<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/NCT03016728</url>
  </required_header>
  <id_info>
    <org_study_id>Ottawa</org_study_id>
    <nct_id>NCT03016728</nct_id>
  </id_info>
  <brief_title>Physical Activity for Adolescent and Young Adult Cancer Survivors</brief_title>
  <official_title>Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Ottawa</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>
      More adolescents and young adults are surviving cancer than ever before. Many endure negative&#xD;
      effects related to their cancer and its treatment, which reduces their quality of life and&#xD;
      functioning. Physical activity is one strategy that has been shown to promote quality of life&#xD;
      amongst cancer survivors. However, very little research has focused on adolescent and young&#xD;
      adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is&#xD;
      to explore the feasibility, safety, and potential benefits of a 12-week home-based physical&#xD;
      activity intervention in adolescent and young adult cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">May 5, 2019</completion_date>
  <primary_completion_date type="Actual">April 16, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment Rates</measure>
    <time_frame>Through study completion, an average of 12-24 weeks</time_frame>
    <description>The number of eligible participants who enrol in the study out of the number who are referred.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention Rates</measure>
    <time_frame>Through study completion, an average of 12-24 weeks</time_frame>
    <description>The number of participants completing the intervention and all scheduled assessments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence Rates</measure>
    <time_frame>Through study completion, an average of 12-24 weeks</time_frame>
    <description>The number of physical activity sessions engaged in out of the total recommended as part of the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Through study completion, an average of 12-24 weeks</time_frame>
    <description>The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the physical activity intervention and/or its assessments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Behaviour: Daily Physical Activity Logbook</measure>
    <time_frame>Through study completion, an average of 12-24 weeks</time_frame>
    <description>Change in daily self-reported daily physical activity from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin &amp; Shephard, 1985)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)</time_frame>
    <description>Change in self-reported physical activity (over the past 7 days) from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Behaviour: 7-Day Accelerometer Wear (Objective Physical Activity Behaviour)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)</time_frame>
    <description>Change in objective levels of physical activity as measured by accelerometers (Actigraph wGT3XP-BT), which will be worn for a 7 day period from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting Heart Rate</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in resting heart rate, as measured by a heart rate monitor (Polar A300), from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in resting blood pressure, using a blood pressure monitor (HealthSmart Digital Blood Pressure Monitor), from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition: Body Mass Index</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in body mass as determined by a Tanita scale (TBF-310 GS) that uses bioelectrical impedance to assess body composition from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aerobic Capacity: 6-Minute Walk Test (CSEP, 2013; Irwin, 2012)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Musculoskeletal Strength: Combined Grip Strength using a Handheld Dynamometer (CSEP, 2013; Irwin, 2012)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular Endurance: 30-Second Sit to Stand Test (Rikli &amp; Jones, 2001)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in muscular endurance (i.e., number of times participants can stand from a seated position in 30 seconds) from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy: Single-Item Version of the Exercise Self-Efficacy Scale (McAuley, 1993)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in participants self-reported self-efficacy from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Competence and Physical Self-Esteem: Physical Self-Description Questionnaire Short-Form Appearance, Strength, Endurance, Body Fat, and Physical Self-Esteem scales (Marsh, Martin, &amp; Jackson, 2010)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in participants self-reported physical competence and physical self-esteem from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Self-Esteem: Rosenberg Global Self-Esteem Scale (Rosenberg, 1965)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in participants self-reported global self-esteem from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Image: Multidimensional Body-Self Relations Questionnaire Appearance Evaluation and Body Areas Satisfaction scales (Cash, 2000)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in participants self-reported body image from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Posttraumatic Growth: Posttraumatic Growth Inventory (Tedeschi &amp; Calhoun, 1996)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in participants self-reported posttraumatic growth from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life: Medical Outcomes Study 36-Item Short-Form Health Survey (Ware &amp; Sherbourne, 1992)</measure>
    <time_frame>Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)</time_frame>
    <description>Change in participants self-reported quality of life from baseline, to mid-intervention, to post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Experiences: Qualitative Interviews</measure>
    <time_frame>Baseline (week 0), post-intervention (week 12)</time_frame>
    <description>Participants experiences in the intervention (i.e., with physical activity if in the experimental arm or with engaging in their usual lifestyle if in the wait-list control arm) and subsequent changes, if any, in behavioural, physical, psychological, and quality of life outcomes as explored via qualitative interviews (following an interview schedule containing a series of open-ended questions and probes) from baseline to post-intervention.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cognitive Functioning: Single Open-Ended Question</measure>
    <time_frame>Baseline (week 0), post-intervention (week 12), follow-up (week 24)</time_frame>
    <description>Change in participants responses to a single open-ended question: &quot;Do you ever feel like you have a hard time thinking and/or remembering?&quot; from baseline, to post-intervention, to follow-up.&#xD;
NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive Functioning: Magnetic Resonance Imaging (MRI) Scans</measure>
    <time_frame>Baseline (week 0), post-intervention (week 12), follow-up (week 24)</time_frame>
    <description>Change in participants cognitive functioning, as assessed by a structural scan, a resting state functional MRI (fMRI) procedure, four fMRI tasks, and a diffusion tensor imaging sequence (lasting approximately 60 minutes), from baseline, to post-intervention, to follow-up.&#xD;
NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Socio-Demographic and Medical Information Questionnaire</measure>
    <time_frame>Baseline (week 0)</time_frame>
    <description>The socio-demographic and medical information collected will be used to describe the sample.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Adolescent and Young Adult Cancer Survivors</condition>
  <arm_group>
    <arm_group_label>Physical Activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental arm (i.e., physical activity) will be asked to complete the 12-week home-based physical activity program and to complete all study assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the no intervention arm (i.e., wait-list control) will be asked to maintain their usual lifestyle activities and to complete all study assessments. Participants in this arm will be provided with the 12-week home-based physical activity program in the exact same way as participants in the experimental arm (i.e., physical activity) at the end of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity</intervention_name>
    <description>Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.</description>
    <arm_group_label>Physical Activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          1. Have been diagnosed with cancer for the first time between the ages of 15 and 39&#xD;
             years;&#xD;
&#xD;
          2. Have completed cancer treatment within 5 years;&#xD;
&#xD;
          3. Currently between the ages of 15 to 44 years;&#xD;
&#xD;
          4. Have no current evidence of progressive disease, secondary cancer (i.e., cancer cells&#xD;
             that have spread from the primary cancer), or second cancers (i.e., a new different&#xD;
             cancer);&#xD;
&#xD;
          5. Live within 100 km of the University of Ottawa;&#xD;
&#xD;
          6. Be inactive or insufficiently active as determined by a single item screening question&#xD;
             (i.e., participants must respond &quot;no&quot; to the following question: are you currently&#xD;
             engaging in moderate physical activity, defined as activity that increases your heart&#xD;
             rate and causes you to sweat, on 3 or more days a week?). Screening participants based&#xD;
             on their level of physical activity will ensure only those individuals for whom the&#xD;
             intervention will have the largest effect are recruited;&#xD;
&#xD;
          7. Able to read, understand, and provide informed consent in English;&#xD;
&#xD;
          8. Ready for physical activity as indicated by answering Physical Activity Readiness&#xD;
             Questions (PAR-Q). If participants are not ready for physical activity as determined&#xD;
             by the PAR-Q they will need to complete a Physical Activity Readiness Medical&#xD;
             Examination Form.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Physical impairments precluding participation in physical activity;&#xD;
&#xD;
          2. Unwilling or unable to sign the Participant Informed Consent Form;&#xD;
&#xD;
          3. Received a diagnosis of brain cancer or thyroid cancer. Brain cancer survivors will be&#xD;
             excluded as a function of the cognitive impairments associated with their diagnosis&#xD;
             and treatment and thyroid cancer survivors will be excluded due to the vastly&#xD;
             different treatment regimens. That is, both of these cancers may result in different&#xD;
             physical, psychological/emotional, and social effects that could impact the outcomes&#xD;
             of interest.&#xD;
&#xD;
        Eligible participants who want to participate in the other pre-specified outcome measures&#xD;
        to assess cognitive functioning must also meet the following additional inclusion/exclusion&#xD;
        criteria.&#xD;
&#xD;
        ADDITIONAL INCLUSION CRITERIA:&#xD;
&#xD;
          1. Right-handedness, because language is lateralized and has been shown to be left side&#xD;
             dominant (for right handers) during fMRI tasks;&#xD;
&#xD;
          2. Able to read, understand, and provide informed consent in English for the additional&#xD;
             assessments.&#xD;
&#xD;
        ADDITIONAL EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would&#xD;
             preclude scanning;&#xD;
&#xD;
          2. Claustrophobia;&#xD;
&#xD;
          3. Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli&#xD;
             presented in the scanner;&#xD;
&#xD;
          4. Lower back pain that would preclude a person from lying relatively still for one hour;&#xD;
&#xD;
          5. Substance use disorder as assessed by a single item question (i.e., participants must&#xD;
             respond &quot;no&quot; to the following question: Have you been told, in the last five years, by&#xD;
             your healthcare provider that you have a substance use disorder?).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Brunet, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ottawa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ottawa</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1N 6N5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.</citation>
    <PMID>4053261</PMID>
  </reference>
  <reference>
    <citation>Canadian Society for Exercise Physiology (CSEP). CSEP-Physical activity training for health (CSEP-PATH). Ottawa, ON: CSEP, 2013.</citation>
  </reference>
  <reference>
    <citation>Irwin, ML. American College of Sports Medicine's guide to exercise and cancer survivorship. Champaign, IL: Human Kinetics, 2012.</citation>
  </reference>
  <reference>
    <citation>Rikli R, Jones J. Senior fitness test manual. Champaign, IL: Human Kinetics, 2001.</citation>
  </reference>
  <reference>
    <citation>McAuley E. Self-efficacy and the maintenance of exercise participation in older adults. J Behav Med. 1993 Feb;16(1):103-13. doi: 10.1007/BF00844757.</citation>
    <PMID>8433355</PMID>
  </reference>
  <reference>
    <citation>Marsh HW, Martin AJ, Jackson S. Introducing a short version of the physical self description questionnaire: new strategies, short-form evaluative criteria, and applications of factor analyses. J Sport Exerc Psychol. 2010 Aug;32(4):438-82. doi: 10.1123/jsep.32.4.438. Erratum In: J Sport Exerc Psychol. 2010 Dec;32(6):909-11.</citation>
    <PMID>20733208</PMID>
  </reference>
  <reference>
    <citation>Rosenberg M. Soceity and adolescent self-image. Princeton, NJ: Princeton University Press, 1965.</citation>
  </reference>
  <reference>
    <citation>Cash TF. The multidimensional body-self relations questionnaire. MBSRQ Users' Manual 3rd Revision. Available: http://www.body-images.com, 2000.</citation>
  </reference>
  <reference>
    <citation>Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. doi: 10.1007/BF02103658.</citation>
    <PMID>8827649</PMID>
  </reference>
  <reference>
    <citation>Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.</citation>
    <PMID>1593914</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>May 29, 2019</last_update_submitted>
  <last_update_submitted_qc>May 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Ottawa</investigator_affiliation>
    <investigator_full_name>Jennifer Brunet</investigator_full_name>
    <investigator_title>PhD, Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>physical activity</keyword>
  <keyword>pilot study</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>cancer</keyword>
  <keyword>adolescent and young adult</keyword>
  <keyword>AYA</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03016728
org study id: Ottawa
nct id: NCT03016728
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
More adolescents and young adults are surviving cancer than ever before. Many endure negative
      effects related to their cancer and its treatment, which reduces their quality of life and
      functioning. Physical activity is one strategy that has been shown to promote quality of life
      amongst cancer survivors. However, very little research has focused on adolescent and young
      adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is
      to explore the feasibility, safety, and potential benefits of a 12-week home-based physical
      activity intervention in adolescent and young adult cancer survivors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Recruitment Rates
time frame: Through study completion, an average of 12-24 weeks
description: The number of eligible participants who enrol in the study out of the number who are referred.
measure: Retention Rates
time frame: Through study completion, an average of 12-24 weeks
description: The number of participants completing the intervention and all scheduled assessments.
measure: Adherence Rates
time frame: Through study completion, an average of 12-24 weeks
description: The number of physical activity sessions engaged in out of the total recommended as part of the intervention.
measure: Number of Participants with Adverse Events
time frame: Through study completion, an average of 12-24 weeks
description: The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the physical activity intervention and/or its assessments.
measure: Physical Activity Behaviour: Daily Physical Activity Logbook
time frame: Through study completion, an average of 12-24 weeks
description: Change in daily self-reported daily physical activity from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
measure: Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
description: Change in self-reported physical activity (over the past 7 days) from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
measure: Physical Activity Behaviour: 7-Day Accelerometer Wear (Objective Physical Activity Behaviour)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
description: Change in objective levels of physical activity as measured by accelerometers (Actigraph wGT3XP-BT), which will be worn for a 7 day period from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
measure: Resting Heart Rate
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in resting heart rate, as measured by a heart rate monitor (Polar A300), from baseline, to mid-intervention, to post-intervention.
measure: Blood Pressure
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in resting blood pressure, using a blood pressure monitor (HealthSmart Digital Blood Pressure Monitor), from baseline, to mid-intervention, to post-intervention.
measure: Body Composition: Body Mass Index
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in body mass as determined by a Tanita scale (TBF-310 GS) that uses bioelectrical impedance to assess body composition from baseline, to mid-intervention, to post-intervention.
measure: Aerobic Capacity: 6-Minute Walk Test (CSEP, 2013; Irwin, 2012)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline, to mid-intervention, to post-intervention.
measure: Musculoskeletal Strength: Combined Grip Strength using a Handheld Dynamometer (CSEP, 2013; Irwin, 2012)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline, to mid-intervention, to post-intervention.
measure: Muscular Endurance: 30-Second Sit to Stand Test (Rikli & Jones, 2001)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in muscular endurance (i.e., number of times participants can stand from a seated position in 30 seconds) from baseline, to mid-intervention, to post-intervention.
measure: Self-Efficacy: Single-Item Version of the Exercise Self-Efficacy Scale (McAuley, 1993)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in participants self-reported self-efficacy from baseline, to mid-intervention, to post-intervention.
measure: Physical Competence and Physical Self-Esteem: Physical Self-Description Questionnaire Short-Form Appearance, Strength, Endurance, Body Fat, and Physical Self-Esteem scales (Marsh, Martin, & Jackson, 2010)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in participants self-reported physical competence and physical self-esteem from baseline, to mid-intervention, to post-intervention.
measure: Global Self-Esteem: Rosenberg Global Self-Esteem Scale (Rosenberg, 1965)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in participants self-reported global self-esteem from baseline, to mid-intervention, to post-intervention.
measure: Body Image: Multidimensional Body-Self Relations Questionnaire Appearance Evaluation and Body Areas Satisfaction scales (Cash, 2000)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in participants self-reported body image from baseline, to mid-intervention, to post-intervention.
measure: Posttraumatic Growth: Posttraumatic Growth Inventory (Tedeschi & Calhoun, 1996)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in participants self-reported posttraumatic growth from baseline, to mid-intervention, to post-intervention.
measure: Quality of Life: Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)
time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
description: Change in participants self-reported quality of life from baseline, to mid-intervention, to post-intervention.
measure: Participants Experiences: Qualitative Interviews
time frame: Baseline (week 0), post-intervention (week 12)
description: Participants experiences in the intervention (i.e., with physical activity if in the experimental arm or with engaging in their usual lifestyle if in the wait-list control arm) and subsequent changes, if any, in behavioural, physical, psychological, and quality of life outcomes as explored via qualitative interviews (following an interview schedule containing a series of open-ended questions and probes) from baseline to post-intervention.
measure: Cognitive Functioning: Single Open-Ended Question
time frame: Baseline (week 0), post-intervention (week 12), follow-up (week 24)
description: Change in participants responses to a single open-ended question: "Do you ever feel like you have a hard time thinking and/or remembering?" from baseline, to post-intervention, to follow-up.
NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments.
measure: Cognitive Functioning: Magnetic Resonance Imaging (MRI) Scans
time frame: Baseline (week 0), post-intervention (week 12), follow-up (week 24)
description: Change in participants cognitive functioning, as assessed by a structural scan, a resting state functional MRI (fMRI) procedure, four fMRI tasks, and a diffusion tensor imaging sequence (lasting approximately 60 minutes), from baseline, to post-intervention, to follow-up.
NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments.
measure: Socio-Demographic and Medical Information Questionnaire
time frame: Baseline (week 0)
description: The socio-demographic and medical information collected will be used to describe the sample.
arm group label: Physical Activity
arm group type: Experimental
description: Participants in the experimental arm (i.e., physical activity) will be asked to complete the 12-week home-based physical activity program and to complete all study assessments.
arm group label: Wait-List Control
arm group type: No Intervention
description: Participants in the no intervention arm (i.e., wait-list control) will be asked to maintain their usual lifestyle activities and to complete all study assessments. Participants in this arm will be provided with the 12-week home-based physical activity program in the exact same way as participants in the experimental arm (i.e., physical activity) at the end of the study.
intervention type: Behavioral
intervention name: Physical Activity
description: Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.
arm group label: Physical Activity
criteria: 
gender: All
minimum age: 15 Years
maximum age: 44 Years
healthy volunteers: No
last name: Jennifer Brunet, PhD
role: Principal Investigator
affiliation: University of Ottawa
facility: 
country: Canada
citation: Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PMID: 4053261
citation: Canadian Society for Exercise Physiology (CSEP). CSEP-Physical activity training for health (CSEP-PATH). Ottawa, ON: CSEP, 2013.
citation: Irwin, ML. American College of Sports Medicine's guide to exercise and cancer survivorship. Champaign, IL: Human Kinetics, 2012.
citation: Rikli R, Jones J. Senior fitness test manual. Champaign, IL: Human Kinetics, 2001.
citation: McAuley E. Self-efficacy and the maintenance of exercise participation in older adults. J Behav Med. 1993 Feb;16(1):103-13. doi: 10.1007/BF00844757.
PMID: 8433355
citation: Marsh HW, Martin AJ, Jackson S. Introducing a short version of the physical self description questionnaire: new strategies, short-form evaluative criteria, and applications of factor analyses. J Sport Exerc Psychol. 2010 Aug;32(4):438-82. doi: 10.1123/jsep.32.4.438. Erratum In: J Sport Exerc Psychol. 2010 Dec;32(6):909-11.
PMID: 20733208
citation: Rosenberg M. Soceity and adolescent self-image. Princeton, NJ: Princeton University Press, 1965.
citation: Cash TF. The multidimensional body-self relations questionnaire. MBSRQ Users' Manual 3rd Revision. Available: http://www.body-images.com, 2000.
citation: Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. doi: 10.1007/BF02103658.
PMID: 8827649
citation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PMID: 1593914
responsible party type: Principal Investigator
investigator affiliation: University of Ottawa
investigator full name: Jennifer Brunet
investigator title: PhD, Assistant Professor
sharing ipd: Undecided