Health Coaching
arm group type: Experimental
description: Participants will use the Fitbit device and join the Facebook group. They will also receive brief weekly health coaching from a research staff. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide them with support.
arm group label: Usual care control with Fitbit only
arm group type: Active Comparator
description: Participants will be loaned a Fitbit device only. They will not join the Facebook group nor receive health coaching. They will not select an adult family member or friend to receive a Fitbit device to provide them with support.
intervention type: Behavioral
intervention name: Fitbit + Facebook + Coaching Group
description: Participants will use the FitBit device to track their physical activity (PA). Participants will receive and post messages and receive badges on the Facebook group. Weekly a research staff member will call them to provide brief health coaching. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide support.
arm group label: Fitbit + Facebook + Health Coaching
intervention type: Behavioral
intervention name: Fitbit only
description: Participants will receive a Fitbit device only, and will not receive health coaching, join the Facebook group, or select an adult family member or friend to receive a Fitbit to provide them with support.
arm group label: Usual care control with Fitbit only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Jason Mendoza
investigator title: Investigator and Associate Professor of Pediatrics
sharing ipd: No