xml: <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/NCT06012825</url>
    </required_header>
    <id_info>
      <org_study_id>2021-084</org_study_id>
      <nct_id>NCT06012825</nct_id>
    </id_info>
    <brief_title>Pediatric Physical Activity for Children With Cancer</brief_title>
    <acronym>PePA</acronym>
    <official_title>Pediatric Physical Activity (PePA): Understanding Best Practices in Implementing Physical Activity for Patients Diagnosed With Childhood Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Hawaii</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hawaii Pacific Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Hawaii Cancer Research Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Hawaii</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 pilot study is to test the feasibility and participant adherence (pediatric&#xD;
        patients diagnosed with childhood cancer) to a virtual, 12-week physical activity program.&#xD;
  &#xD;
        The aims of this project are to:&#xD;
  &#xD;
          1. Determine the feasibility of administering the program and patient acceptability.&#xD;
  &#xD;
          2. Report program adherence and completion rates.&#xD;
  &#xD;
          3. Explore trends on the impact of a virtual PA intervention on psychosocial health and&#xD;
             physical fitness.&#xD;
  &#xD;
        Participants will undergo pre- and post-assessments including measurements of fitness,&#xD;
        self-reported fatigue and depression symptoms, social support, and current amount of physical&#xD;
        activity. Patients will then be invited to participate in two consecutive, 12-week virtual&#xD;
        physical activity interventions with similar-aged peers (2x/week, 60 minutes/session) over 2&#xD;
        rounds.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It is critical for childhood cancer patients to maintain a physical activity (PA) regime as&#xD;
        they are at an increased risk of developing co-morbidities. PA engagement is associated with&#xD;
        positive psychosocial outcomes, and it has the potential to improve cardiopulmonary and&#xD;
        musculoskeletal function. Patients will be enrolled and will undergo baseline assessments of&#xD;
        fitness and quality of life as part of their standard care, and additional measures that&#xD;
        include fatigue, depression, social support, and PA volume will be measured. Patients will be&#xD;
        invited to participate in a 12-week virtual PA intervention with similar-aged peers (2x/week,&#xD;
        60 minutes/session). Patients will be led through activities that are culturally relevant and&#xD;
        age-appropriate. At the end of the 12-week intervention, the same tests will be completed.&#xD;
        The patients will have an opportunity to receive 2 interventions. A mixed method design will&#xD;
        be used, where quantitative data will include information related to feasibility, PA volume,&#xD;
        physical fitness, and psychosocial health measures, and qualitative data will be collected&#xD;
        from the patients during the focus groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Actual">May 12, 2023</completion_date>
    <primary_completion_date type="Actual">May 9, 2023</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>Enrollment</measure>
      <time_frame>Tracked at the time of enrollment</time_frame>
      <description>The number of enrolled patients</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration in minutes</measure>
      <time_frame>Duration (minutes) will be measured each session up to 12 weeks.</time_frame>
      <description>The investigators will determine if the delivery of a virtual physical activity program is feasible by tracking the number of minutes spent in the warm up, activity and cool-down.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart Rate</measure>
      <time_frame>Intensity ( heart rate) will be measured each session up to 12 weeks.</time_frame>
      <description>In order to objectively measure the intensity level and volume of PA during the activity sessions, participants will wear accelerometers on their waist and a wrist-based heart rate will be used to intensity of PA in real-time.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Relative Rate of Perceived Exertion</measure>
      <time_frame>Intensity (RPE) will be measured each session up to 12 weeks.</time_frame>
      <description>Rate of perceived exertion (RPE) will be obtained from participants as a subjective measure of intensity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the program by patients</measure>
      <time_frame>Focus groups will be conducted up to 12 weeks.</time_frame>
      <description>The virtual activities also need to enjoyable, so with the use of focus groups, patient acceptability of the program will be determined. Predetermined questions and prompts will be used, such as, &quot;Describe a lesson or lessons you liked best. What are some lessons that were less enjoyable? What was the most difficult aspect of participating in PePA? In general, did the exercises feel like they provided the right amount of exertion, too intense, not intense enough? Was the duration of each session too long, too short or about right?&quot;. The focus group recording will be transcribed and themes will be identified in this qualitative analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence</measure>
      <time_frame>Attendance will be measured each week up to 12 weeks. If the participant continues for a second round, adherence will be measured each week during the second intervention up to 12 weeks.</time_frame>
      <description>The number of completing patients. This will be measured by counting the number of participants who completed the majority of the program for each round (i.e., 20 out of 24 sessions).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life (QL)</measure>
      <time_frame>Change from baseline QL at 12 weeks.</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program with the following measure:&#xD;
  Quality of life with the Pediatric Quality of Life Inventory General Well-Being Scale (PedsQL Inventory, 23 items). Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores reflect better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Intention</measure>
      <time_frame>Change from baseline physical activity intention at 12 weeks.</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program on the following measure:&#xD;
  Physical Activity (PA) intention with the PA Intention Inventory (6 items). The first 3 items ask about the number of days over the past week the participant engaged in PA for 60 minutes, the number of days PA was engaged which resulted in elevated heart rate, and the number of days that the participant engaged in resistance exercises. Responses range from 0-7 days with greater days indicating more activity.&#xD;
  The last 3 questions ask the participant about his/her intention to engage in PA outside of school, participate in PA which makes him/her breathe hard in the next 2 weeks and if s/he expects to exercise outside of school that makes him/her breathe hard in the next 2 weeks. Answers correspond to 0=strongly agree, 1=agree, 2= not sure, 3=disagree, 4=strongly disagree. Scores range from 0-12, with lower scores reflecting better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social Support</measure>
      <time_frame>Change from baseline Social Support at 12 weeks.</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program on the following measure:&#xD;
  Social support toward PA from friends and parents (Social Support Questionnaire, 8 items). Items are answered with very often (0), often (1), neutral (2), sometimes (3) or never (4). Scores range from 0 to 32. Lower scores represent better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>Change from baseline Fatigue at 12 weeks.</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program on the following measure:&#xD;
  Fatigue using the PedsQL Multidimensional Fatigue Scale Questionnaire (18 items). Items are transformed to a 0-100 scale, where 0=100, 1=75, 3=25, 4=0. Scores are averaged (divided by 18) and range from 0-100. Higher scores indicate fewer problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>Change from baseline Depression at 12 weeks.</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program on the following measure:&#xD;
  Depression using the Children's Depression Inventory (12 items). Items 1, 3-6, 8, 10-12 correspond to emotional problems. Items 2, 7, 9, 13-17 correspond to function problems. Reverse scoring is used for items 2, 7, 13, 14, 16. Higher scores indicate greater problems. Scores are compared to normative ranges (0-39+), which are age- and sex-dependent.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiorespiratory endurance</measure>
      <time_frame>Change from baseline Cardiorespiratory Endurance at 12 weeks.</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program on the following measure:&#xD;
  Cardiorespiratory endurance using the 6-minute walk test (ml/kg/min).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Flexibility</measure>
      <time_frame>Change from baseline Flexibility at 12 weeks.</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program on the following measure:&#xD;
  Range of motion using goniometry (degrees).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hand Strength</measure>
      <time_frame>Change from baseline Hand Strength at 12 weeks.</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program on the following measure:&#xD;
  Hand strength will be measured with hand-held dynamometry (kg).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscular Strength</measure>
      <time_frame>Change from baseline Muscular Strength at 12 weeks.</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program on the following measure:&#xD;
  A manual muscle testing (scale that rates trace, poor, fair, good, normal performance) will be used to measure Muscular Strength.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Balance</measure>
      <time_frame>Change from baseline Balance at 12 weeks.</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program on the following measure:&#xD;
  Balance using the Berg Balance Scale (14 items). Scores range from 0 to 56 with higher scores reflecting better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Activity of daily living (ADL)</measure>
      <time_frame>Change from baseline ADL at 12 weeks..</time_frame>
      <description>The investigators will explore the trends of a virtual physical activity program on the following measure:&#xD;
  Assessment of the ability to perform activities of daily living (ADL, QuickDASH Inventory, 11 items). Items are scored as no difficulty (1), mild difficulty (2), moderate difficulty (3), severe difficult (4), to unable to achieve (5). At least 10 items need to be completed and is measured on a scale of 0-100 with a higher score indicating greater disability.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">12</enrollment>
    <condition>Pediatric Cancer</condition>
    <condition>Physical Activity</condition>
    <arm_group>
      <arm_group_label>Physical Activity (PA) Round 1</arm_group_label>
      <description>All enrollees will have the opportunity to attend virtual PA sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Physical Activity Round 2</arm_group_label>
      <description>This second cohort is the 2nd round of intervention, which allows participants to enroll for another round, and/or newly recruited patients will have the opportunity to participate.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Physical Activity</intervention_name>
      <description>The program will consist of 2 consecutive rounds of 12-week programming, 2x/week for 60 minutes on a Health Insurance Portability and Accountability Act (HIPAA)-compliant Zoom account. The PA program will be structured to ensure equivalent &quot;PA doses&quot; are provided. This will be done by allocating time to a warm-up (5 min), an introduction and demonstration of the activity (5 min), the PA (30 min), cool down and stretching (5 min). Time will also be devoted for interaction to develop rapport, transition to the next activity, and to handle internet connectivity issues (15 min).</description>
      <arm_group_label>Physical Activity (PA) Round 1</arm_group_label>
      <arm_group_label>Physical Activity Round 2</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients referred by their physician at a primary care facility.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having been diagnosed with cancer&#xD;
  &#xD;
            -  Ability to connect to virtual sessions 2x/week&#xD;
  &#xD;
            -  English literacy&#xD;
  &#xD;
            -  Having guardian consent and patient assent.&#xD;
  &#xD;
            -  Eligible patients will be those who do not require physical therapy (i.e., able to&#xD;
               dress, ambulate) and will be physically able to participate, as determined by therapy&#xD;
               staff.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not having been diagnosed with cancer.&#xD;
  &#xD;
            -  Inability to communicate in English&#xD;
  &#xD;
            -  Requires physical or occupational therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Paulette Yamada Tamashiro, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Hawaii</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Hawaii Cancer Center</name>
        <address>
          <city>Honolulu</city>
          <state>Hawaii</state>
          <zip>96813</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Hawaii at Manoa</name>
        <address>
          <city>Honolulu</city>
          <state>Hawaii</state>
          <zip>96822</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Kapi'olani Medical Center for Women and Children</name>
        <address>
          <city>Honolulu</city>
          <state>Hawaii</state>
          <zip>96826</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Ouyang N, Cai R, Zhou X, Huang H, Qiu X, Liu K. Effects of a group-based physical activity program for pediatric patients with cancer on physical activity and symptom experience: A quasi-experimental study. Pediatr Blood Cancer. 2019 Nov;66(11):e27965. doi: 10.1002/pbc.27965. Epub 2019 Aug 12.</citation>
      <PMID>31407493</PMID>
    </reference>
    <reference>
      <citation>Honas JJ, Washburn RA, Smith BK, Greene JL, Cook-Wiens G, Donnelly JE. The System for Observing Fitness Instruction Time (SOFIT) as a measure of energy expenditure during classroom-based physical activity. Pediatr Exerc Sci. 2008 Nov;20(4):439-45. doi: 10.1123/pes.20.4.439.</citation>
      <PMID>19168920</PMID>
    </reference>
    <reference>
      <citation>Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.</citation>
      <PMID>11932914</PMID>
    </reference>
    <reference>
      <citation>Panepinto JA, Torres S, Bendo CB, McCavit TL, Dinu B, Sherman-Bien S, Bemrich-Stolz C, Varni JW. PedsQL Multidimensional Fatigue Scale in sickle cell disease: feasibility, reliability, and validity. Pediatr Blood Cancer. 2014 Jan;61(1):171-7. doi: 10.1002/pbc.24776. Epub 2013 Sep 13.</citation>
      <PMID>24038960</PMID>
    </reference>
    <reference>
      <citation>Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.</citation>
      <PMID>17057441</PMID>
    </reference>
    <reference>
      <citation>Quatman-Yates CC, Gupta R, Paterno MV, Schmitt LC, Quatman CE, Ittenbach RF. Internal consistency and validity of the QuickDASH instrument for upper extremity injuries in older children. J Pediatr Orthop. 2013 Dec;33(8):838-42. doi: 10.1097/BPO.0b013e3182a00688.</citation>
      <PMID>23863415</PMID>
    </reference>
    <reference>
      <citation>Rider BC, Conger SA, Ditzenberger GL, Besteman SS, Bouret CM, Coughlin AM. Examining the Accuracy of the Polar A360 Monitor. J Strength Cond Res. 2021 Aug 1;35(8):2165-2169. doi: 10.1519/JSC.0000000000003136.</citation>
      <PMID>34398076</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Hawaii</investigator_affiliation>
      <investigator_full_name>Paulette M. Yamada</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Since the number of subjects that will is small (n=12), IPD may be easily tracked to the patient themselves. If it is possible to mask / de-identify data, IPD may be shared at the conclusion of this study.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012825
  org study id: 2021-084
  nct id: NCT06012825
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this pilot study is to test the feasibility and participant adherence (pediatric
        patients diagnosed with childhood cancer) to a virtual, 12-week physical activity program.
  
        The aims of this project are to:
  
          1. Determine the feasibility of administering the program and patient acceptability.
  
          2. Report program adherence and completion rates.
  
          3. Explore trends on the impact of a virtual PA intervention on psychosocial health and
             physical fitness.
  
        Participants will undergo pre- and post-assessments including measurements of fitness,
        self-reported fatigue and depression symptoms, social support, and current amount of physical
        activity. Patients will then be invited to participate in two consecutive, 12-week virtual
        physical activity interventions with similar-aged peers (2x/week, 60 minutes/session) over 2
        rounds.
  It is critical for childhood cancer patients to maintain a physical activity (PA) regime as
        they are at an increased risk of developing co-morbidities. PA engagement is associated with
        positive psychosocial outcomes, and it has the potential to improve cardiopulmonary and
        musculoskeletal function. Patients will be enrolled and will undergo baseline assessments of
        fitness and quality of life as part of their standard care, and additional measures that
        include fatigue, depression, social support, and PA volume will be measured. Patients will be
        invited to participate in a 12-week virtual PA intervention with similar-aged peers (2x/week,
        60 minutes/session). Patients will be led through activities that are culturally relevant and
        age-appropriate. At the end of the 12-week intervention, the same tests will be completed.
        The patients will have an opportunity to receive 2 interventions. A mixed method design will
        be used, where quantitative data will include information related to feasibility, PA volume,
        physical fitness, and psychosocial health measures, and qualitative data will be collected
        from the patients during the focus groups.
  observational model: Cohort
  time perspective: Prospective
  measure: Enrollment
  time frame: Tracked at the time of enrollment
  description: The number of enrolled patients
  measure: Duration in minutes
  time frame: Duration (minutes) will be measured each session up to 12 weeks.
  description: The investigators will determine if the delivery of a virtual physical activity program is feasible by tracking the number of minutes spent in the warm up, activity and cool-down.
  measure: Heart Rate
  time frame: Intensity ( heart rate) will be measured each session up to 12 weeks.
  description: In order to objectively measure the intensity level and volume of PA during the activity sessions, participants will wear accelerometers on their waist and a wrist-based heart rate will be used to intensity of PA in real-time.
  measure: Relative Rate of Perceived Exertion
  time frame: Intensity (RPE) will be measured each session up to 12 weeks.
  description: Rate of perceived exertion (RPE) will be obtained from participants as a subjective measure of intensity.
  measure: Acceptability of the program by patients
  time frame: Focus groups will be conducted up to 12 weeks.
  description: The virtual activities also need to enjoyable, so with the use of focus groups, patient acceptability of the program will be determined. Predetermined questions and prompts will be used, such as, "Describe a lesson or lessons you liked best. What are some lessons that were less enjoyable? What was the most difficult aspect of participating in PePA? In general, did the exercises feel like they provided the right amount of exertion, too intense, not intense enough? Was the duration of each session too long, too short or about right?". The focus group recording will be transcribed and themes will be identified in this qualitative analysis.
  measure: Adherence
  time frame: Attendance will be measured each week up to 12 weeks. If the participant continues for a second round, adherence will be measured each week during the second intervention up to 12 weeks.
  description: The number of completing patients. This will be measured by counting the number of participants who completed the majority of the program for each round (i.e., 20 out of 24 sessions).
  measure: Health-related quality of life (QL)
  time frame: Change from baseline QL at 12 weeks.
  description: The investigators will explore the trends of a virtual physical activity program with the following measure:
  Quality of life with the Pediatric Quality of Life Inventory General Well-Being Scale (PedsQL Inventory, 23 items). Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores reflect better outcomes.
  measure: Physical Activity Intention
  time frame: Change from baseline physical activity intention at 12 weeks.
  description: The investigators will explore the trends of a virtual physical activity program on the following measure:
  Physical Activity (PA) intention with the PA Intention Inventory (6 items). The first 3 items ask about the number of days over the past week the participant engaged in PA for 60 minutes, the number of days PA was engaged which resulted in elevated heart rate, and the number of days that the participant engaged in resistance exercises. Responses range from 0-7 days with greater days indicating more activity.
  The last 3 questions ask the participant about his/her intention to engage in PA outside of school, participate in PA which makes him/her breathe hard in the next 2 weeks and if s/he expects to exercise outside of school that makes him/her breathe hard in the next 2 weeks. Answers correspond to 0=strongly agree, 1=agree, 2= not sure, 3=disagree, 4=strongly disagree. Scores range from 0-12, with lower scores reflecting better outcomes.
  measure: Social Support
  time frame: Change from baseline Social Support at 12 weeks.
  description: The investigators will explore the trends of a virtual physical activity program on the following measure:
  Social support toward PA from friends and parents (Social Support Questionnaire, 8 items). Items are answered with very often (0), often (1), neutral (2), sometimes (3) or never (4). Scores range from 0 to 32. Lower scores represent better outcomes.
  measure: Fatigue
  time frame: Change from baseline Fatigue at 12 weeks.
  description: The investigators will explore the trends of a virtual physical activity program on the following measure:
  Fatigue using the PedsQL Multidimensional Fatigue Scale Questionnaire (18 items). Items are transformed to a 0-100 scale, where 0=100, 1=75, 3=25, 4=0. Scores are averaged (divided by 18) and range from 0-100. Higher scores indicate fewer problems.
  measure: Depression
  time frame: Change from baseline Depression at 12 weeks.
  description: The investigators will explore the trends of a virtual physical activity program on the following measure:
  Depression using the Children's Depression Inventory (12 items). Items 1, 3-6, 8, 10-12 correspond to emotional problems. Items 2, 7, 9, 13-17 correspond to function problems. Reverse scoring is used for items 2, 7, 13, 14, 16. Higher scores indicate greater problems. Scores are compared to normative ranges (0-39+), which are age- and sex-dependent.
  measure: Cardiorespiratory endurance
  time frame: Change from baseline Cardiorespiratory Endurance at 12 weeks.
  description: The investigators will explore the trends of a virtual physical activity program on the following measure:
  Cardiorespiratory endurance using the 6-minute walk test (ml/kg/min).
  measure: Flexibility
  time frame: Change from baseline Flexibility at 12 weeks.
  description: The investigators will explore the trends of a virtual physical activity program on the following measure:
  Range of motion using goniometry (degrees).
  measure: Hand Strength
  time frame: Change from baseline Hand Strength at 12 weeks.
  description: The investigators will explore the trends of a virtual physical activity program on the following measure:
  Hand strength will be measured with hand-held dynamometry (kg).
  measure: Muscular Strength
  time frame: Change from baseline Muscular Strength at 12 weeks.
  description: The investigators will explore the trends of a virtual physical activity program on the following measure:
  A manual muscle testing (scale that rates trace, poor, fair, good, normal performance) will be used to measure Muscular Strength.
  measure: Balance
  time frame: Change from baseline Balance at 12 weeks.
  description: The investigators will explore the trends of a virtual physical activity program on the following measure:
  Balance using the Berg Balance Scale (14 items). Scores range from 0 to 56 with higher scores reflecting better outcomes.
  measure: Activity of daily living (ADL)
  time frame: Change from baseline ADL at 12 weeks..
  description: The investigators will explore the trends of a virtual physical activity program on the following measure:
  Assessment of the ability to perform activities of daily living (ADL, QuickDASH Inventory, 11 items). Items are scored as no difficulty (1), mild difficulty (2), moderate difficulty (3), severe difficult (4), to unable to achieve (5). At least 10 items need to be completed and is measured on a scale of 0-100 with a higher score indicating greater disability.
  arm group label: Physical Activity (PA) Round 1
  description: All enrollees will have the opportunity to attend virtual PA sessions.
  arm group label: Physical Activity Round 2
  description: This second cohort is the 2nd round of intervention, which allows participants to enroll for another round, and/or newly recruited patients will have the opportunity to participate.
  intervention type: Behavioral
  intervention name: Physical Activity
  description: The program will consist of 2 consecutive rounds of 12-week programming, 2x/week for 60 minutes on a Health Insurance Portability and Accountability Act (HIPAA)-compliant Zoom account. The PA program will be structured to ensure equivalent "PA doses" are provided. This will be done by allocating time to a warm-up (5 min), an introduction and demonstration of the activity (5 min), the PA (30 min), cool down and stretching (5 min). Time will also be devoted for interaction to develop rapport, transition to the next activity, and to handle internet connectivity issues (15 min).
  arm group label: Physical Activity (PA) Round 1
  arm group label: Physical Activity Round 2
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Paulette Yamada Tamashiro, PhD
  role: Principal Investigator
  affiliation: University of Hawaii
  facility: 
  facility: 
  facility: 
  country: United States
  citation: Ouyang N, Cai R, Zhou X, Huang H, Qiu X, Liu K. Effects of a group-based physical activity program for pediatric patients with cancer on physical activity and symptom experience: A quasi-experimental study. Pediatr Blood Cancer. 2019 Nov;66(11):e27965. doi: 10.1002/pbc.27965. Epub 2019 Aug 12.
  PMID: 31407493
  citation: Honas JJ, Washburn RA, Smith BK, Greene JL, Cook-Wiens G, Donnelly JE. The System for Observing Fitness Instruction Time (SOFIT) as a measure of energy expenditure during classroom-based physical activity. Pediatr Exerc Sci. 2008 Nov;20(4):439-45. doi: 10.1123/pes.20.4.439.
  PMID: 19168920
  citation: Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
  PMID: 11932914
  citation: Panepinto JA, Torres S, Bendo CB, McCavit TL, Dinu B, Sherman-Bien S, Bemrich-Stolz C, Varni JW. PedsQL Multidimensional Fatigue Scale in sickle cell disease: feasibility, reliability, and validity. Pediatr Blood Cancer. 2014 Jan;61(1):171-7. doi: 10.1002/pbc.24776. Epub 2013 Sep 13.
  PMID: 24038960
  citation: Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
  PMID: 17057441
  citation: Quatman-Yates CC, Gupta R, Paterno MV, Schmitt LC, Quatman CE, Ittenbach RF. Internal consistency and validity of the QuickDASH instrument for upper extremity injuries in older children. J Pediatr Orthop. 2013 Dec;33(8):838-42. doi: 10.1097/BPO.0b013e3182a00688.
  PMID: 23863415
  citation: Rider BC, Conger SA, Ditzenberger GL, Besteman SS, Bouret CM, Coughlin AM. Examining the Accuracy of the Polar A360 Monitor. J Strength Cond Res. 2021 Aug 1;35(8):2165-2169. doi: 10.1519/JSC.0000000000003136.
  PMID: 34398076
  responsible party type: Principal Investigator
  investigator affiliation: University of Hawaii
  investigator full name: Paulette M. Yamada
  investigator title: Associate Professor
  sharing ipd: Undecided
  ipd description: Since the number of subjects that will is small (n=12), IPD may be easily tracked to the patient themselves. If it is possible to mask / de-identify data, IPD may be shared at the conclusion of this study.