<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/NCT02255240</url>
  </required_header>
  <id_info>
    <org_study_id>14-0240</org_study_id>
    <secondary_id>1K07CA175141-01A1</secondary_id>
    <nct_id>NCT02255240</nct_id>
  </id_info>
  <brief_title>LEVEL UP: Video Games for Activity in Breast Cancer Survivors</brief_title>
  <acronym>LEVEL UP</acronym>
  <official_title>LEVEL UP: Leveraging Electronic Videogames for Exercise and Leisure: Understanding Preferences of Breast Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test an intervention that uses home console video games to&#xD;
      encourage increased physical activity among postmenopausal breast cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research project includes qualitative and quantitative formative research leading to a&#xD;
      randomized controlled feasibility trial of a video game-based physical activity intervention.&#xD;
      First, we will investigate exercise protocols implemented over 6 weeks in 20 breast cancer&#xD;
      survivors. We will choose a console and six games for inclusion in the trial, based on&#xD;
      measured energy expenditure and enjoyment. We will create refined exercise protocols using&#xD;
      these games and insights from participants. Second, we will test an intervention that uses&#xD;
      active video games for implementation of motivating exercise and provision of behavioral&#xD;
      tools (e.g., tracking of progress towards goals). Participants in a pre-pilot trial (N = 10)&#xD;
      will receive weekly brief telephone counseling over 6 weeks. Feasibility measurement will&#xD;
      include attrition, self-reported acceptability, and objective measures of video game play&#xD;
      taken from game console data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Relinquished grant funding due to receipt of another incompatible grant&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in physical activity from baseline to 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Minutes of moderate-vigorous physical activity measured over a 7 day period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in physical fitness from baseline to 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>We will use a six minute walk test to measure fitness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight from baseline to 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Weight will be measured using a calibrated scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in motivation from baseline to 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>We will measure autonomous motivation (intrinsic, integrated, identified, etc.) specific to physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body function from baseline to 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>We will use the Senior Fitness Test to measure strength and body function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life from baseline to 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>We will use the Functional Assessment of Cancer Therapy - Breast measure to quantify quality of life</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants who drop out of the study from baseline to 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>We will investigate the number of participants who drop out of the intervention group in comparison to similar studies</description>
  </other_outcome>
  <other_outcome>
    <measure>Acceptability</measure>
    <time_frame>6 weeks</time_frame>
    <description>We will measure acceptability of the intervention components and tools using validated self-report measures and qualitative interviews/focus groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants who report adverse events</measure>
    <time_frame>6 weeks</time_frame>
    <description>We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence</measure>
    <time_frame>6 weeks</time_frame>
    <description>We will use objective measures to investigate adherence to game play protocols (console logs, automatic postings to the console social network, etc.)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Physical activity intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive the physical activity intervention, which consists of three individual meetings, weekly brief counseling phone calls for 6 weeks, and provision of a video game console with three active video games.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity intervention</intervention_name>
    <description>Participants will receive counseling on self-regulatory skill building that has been adapted to complement the video games used. We anticipate that the games used will consist of fitness, sports, and dance games and will be played on a Wii U console. The games played will be chosen by each participant from a pool of potential appropriate games.</description>
    <arm_group_label>Physical activity intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Aged 45 - 75&#xD;
&#xD;
          -  Diagnosed with breast cancer within the past 10 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chemotherapy or radiation treatment in the past six months&#xD;
&#xD;
          -  Surgery in the past six months&#xD;
&#xD;
          -  Evidence of disease recurrence&#xD;
&#xD;
          -  Unable to read and understand English&#xD;
&#xD;
          -  Unable to see a TV screen from several feet away&#xD;
&#xD;
          -  Unable to find transportation to the study location&#xD;
&#xD;
          -  No Internet access in the home (only for intervention portion of the study)&#xD;
&#xD;
          -  Participant is active (60 minutes of moderate-vigorous intensity activity per week or&#xD;
             more)&#xD;
&#xD;
          -  BMI is under 18.5 kg/m2 or over 40 kg/m2&#xD;
&#xD;
          -  Participant reports psychological issues that would interfere with study completion.&#xD;
             Examples will be provided to illustrate potential psychological issues, such as&#xD;
             dementia or schizophrenia.&#xD;
&#xD;
          -  Inadequate performance on Senior Fitness Test, indicating inability to engage in video&#xD;
             game exercise procedures (total score &lt; 9 out of 12)&#xD;
&#xD;
          -  Report a heart condition, chest pain during periods of activity or rest, loss of&#xD;
             consciousness, etc. on the Physical Activity Readiness Questionnaire (PAR-Q), unless&#xD;
             cleared by their physician&#xD;
&#xD;
          -  Unable to walk, jump, and jog as may be required by some games (self-report)&#xD;
&#xD;
          -  Report current symptoms of alcohol or substance dependence&#xD;
&#xD;
          -  Plans to move away from the Galveston-Houston area or to be out of town for more than&#xD;
             1 week during the study period&#xD;
&#xD;
          -  Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes&#xD;
&#xD;
          -  Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months&#xD;
&#xD;
          -  Report a history of orthopedic complications that would prevent optimal participation&#xD;
             in the physical activities prescribed (e.g., heel spurs, severe arthritis)&#xD;
&#xD;
          -  Clinical judgment concerning safety&#xD;
&#xD;
          -  Currently participating in a physical activity or weight program/research study&#xD;
&#xD;
          -  Currently pregnant or nursing&#xD;
&#xD;
          -  No TV is available in the participant's home&#xD;
&#xD;
          -  Currently on a weight loss diet or has lost more than 5% body weight in the previous 6&#xD;
             months&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Game console to be used in the study is already available in the home&#xD;
&#xD;
          -  Another member of the household is a participant or staff member on this trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth J Lyons, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>May 26, 2015</last_update_submitted>
  <last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>cancer</keyword>
  <keyword>survivorship</keyword>
  <keyword>cancer survivor</keyword>
  <keyword>physical activity</keyword>
  <keyword>video game</keyword>
  <keyword>women</keyword>
  <keyword>women's health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT02255240
org study id: 14-0240
secondary id: 1K07CA175141-01A1
nct id: NCT02255240
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to test an intervention that uses home console video games to
      encourage increased physical activity among postmenopausal breast cancer survivors.
This research project includes qualitative and quantitative formative research leading to a
      randomized controlled feasibility trial of a video game-based physical activity intervention.
      First, we will investigate exercise protocols implemented over 6 weeks in 20 breast cancer
      survivors. We will choose a console and six games for inclusion in the trial, based on
      measured energy expenditure and enjoyment. We will create refined exercise protocols using
      these games and insights from participants. Second, we will test an intervention that uses
      active video games for implementation of motivating exercise and provision of behavioral
      tools (e.g., tracking of progress towards goals). Participants in a pre-pilot trial (N = 10)
      will receive weekly brief telephone counseling over 6 weeks. Feasibility measurement will
      include attrition, self-reported acceptability, and objective measures of video game play
      taken from game console data.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change in physical activity from baseline to 6 weeks
time frame: 6 weeks
description: Minutes of moderate-vigorous physical activity measured over a 7 day period
measure: Change in physical fitness from baseline to 6 weeks
time frame: 6 weeks
description: We will use a six minute walk test to measure fitness
measure: Change in weight from baseline to 6 weeks
time frame: 6 weeks
description: Weight will be measured using a calibrated scale
measure: Change in motivation from baseline to 6 weeks
time frame: 6 weeks
description: We will measure autonomous motivation (intrinsic, integrated, identified, etc.) specific to physical activity
measure: Change in body function from baseline to 6 weeks
time frame: 6 weeks
description: We will use the Senior Fitness Test to measure strength and body function
measure: Change in quality of life from baseline to 6 weeks
time frame: 6 weeks
description: We will use the Functional Assessment of Cancer Therapy - Breast measure to quantify quality of life
measure: Number of participants who drop out of the study from baseline to 6 weeks
time frame: 6 weeks
description: We will investigate the number of participants who drop out of the intervention group in comparison to similar studies
measure: Acceptability
time frame: 6 weeks
description: We will measure acceptability of the intervention components and tools using validated self-report measures and qualitative interviews/focus groups
measure: Number of participants who report adverse events
time frame: 6 weeks
description: We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed.
measure: Adherence
time frame: 6 weeks
description: We will use objective measures to investigate adherence to game play protocols (console logs, automatic postings to the console social network, etc.)
arm group label: Physical activity intervention
arm group type: Experimental
description: This arm will receive the physical activity intervention, which consists of three individual meetings, weekly brief counseling phone calls for 6 weeks, and provision of a video game console with three active video games.
intervention type: Behavioral
intervention name: Physical activity intervention
description: Participants will receive counseling on self-regulatory skill building that has been adapted to complement the video games used. We anticipate that the games used will consist of fitness, sports, and dance games and will be played on a Wii U console. The games played will be chosen by each participant from a pool of potential appropriate games.
arm group label: Physical activity intervention
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth J Lyons, PhD, MPH
role: Principal Investigator
affiliation: University of Texas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms