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/NCT06011499</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00025281</org_study_id>
      <secondary_id>NCI-2023-03141</secondary_id>
      <secondary_id>STUDY00025281</secondary_id>
      <secondary_id>R01CA275055</secondary_id>
      <nct_id>NCT06011499</nct_id>
    </id_info>
    <brief_title>Internet-Based Lifestyle Intervention (iLIVE) to Eradicate Obese Frailty in Prostate Cancer Survivors</brief_title>
    <acronym>iLIVE</acronym>
    <official_title>Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>OHSU Knight Cancer Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Oregon Health and Science University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Alabama at Birmingham</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>OHSU Knight Cancer Institute</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>
        This clinical trial tests the effectiveness of an online weight loss plus resistance training&#xD;
        intervention (iLIVE) to decrease obesity and improve frailty in men with prostate cancer who&#xD;
        received androgen deprivation therapy (ADT). Androgen deprivation therapy increases the risk&#xD;
        of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty&#xD;
        and obesity can lead to a decrease in quality of life and an increased risk of recurrent&#xD;
        falls. Using iLIVE may improve obesity and frailty in men with prostate cancer who receive&#xD;
        ADT.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To test the effectiveness of a combined online weight loss plus resistance training&#xD;
        intervention (iLIVE) on obese frailty in prostate cancer survivors (PCS) on ADT.&#xD;
  &#xD;
        SECONDARY OBJECTIVE:&#xD;
  &#xD;
        I. To grasp iLIVE's implementation context and outcomes.&#xD;
  &#xD;
        OUTLINE: Patients are randomized to arm I or II. Key stakeholders are assigned to arm III.&#xD;
  &#xD;
        ARM I: Patients receive online access to an interactive weight loss website and participate&#xD;
        in online group based resistance training sessions (iLIVE) on study. Patients also use a&#xD;
        Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.&#xD;
  &#xD;
        ARM II: Patients receive usual care with access to online survivorship and exercise&#xD;
        recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale&#xD;
        while on study.&#xD;
  &#xD;
        Patients are followed for 6 months after completion of intervention.&#xD;
  &#xD;
        ARM III: Key stakeholders complete an interview while on study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2027</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>Single (Outcomes Assessor)</masking>
      <masking_description>Adverse events will be reviewed on a quarterly basis by the research team in a blinded fashion</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in obesity</measure>
      <time_frame>At baseline, 3 months, 6 months and 12 months</time_frame>
      <description>Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Obesity is defined as body mass index &gt; 30kg/m^2 and a 5% loss will be viewed as a successful outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in sarcopenia</measure>
      <time_frame>At baseline, 6 months, and 12 months</time_frame>
      <description>Measured by 30 mg D3 creatine (D3Cr) capsule which they will ingest and then urinate on a test strip on the second void upon waking 3-6 days later. The enrichment of D3Cr will be measured from the test strip along with urine creatine and creatinine. Will use a cutoff of &lt; 10.75 kg/m^2 (moderate sarcopenia).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in slowness</measure>
      <time_frame>At baseline, 3 months, 6 months, and 12 months</time_frame>
      <description>Measured by the fastest time of two 4m walks at a usual pace administered by study staff by remote teleconference. Will use a cut point for &quot;slowness&quot; in older men of speed &lt; 1.0 m/s - a clinically meaningful cutoff that predicts falls and loss of independence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in weakness</measure>
      <time_frame>At baseline, 3 months, 6 months, and 12 months</time_frame>
      <description>Measured by the seconds required to rise from a chair five times, administered by study staff by remote teleconference. Chair stand time &gt; 12 seconds predicts a 2.4 increased risk of falls in older adults and we will apply this cutoff for &quot;weakness.&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in inactivity</measure>
      <time_frame>At baseline, 3 months, 6 months, and 12 months</time_frame>
      <description>Measured by physical activity-related energy expenditure, calculated from self-report on the 41-item Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire. We will use &lt; 383 kcals per week spent in moderate-vigorous intensity activity as our low activity cut point. Measured also by Fitbit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in frailty</measure>
      <time_frame>At baseline, 3 months, 6 months, and 12 months</time_frame>
      <description>Measured using the 4-item short form (SF)-36 Vitality Scale. Will use cut points of scores of &lt; 50.00 (normed) for prostate cancer survivors (PCS) aged 50-64 years or scores less than 40.00 (normed) for PCS aged 65+ years.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in health behaviors</measure>
      <time_frame>At baseline, 3 months, 6 months, and 12 months</time_frame>
      <description>Dietary intake measured using a 2-day diet recalls of 1-weekday and 1 weekend day will be collected by a registered dietitian via telephone and entered into the National Cancer Institute-developed Automated Self-Administered 24-hour. Physical activity measured using CHAMPS as described above. We will also assess free-living physical activity over 7-days using Fitbits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in physical functioning</measure>
      <time_frame>At baseline, 3 months, 6 months, 12 months</time_frame>
      <description>Measured by Timed Up and Go using a widely used clinical measure of functional mobility that evaluates the time it takes to rise from a chair, walk 3m, turn around, and return and sit in the chair. SF-36 Physical Function measured using a 10-item physical function subscale of the SF-36.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life</measure>
      <time_frame>At baseline, 3 months, 6 months, and 12 months</time_frame>
      <description>Measured by European Quality of Life-5D with 1 question in 5 separate domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Scores will also be used to calculate Quality of Life Adjusted Years for cost-effectiveness analysis. Healthcare utilization measured using a brief questionnaire that assesses physician and emergency room visits, hospitalizations, etc.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">255</enrollment>
    <condition>Prostate Carcinoma</condition>
    <arm_group>
      <arm_group_label>Arm I (iLIVE)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ARM I: Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria smart scale while on study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm II (Usual care)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients receive usual care with access to online survivorship and exercise recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm III (Interview)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Key stakeholders complete an interview while on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise Intervention</intervention_name>
      <description>Participate in online group based resistance training sessions</description>
      <arm_group_label>Arm I (iLIVE)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Internet-Based Intervention</intervention_name>
      <description>Receive online access to an interactive website with a series of weekly self-directed and interactive sessions on various topics associated with diet and weight loss (iLIVE)</description>
      <arm_group_label>Arm I (iLIVE)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Internet-Based Intervention</intervention_name>
      <description>Receive usual care with online access to survivorship and exercise recommendation</description>
      <arm_group_label>Arm II (Usual care)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interview</intervention_name>
      <description>Complete an interview</description>
      <arm_group_label>Arm III (Interview)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm I (iLIVE)</arm_group_label>
      <arm_group_label>Arm II (Usual care)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Age 18 or older&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Diagnosed with histologically confirmed prostate cancer&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Received &gt;= 6 months of ADT any time in the past 10 years&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Obese but not class III morbidly obese (Body mass index&#xD;
               [BMI] &gt; 30 kg/m^2 to BMI &lt; 50)&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the&#xD;
               following frailty criteria: weakness, slowness, fatigue, inactivity, and/or unexpected&#xD;
               weight loss&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or exercise&#xD;
               program&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Willing to be randomized into either study arm and adhere&#xD;
               to study protocol&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Home internet sufficient for videoconferencing&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Signed informed consent&#xD;
  &#xD;
            -  IMPLEMENTATION PARTICIPANTS: Be a key stakeholder (i.e., healthcare provider or&#xD;
               administrative, or intervention participant [completers, partial completers, or no&#xD;
               participation])&#xD;
  &#xD;
            -  IMPLEMENTATION PARTICIPANTS: Verbal informed consent following review of an&#xD;
               information sheet&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Contraindication to moderate intensity exercise&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Health or medical condition that affects weight status/body&#xD;
               composition (e.g., Cushing's syndrome, uncontrolled hyper-/hypo- thyroidism)&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Active malignancy (other than non-melanoma skin cancer)&#xD;
  &#xD;
            -  INTERVENTION PARTICIPANTS: Not fluent in English and therefore incapable of answer&#xD;
               survey questions, following directions during exercise or performance testing, and&#xD;
               providing informed consent in English&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kerri Winters-Stone</last_name>
      <role>Principal Investigator</role>
      <affiliation>OHSU Knight Cancer Institute</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>OHSU Knight Cancer Institute</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97239</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kerri Winters-Stone</last_name>
        <phone>503-494-0813</phone>
        <email>wintersk@ohsu.edu</email>
      </contact>
      <investigator>
        <last_name>Kerri Winters-Stone</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>OHSU Knight Cancer Institute</investigator_affiliation>
      <investigator_full_name>Kerri Winters</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <!-- 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/NCT06011499
  org study id: STUDY00025281
  secondary id: NCI-2023-03141
  secondary id: STUDY00025281
  secondary id: R01CA275055
  nct id: NCT06011499
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial tests the effectiveness of an online weight loss plus resistance training
        intervention (iLIVE) to decrease obesity and improve frailty in men with prostate cancer who
        received androgen deprivation therapy (ADT). Androgen deprivation therapy increases the risk
        of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty
        and obesity can lead to a decrease in quality of life and an increased risk of recurrent
        falls. Using iLIVE may improve obesity and frailty in men with prostate cancer who receive
        ADT.
  PRIMARY OBJECTIVE:
  
        I. To test the effectiveness of a combined online weight loss plus resistance training
        intervention (iLIVE) on obese frailty in prostate cancer survivors (PCS) on ADT.
  
        SECONDARY OBJECTIVE:
  
        I. To grasp iLIVE's implementation context and outcomes.
  
        OUTLINE: Patients are randomized to arm I or II. Key stakeholders are assigned to arm III.
  
        ARM I: Patients receive online access to an interactive weight loss website and participate
        in online group based resistance training sessions (iLIVE) on study. Patients also use a
        Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.
  
        ARM II: Patients receive usual care with access to online survivorship and exercise
        recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale
        while on study.
  
        Patients are followed for 6 months after completion of intervention.
  
        ARM III: Key stakeholders complete an interview while on study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  masking description: Adverse events will be reviewed on a quarterly basis by the research team in a blinded fashion
  measure: Change in obesity
  time frame: At baseline, 3 months, 6 months and 12 months
  description: Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Obesity is defined as body mass index > 30kg/m^2 and a 5% loss will be viewed as a successful outcome.
  measure: Change in sarcopenia
  time frame: At baseline, 6 months, and 12 months
  description: Measured by 30 mg D3 creatine (D3Cr) capsule which they will ingest and then urinate on a test strip on the second void upon waking 3-6 days later. The enrichment of D3Cr will be measured from the test strip along with urine creatine and creatinine. Will use a cutoff of < 10.75 kg/m^2 (moderate sarcopenia).
  measure: Change in slowness
  time frame: At baseline, 3 months, 6 months, and 12 months
  description: Measured by the fastest time of two 4m walks at a usual pace administered by study staff by remote teleconference. Will use a cut point for "slowness" in older men of speed < 1.0 m/s - a clinically meaningful cutoff that predicts falls and loss of independence.
  measure: Change in weakness
  time frame: At baseline, 3 months, 6 months, and 12 months
  description: Measured by the seconds required to rise from a chair five times, administered by study staff by remote teleconference. Chair stand time > 12 seconds predicts a 2.4 increased risk of falls in older adults and we will apply this cutoff for "weakness."
  measure: Change in inactivity
  time frame: At baseline, 3 months, 6 months, and 12 months
  description: Measured by physical activity-related energy expenditure, calculated from self-report on the 41-item Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire. We will use < 383 kcals per week spent in moderate-vigorous intensity activity as our low activity cut point. Measured also by Fitbit.
  measure: Change in frailty
  time frame: At baseline, 3 months, 6 months, and 12 months
  description: Measured using the 4-item short form (SF)-36 Vitality Scale. Will use cut points of scores of < 50.00 (normed) for prostate cancer survivors (PCS) aged 50-64 years or scores less than 40.00 (normed) for PCS aged 65+ years.
  measure: Change in health behaviors
  time frame: At baseline, 3 months, 6 months, and 12 months
  description: Dietary intake measured using a 2-day diet recalls of 1-weekday and 1 weekend day will be collected by a registered dietitian via telephone and entered into the National Cancer Institute-developed Automated Self-Administered 24-hour. Physical activity measured using CHAMPS as described above. We will also assess free-living physical activity over 7-days using Fitbits.
  measure: Change in physical functioning
  time frame: At baseline, 3 months, 6 months, 12 months
  description: Measured by Timed Up and Go using a widely used clinical measure of functional mobility that evaluates the time it takes to rise from a chair, walk 3m, turn around, and return and sit in the chair. SF-36 Physical Function measured using a 10-item physical function subscale of the SF-36.
  measure: Change in quality of life
  time frame: At baseline, 3 months, 6 months, and 12 months
  description: Measured by European Quality of Life-5D with 1 question in 5 separate domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Scores will also be used to calculate Quality of Life Adjusted Years for cost-effectiveness analysis. Healthcare utilization measured using a brief questionnaire that assesses physician and emergency room visits, hospitalizations, etc.
  arm group label: Arm I (iLIVE)
  arm group type: Experimental
  description: ARM I: Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria smart scale while on study.
  arm group label: Arm II (Usual care)
  arm group type: Active Comparator
  description: Patients receive usual care with access to online survivorship and exercise recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.
  arm group label: Arm III (Interview)
  arm group type: Experimental
  description: Key stakeholders complete an interview while on study.
  intervention type: Other
  intervention name: Exercise Intervention
  description: Participate in online group based resistance training sessions
  arm group label: Arm I (iLIVE)
  intervention type: Other
  intervention name: Internet-Based Intervention
  description: Receive online access to an interactive website with a series of weekly self-directed and interactive sessions on various topics associated with diet and weight loss (iLIVE)
  arm group label: Arm I (iLIVE)
  intervention type: Other
  intervention name: Internet-Based Intervention
  description: Receive usual care with online access to survivorship and exercise recommendation
  arm group label: Arm II (Usual care)
  intervention type: Other
  intervention name: Interview
  description: Complete an interview
  arm group label: Arm III (Interview)
  intervention type: Other
  intervention name: Survey Administration
  description: Ancillary studies
  arm group label: Arm I (iLIVE)
  arm group label: Arm II (Usual care)
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Kerri Winters-Stone
  role: Principal Investigator
  affiliation: OHSU Knight Cancer Institute
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: OHSU Knight Cancer Institute
  investigator full name: Kerri Winters
  investigator title: Principal Investigator
  mesh term: Frailty