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/NCT05989854</url>
    </required_header>
    <id_info>
      <org_study_id>956732-956714-101614486</org_study_id>
      <nct_id>NCT05989854</nct_id>
    </id_info>
    <brief_title>The Remote Study: Investigating the Effects or Online Exercise on Quality of Life in Men With Prostate Cancer</brief_title>
    <official_title>An Individualised 8-week Remote Exercise Intervention to Improve QoL, Cardiometabolic Risk and Physical Activity Level in Men With Prostate Cancer Undergoing ADT Treatment.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Surrey</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Royal Surrey County Hospital NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Surrey</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>
        Currently, there are few opportunities for patients with cancer to have individual exercise&#xD;
        guidance, and this has further been impacted by the Covid-19 pandemic. However, during the&#xD;
        pandemic the use of virtual/remote platforms has been crucial in delivering care to cancer&#xD;
        patients. The investigators think that remote exercise training may also offer a solution to&#xD;
        support positive change in prostate cancer patients. As a result, the investigators have&#xD;
        developed a remote/online exercise programme to explore this further.&#xD;
  &#xD;
        This study will explore the effectiveness of an 8-week remote exercise and behavioural&#xD;
        support intervention, and whether prostate cancer patients feel they benefit from this. The&#xD;
        study also aims to see if this sort of exercise programme can be delivered to more prostate&#xD;
        cancer patients in the future. This project is open to men with prostate cancer on long term&#xD;
        hormone therapy. The intervention will be comprised of one remote supervised session per&#xD;
        week, completed 1-1 using an online platform and up to two additional sessions, depending on&#xD;
        its suitability for the patient, will be prescribed as unsupervised home-based exercise.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Functional Assessment of Cancer Therapy-Prostate</measure>
      <time_frame>t= 0, 4, 8, 16 &amp; 30 weeks</time_frame>
      <description>Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Assessment of Cancer Therapy</measure>
      <time_frame>t= 0, 4, 8, 16 &amp; 30 weeks</time_frame>
      <description>Functional Assessment of Cancer Therapy fatigue (FACIT-f) questionnaire. The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). It has been used frequently in the clinical trial setting (please see appendix 1). Responses to each question are added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Leisure time physical activity</measure>
      <time_frame>t= 0, 4, 8, 16 &amp; 30 weeks</time_frame>
      <description>Godin Leisure Time Exercise Questionnaire. This is a 3 question self-report questionnaire - indirect measure of physical activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity</measure>
      <time_frame>t= 0, 4, 8, 16 &amp; 30 weeks</time_frame>
      <description>The Dukes Activity Status Index. The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular risk</measure>
      <time_frame>t= 0, 4, 8 weeks</time_frame>
      <description>Qrisk3. Estimation of cardiovascular risk based on demographical and physiological parameters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exercise adherence</measure>
      <time_frame>weekly for 8 weeks</time_frame>
      <description>Session adherence. The number of sessions attended, and % of scheduled sessions performed. Every exercise session either completed or not completed over the 8 week intervention period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health status</measure>
      <time_frame>t= 0, 4, 8, 16 &amp; 30 weeks</time_frame>
      <description>eq-5d-5l. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, some problems, severe problems and unable to do. Each level of answer consists of each level of score ranges from 1 to 5. Each participant will have a health status consisting of 5 digits. Using the set of weights from Vietnamese population provided from the EuroGroup, we can convert each EQ-5D health state into a single summary index value. The index value ranges from 0 to 1, higher scores meaning better health quality.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>Exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Exercise arm</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exercise</intervention_name>
      <description>8 week exercise intervention, 3x/wk</description>
      <arm_group_label>Exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have had an orchiectomy OR;&#xD;
  &#xD;
            -  Are receiving a GnRH agonist/antagonist OR;&#xD;
  &#xD;
            -  Are currently receiving Abiraterone, Enzalutamide, Apalutamide or Darolutamide&#xD;
  &#xD;
            -  Long-term retention is planned (intending to remain on the above stated treatments for&#xD;
               at least the next 6 months).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are currently classed as in active treatment i.e. are currently receiving&#xD;
               chemotherapy/radiation therapy (Note: Patients that are included in the study but&#xD;
               after inclusion are moved onto chemo/radiation therapy, will still be able to&#xD;
               participate in the project).&#xD;
  &#xD;
            -  Patients who are stratified as high risk for having a cardiovascular event.&#xD;
  &#xD;
            -  Acute illness; or any musculoskeletal, cardiovascular or neurological disorder that&#xD;
               could inhibit or put them at risk from exercising, as determined by screening and&#xD;
               their clinician.&#xD;
  &#xD;
            -  Men with painful or unstable bony metastases.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ralph Manders, PhD</last_name>
      <phone>+44(0)1483688668</phone>
      <email>r.manders@surrey.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Surrey</name>
        <address>
          <city>Guildford</city>
          <state>Surrey</state>
          <zip>GU2 7XH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Ralph J Manders, PhD</last_name>
        <phone>01483688668</phone>
        <email>r.manders@surrey.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Prostate cancer</keyword>
    <keyword>Exercise</keyword>
    <keyword>Online</keyword>
    <keyword>Quality of Life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No de-identified data will be shared with other researchers to protect patient confidentiality</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/NCT05989854
  org study id: 956732-956714-101614486
  nct id: NCT05989854
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Currently, there are few opportunities for patients with cancer to have individual exercise
        guidance, and this has further been impacted by the Covid-19 pandemic. However, during the
        pandemic the use of virtual/remote platforms has been crucial in delivering care to cancer
        patients. The investigators think that remote exercise training may also offer a solution to
        support positive change in prostate cancer patients. As a result, the investigators have
        developed a remote/online exercise programme to explore this further.
  
        This study will explore the effectiveness of an 8-week remote exercise and behavioural
        support intervention, and whether prostate cancer patients feel they benefit from this. The
        study also aims to see if this sort of exercise programme can be delivered to more prostate
        cancer patients in the future. This project is open to men with prostate cancer on long term
        hormone therapy. The intervention will be comprised of one remote supervised session per
        week, completed 1-1 using an online platform and up to two additional sessions, depending on
        its suitability for the patient, will be prescribed as unsupervised home-based exercise.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Functional Assessment of Cancer Therapy-Prostate
  time frame: t= 0, 4, 8, 16 & 30 weeks
  description: Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.
  measure: Functional Assessment of Cancer Therapy
  time frame: t= 0, 4, 8, 16 & 30 weeks
  description: Functional Assessment of Cancer Therapy fatigue (FACIT-f) questionnaire. The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). It has been used frequently in the clinical trial setting (please see appendix 1). Responses to each question are added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.
  measure: Leisure time physical activity
  time frame: t= 0, 4, 8, 16 & 30 weeks
  description: Godin Leisure Time Exercise Questionnaire. This is a 3 question self-report questionnaire - indirect measure of physical activity
  measure: Physical activity
  time frame: t= 0, 4, 8, 16 & 30 weeks
  description: The Dukes Activity Status Index. The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs).
  measure: Cardiovascular risk
  time frame: t= 0, 4, 8 weeks
  description: Qrisk3. Estimation of cardiovascular risk based on demographical and physiological parameters
  measure: Exercise adherence
  time frame: weekly for 8 weeks
  description: Session adherence. The number of sessions attended, and % of scheduled sessions performed. Every exercise session either completed or not completed over the 8 week intervention period
  measure: Health status
  time frame: t= 0, 4, 8, 16 & 30 weeks
  description: eq-5d-5l. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, some problems, severe problems and unable to do. Each level of answer consists of each level of score ranges from 1 to 5. Each participant will have a health status consisting of 5 digits. Using the set of weights from Vietnamese population provided from the EuroGroup, we can convert each EQ-5D health state into a single summary index value. The index value ranges from 0 to 1, higher scores meaning better health quality.
  arm group label: Exercise
  arm group type: Experimental
  description: Exercise arm
  intervention type: Behavioral
  intervention name: Exercise
  description: 8 week exercise intervention, 3x/wk
  arm group label: Exercise
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Ralph Manders, PhD
  phone: +44(0)1483688668
  email: r.manders@surrey.ac.uk
  facility: 
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: No
  ipd description: No de-identified data will be shared with other researchers to protect patient confidentiality