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/NCT05988892</url>
    </required_header>
    <id_info>
      <org_study_id>23-001462</org_study_id>
      <secondary_id>NCI-2023-05387</secondary_id>
      <nct_id>NCT05988892</nct_id>
    </id_info>
    <brief_title>A Study of Physical Activity in Cancer Survivors</brief_title>
    <official_title>Improving Physical Activity in Rural and Older Cancer Survivors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to determine if increasing physical activity (PA) will increase&#xD;
        physical functioning, as measured by cardiovascular endurance, muscular strength, and balance&#xD;
        in underserved adult cancer survivors &gt; 60 years of age and/or those of any age residing at a&#xD;
        rural address. Also, to determine if increasing PA will increase quality of life (QOL), as&#xD;
        measured by physical functioning and fatigue, in underserved cancer survivors &gt;60 years of&#xD;
        age and/or those of any age residing at a rural address.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 23, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in physical functioning using Short Physical Performance Battery</measure>
      <time_frame>Baseline; 12 weeks</time_frame>
      <description>Change in physical functioning based on improvement in endurance, strength, and balance assessed using Short Physical Performance Battery (SPPB) pre- and post-12-week exercise intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Quality of Life (QOL) using Patient-Reported Outcomes Measurement Information System (PROMIS)</measure>
      <time_frame>Baseline; 12 weeks</time_frame>
      <description>QOL evaluated based on physical functioning and fatigue, assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) pre- and post-12-week exercise intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in satisfaction using a 5-point Likert scale</measure>
      <time_frame>Baseline; 12 weeks</time_frame>
      <description>Satisfaction assessed using a 5-point Likert scale following 12-week exercise intervention and participant-reporting likelihood of recommending program.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of adherence to program based on participation in virtual exercise sessions</measure>
      <time_frame>Baseline; 12 weeks</time_frame>
      <description>Adherence evaluated based on participation in virtual exercise sessions during 12-week exercise intervention.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Community Oncology patients entering cancer survivorship</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients participate in a virtual cancer rehabilitation program with weekly virtual visits by a cancer exercise specialist who provides a personalized synchronous exercise plan and receive weekly phone calls over 12 weeks. Patents also wear a Fitbit on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Physical Activity</intervention_name>
      <description>Use Exercise to increase physical activity (PA), as measured by cardiovascular endurance, muscular strength, and balance in underserved cancer survivors &gt;60 years of age and/or those of any age residing at a rural address and to increase quality of life (QOL), as measured by physical functioning and fatigue, in underserved cancer survivors &gt;60 years of age and/or those of any age residing at a rural address.</description>
      <arm_group_label>Community Oncology patients entering cancer survivorship</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult, cancer survivors (no active disease) at Mayo Clinic Health System (MCHS) in&#xD;
               Northwest Wisconsin (NWWI)&#xD;
  &#xD;
            -  Any stage cancer&#xD;
  &#xD;
            -  Age ≥60 years residing at any address, or ≥18 years residing at a rural address (as&#xD;
               defined by Rural America, census.gov)&#xD;
  &#xD;
            -  Completed active treatment of surgery, (neo)adjuvant chemotherapy, and/or (neo)&#xD;
               adjuvant radiation. Patients receiving adjuvant endocrine therapy, targeted therapy,&#xD;
               or immunotherapy therapies are eligible.&#xD;
  &#xD;
            -  Ownership of a computer/tablet/smartphone with internet access.&#xD;
  &#xD;
            -  Willingness and ability to attend study visits.&#xD;
  &#xD;
            -  Must be able to complete semi-tandem (10 seconds), side-by-side tandem (10 seconds and&#xD;
               SPPB Score of &gt;6 to qualify for virtual exercise.&#xD;
  &#xD;
            -  Must be ambulatory without the use of assisted device(s).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Receiving surgery, (neo)adjuvant chemotherapy, (neo) adjuvant radiation, palliative&#xD;
               treatment&#xD;
  &#xD;
            -  Are already performing &gt;150 minutes/week of moderate activity or 75 min/week of&#xD;
               vigorous physical activity&#xD;
  &#xD;
            -  Cancer-free for greater than 5 years&#xD;
  &#xD;
            -  Unable to complete weekly interventions/exercise due to traveling or unable to be&#xD;
               active for more than 7 consecutive days.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kaye T. Sturz, APRN, CNP</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic Health System in Eau Claire</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sara Herrick</last_name>
      <phone>507-422-9514</phone>
      <email>Herrick.Sara@mayo.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mayo Clinic Health System-Eau Claire Clinic</name>
        <address>
          <city>Eau Claire</city>
          <state>Wisconsin</state>
          <zip>54701</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <contact_backup>
        <last_name>Sara Herrick</last_name>
        <phone>507-422-9514</phone>
        <email>Herrick.Sara@mayo.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Kaye T. Sturz, APRN, CNP</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Rural</keyword>
    <keyword>Physical Activity</keyword>
    <!-- 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/NCT05988892
  org study id: 23-001462
  secondary id: NCI-2023-05387
  nct id: NCT05988892
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine if increasing physical activity (PA) will increase
        physical functioning, as measured by cardiovascular endurance, muscular strength, and balance
        in underserved adult cancer survivors > 60 years of age and/or those of any age residing at a
        rural address. Also, to determine if increasing PA will increase quality of life (QOL), as
        measured by physical functioning and fatigue, in underserved cancer survivors >60 years of
        age and/or those of any age residing at a rural address.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Change in physical functioning using Short Physical Performance Battery
  time frame: Baseline; 12 weeks
  description: Change in physical functioning based on improvement in endurance, strength, and balance assessed using Short Physical Performance Battery (SPPB) pre- and post-12-week exercise intervention.
  measure: Change in Quality of Life (QOL) using Patient-Reported Outcomes Measurement Information System (PROMIS)
  time frame: Baseline; 12 weeks
  description: QOL evaluated based on physical functioning and fatigue, assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) pre- and post-12-week exercise intervention.
  measure: Change in satisfaction using a 5-point Likert scale
  time frame: Baseline; 12 weeks
  description: Satisfaction assessed using a 5-point Likert scale following 12-week exercise intervention and participant-reporting likelihood of recommending program.
  measure: Rate of adherence to program based on participation in virtual exercise sessions
  time frame: Baseline; 12 weeks
  description: Adherence evaluated based on participation in virtual exercise sessions during 12-week exercise intervention.
  arm group label: Community Oncology patients entering cancer survivorship
  arm group type: Experimental
  description: Patients participate in a virtual cancer rehabilitation program with weekly virtual visits by a cancer exercise specialist who provides a personalized synchronous exercise plan and receive weekly phone calls over 12 weeks. Patents also wear a Fitbit on study.
  intervention type: Behavioral
  intervention name: Physical Activity
  description: Use Exercise to increase physical activity (PA), as measured by cardiovascular endurance, muscular strength, and balance in underserved cancer survivors >60 years of age and/or those of any age residing at a rural address and to increase quality of life (QOL), as measured by physical functioning and fatigue, in underserved cancer survivors >60 years of age and/or those of any age residing at a rural address.
  arm group label: Community Oncology patients entering cancer survivorship
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kaye T. Sturz, APRN, CNP
  role: Principal Investigator
  affiliation: Mayo Clinic Health System in Eau Claire
  last name: Clinical Trials Referral Office
  phone: 855-776-0015
  email: mayocliniccancerstudies@mayo.edu
  last name: Sara Herrick
  phone: 507-422-9514
  email: Herrick.Sara@mayo.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Sponsor