<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/NCT02969577</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004205</org_study_id>
    <secondary_id>R01NR014518</secondary_id>
    <nct_id>NCT02969577</nct_id>
  </id_info>
  <brief_title>Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men</brief_title>
  <official_title>Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to learn if lifestyle changes and counseling along with standard&#xD;
      medical care, compared to standard medical care alone, can prevent heart problems and&#xD;
      diabetes in men who are receiving ADT for prostate cancer treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer is a very treatable cancer but those treatments can have long-lasting&#xD;
      effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used&#xD;
      along with other treatments like radiation and has been shown to improve survival. However,&#xD;
      ADT can have negative effects especially on the heart and metabolism (the body's system for&#xD;
      using and storing energy).&#xD;
&#xD;
      Participation in this study will last for up to 12 months. The study is looking at two&#xD;
      different approaches to treating men who are undergoing ADT:&#xD;
&#xD;
        1. Staying Strong &amp; Healthy Intervention + Usual Care&#xD;
&#xD;
        2. Usual Care&#xD;
&#xD;
      All participants will have blood drawn and be asked questions about how they are feeling&#xD;
      during their participation. The men in the Staying Strong &amp; Healthy Intervention group will&#xD;
      also take part in a diet and exercise program and receive counseling from a member of the&#xD;
      study team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2017</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Change in LDL</measure>
    <time_frame>Change from Baseline to Month 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI)</measure>
    <time_frame>Change from Baseline to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI)</measure>
    <time_frame>Change from Baseline to Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lipid Profile</measure>
    <time_frame>Change from Baseline to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lipid Profile</measure>
    <time_frame>Change from Baseline to Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist/Hip Circumference</measure>
    <time_frame>Change from Baseline to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist/Hip Circumference</measure>
    <time_frame>Change from Baseline to Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Glucose</measure>
    <time_frame>Change from Baseline to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Glucose</measure>
    <time_frame>Change from Baseline to Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health Related Quality</measure>
    <time_frame>Change from Baseline to Month 6</time_frame>
    <description>Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health Related Quality</measure>
    <time_frame>Change from Baseline to Month 12</time_frame>
    <description>Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Staying Strong &amp; Healthy Intervention (SS&amp;H)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take part in a 6-month exercise program and diet and nutrition coaching program. Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team. Participants will also receive the usual care they would normally receive if not taking part in this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care with Attention (UCA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive the usual care they would normally receive if not taking part in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Program</intervention_name>
    <description>Participants will have a personal training session at the first visit. A member of the study team will discuss strength training and cardiovascular workouts for them to complete over the first 6 months of the study. A member of the study team will then talk with the participant every week for the first 3 months and monthly afterwards until month 6. Participants will be sent exercise videos and be given recommendations for the exercise program via phone calls and will be tailored to the individual. Videos and recommendations will be sent directly to the participant's smartphone.</description>
    <arm_group_label>Staying Strong &amp; Healthy Intervention (SS&amp;H)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diet and Nutrition Coaching</intervention_name>
    <description>Diet and nutrition coaching session with an overview of resources on the smartphone. Over the first 6 months, participants will receive healthy recipes and nutritional information on the smartphone.</description>
    <arm_group_label>Staying Strong &amp; Healthy Intervention (SS&amp;H)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care with Attention</intervention_name>
    <description>Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.</description>
    <arm_group_label>Staying Strong &amp; Healthy Intervention (SS&amp;H)</arm_group_label>
    <arm_group_label>Usual Care with Attention (UCA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with prostate cancer&#xD;
&#xD;
          -  Starting or have started ADT (oral or injection) for prostate cancer treatment within&#xD;
             the last 3 months&#xD;
&#xD;
          -  Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the&#xD;
             man's dosage is every six months and he has been off ADT for more than six he is&#xD;
             eligible);&#xD;
&#xD;
          -  Able to speak and read in English or Spanish&#xD;
&#xD;
          -  Reachable consistently by telephone&#xD;
&#xD;
          -  Able to travel to KUMC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not diagnosed with prostate cancer&#xD;
&#xD;
          -  Not receiving or planning to receive ADT for prostate cancer treatment within the last&#xD;
             three months&#xD;
&#xD;
          -  Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT&#xD;
             holiday&#xD;
&#xD;
          -  Not able to speak and read in English or Spanish&#xD;
&#xD;
          -  Not reachable consistently by telephone&#xD;
&#xD;
          -  Not able to travel to the study site for data collection&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sally Maliski, PhD, RN, FAAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Androgen deprivation therapy</keyword>
  <keyword>ADT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02969577
org study id: STUDY00004205
secondary id: R01NR014518
nct id: NCT02969577
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to learn if lifestyle changes and counseling along with standard
      medical care, compared to standard medical care alone, can prevent heart problems and
      diabetes in men who are receiving ADT for prostate cancer treatment.
Prostate cancer is a very treatable cancer but those treatments can have long-lasting
      effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used
      along with other treatments like radiation and has been shown to improve survival. However,
      ADT can have negative effects especially on the heart and metabolism (the body's system for
      using and storing energy).

      Participation in this study will last for up to 12 months. The study is looking at two
      different approaches to treating men who are undergoing ADT:

        1. Staying Strong & Healthy Intervention + Usual Care

        2. Usual Care

      All participants will have blood drawn and be asked questions about how they are feeling
      during their participation. The men in the Staying Strong & Healthy Intervention group will
      also take part in a diet and exercise program and receive counseling from a member of the
      study team.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in LDL
time frame: Change from Baseline to Month 12
measure: Change in Body Mass Index (BMI)
time frame: Change from Baseline to Month 6
measure: Change in Body Mass Index (BMI)
time frame: Change from Baseline to Month 12
measure: Change in Lipid Profile
time frame: Change from Baseline to Month 6
measure: Change in Lipid Profile
time frame: Change from Baseline to Month 12
measure: Change in Waist/Hip Circumference
time frame: Change from Baseline to Month 6
measure: Change in Waist/Hip Circumference
time frame: Change from Baseline to Month 12
measure: Change in Glucose
time frame: Change from Baseline to Month 6
measure: Change in Glucose
time frame: Change from Baseline to Month 12
measure: Change in Health Related Quality
time frame: Change from Baseline to Month 6
description: Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.
measure: Change in Health Related Quality
time frame: Change from Baseline to Month 12
description: Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.
arm group label: Staying Strong & Healthy Intervention (SS&H)
arm group type: Experimental
description: Participants will take part in a 6-month exercise program and diet and nutrition coaching program. Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team. Participants will also receive the usual care they would normally receive if not taking part in this study.
arm group label: Usual Care with Attention (UCA)
arm group type: Active Comparator
description: Participants will receive the usual care they would normally receive if not taking part in this study.
intervention type: Behavioral
intervention name: Exercise Program
description: Participants will have a personal training session at the first visit. A member of the study team will discuss strength training and cardiovascular workouts for them to complete over the first 6 months of the study. A member of the study team will then talk with the participant every week for the first 3 months and monthly afterwards until month 6. Participants will be sent exercise videos and be given recommendations for the exercise program via phone calls and will be tailored to the individual. Videos and recommendations will be sent directly to the participant's smartphone.
arm group label: Staying Strong & Healthy Intervention (SS&H)
intervention type: Behavioral
intervention name: Diet and Nutrition Coaching
description: Diet and nutrition coaching session with an overview of resources on the smartphone. Over the first 6 months, participants will receive healthy recipes and nutritional information on the smartphone.
arm group label: Staying Strong & Healthy Intervention (SS&H)
intervention type: Other
intervention name: Usual Care with Attention
description: Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.
arm group label: Staying Strong & Healthy Intervention (SS&H)
arm group label: Usual Care with Attention (UCA)
criteria: 
gender: Male
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Sally Maliski, PhD, RN, FAAN
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms