<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/NCT03264209</url>
  </required_header>
  <id_info>
    <org_study_id>KC17FNDI0557</org_study_id>
    <nct_id>NCT03264209</nct_id>
  </id_info>
  <brief_title>Smart After-Care in Patients With Prostate Cancer</brief_title>
  <official_title>Smart After-Care in Patients With Prostate Cancer: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ji Youl Lee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul St. Mary's Hospital</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>
      This study aims to examine whether Smart After-Care service (Internet-and mobile-based&#xD;
      lifestyle intervention) has an effect on patients' satisfaction and clinical outcomes in&#xD;
      patients with prostate cancer on androgen deprivation therapy. Patients with prostate cancer&#xD;
      on androgen deprivation therapy will participate in the study. The study design is a&#xD;
      randomized controlled trial. The patients were randomly assigned to intervention or usual&#xD;
      care groups. Intervention patients received Smart After-Care service for 3 months. Primary&#xD;
      endpoint was an increase in patients' physical function as assessed using 2 minute walking&#xD;
      test. Secondary endpoints included improvement in muscle strength, short physical performance&#xD;
      battery, body composition, and health-related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After-care is a process targeted towards restoration or maintenance of the physical, mental,&#xD;
      intellectual and social abilities of an individual affected by cancer. Internet-and&#xD;
      mobile-based lifestyle intervention have emerged as potential modalities to complement and&#xD;
      increase accessibility to after-care. In order to meet the growing need for after-care&#xD;
      services, we developed a Smart after-care system that will assess the efficacy of a web-based&#xD;
      smartphone-enabled intervention. The system provided specialized tools on after-care of&#xD;
      prostate cancer including information on nutrition, physical activity, medication adherence,&#xD;
      and mobile device that can connect to the smartphone. Patients with prostate cancer on&#xD;
      androgen deprivation therapy will be screened for having adequate musculoskeletal and&#xD;
      cardiopulmonary function.The study design is a randomized controlled trial. The patients were&#xD;
      randomly assigned to intervention or usual care groups. Intervention patients received Smart&#xD;
      After-Care management for 3 months. Primary endpoint was an increase in patients' physical&#xD;
      function as assessed using 2 minute walking test. Secondary endpoints included improvement in&#xD;
      muscle strength, short physical performance battery, body composition, and health-related&#xD;
      quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</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>
  </study_design_info>
  <primary_outcome>
    <measure>Physical function (2 minute walking test)</measure>
    <time_frame>3 months after randomization</time_frame>
    <description>Cardiorespiratory endurance was examined by 2MWT performed on a 15.2-m hallway out-and-back course. Patients were instructed to walk as fast as they could until asked to stop at 2 min; the distance covered was recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in muscle strength</measure>
    <time_frame>3 months after randomization</time_frame>
    <description>A handgrip strength test was used to assess upper extremity muscle strength using a hand-held dynamometer. Patients were instructed to apply maximal power for 3 s with the shoulder adducted and neutrally rotated, elbow flexed at 90°, and the forearm and wrist in a neutral position. Three attempts were given with each hand and the best score (kg) for each was recorded. A 30-s chair stand test was used as a measure of lower extremity muscle strength. Each patient was seated in the middle of the chair (seat height of 40 cm, without armrests but with a backrest) with their back straight and both arms folded across their chest. The patients were instructed to stand up and sit down repetitively and encouraged to complete as many full stands as possible for 30 s while the instructor kept count.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in short physical performance battery</measure>
    <time_frame>3 months after randomization</time_frame>
    <description>The SPPB is calculated from three components: the ability to stand for up to 10 seconds with feet positioned in three ways (together side-by-side, semi-tandem and tandem); time to complete a 3-m or 4-m walk; and time to rise from a chair five times.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body composition</measure>
    <time_frame>3 months after randomization</time_frame>
    <description>weight in kilograms, height in meters, body fat mass in kilograms, skeletal muscle mass in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health-related quality of life by EORTC QLQ-C30</measure>
    <time_frame>3 months after randomization</time_frame>
    <description>Units on a Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health-related quality of life by EORTC QLQ-PR25.</measure>
    <time_frame>3 months after randomization</time_frame>
    <description>Units on a Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention: Case management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Case management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care is provided with life style intervention including exercise and nutrition by printed materials.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smart After-Care (Mobile health)</intervention_name>
    <description>Patients in intervention group will be provided with Smart After-Care Service including intervention for physical activity (aerobic exercise at least 90 or 150 minutes every week for 12 weeks depending on patients' aerobic fitness by monitoring with smartband and strengthening exercise at least 2 times a week for 12 weeks), information for prostate cancer and adequate life style, and smartband that can connect to the smartphone. Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.</description>
    <arm_group_label>Intervention: Case management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males diagnosed with prostate cancer&#xD;
&#xD;
          -  Current treatment with ADT (GnRH agonist/antagonist with or without antiandrogen) for&#xD;
             a minimum of 6 months after randomization&#xD;
&#xD;
          -  Having Android smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having another (active) malignant disease within 3 month before randomization&#xD;
&#xD;
          -  Having severe cardiopulmonary disease&#xD;
&#xD;
          -  Having bone pain due to bone metastasis, (or) pathologic fracture&#xD;
&#xD;
          -  Receiving total knee replacement arthroplasty, (or) total hip replacement arthroplasty&#xD;
&#xD;
          -  No permission from treating/study physician to participate in exercise&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ji Youl Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yong Hyun Park, MD, PhD</last_name>
    <phone>82-2-2258-6076</phone>
    <email>lestat04@catholic.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ji Youl Lee</last_name>
      <phone>82-2-2258-6076</phone>
      <email>uroljy@catholic.ac.kr</email>
    </contact>
    <contact_backup>
      <last_name>Yong Hyun Park</last_name>
      <phone>82-2-2258-6076</phone>
      <email>lestat04@catholic.ac.kr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Ji Youl Lee</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <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/NCT03264209
org study id: KC17FNDI0557
nct id: NCT03264209
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to examine whether Smart After-Care service (Internet-and mobile-based
      lifestyle intervention) has an effect on patients' satisfaction and clinical outcomes in
      patients with prostate cancer on androgen deprivation therapy. Patients with prostate cancer
      on androgen deprivation therapy will participate in the study. The study design is a
      randomized controlled trial. The patients were randomly assigned to intervention or usual
      care groups. Intervention patients received Smart After-Care service for 3 months. Primary
      endpoint was an increase in patients' physical function as assessed using 2 minute walking
      test. Secondary endpoints included improvement in muscle strength, short physical performance
      battery, body composition, and health-related quality of life.
After-care is a process targeted towards restoration or maintenance of the physical, mental,
      intellectual and social abilities of an individual affected by cancer. Internet-and
      mobile-based lifestyle intervention have emerged as potential modalities to complement and
      increase accessibility to after-care. In order to meet the growing need for after-care
      services, we developed a Smart after-care system that will assess the efficacy of a web-based
      smartphone-enabled intervention. The system provided specialized tools on after-care of
      prostate cancer including information on nutrition, physical activity, medication adherence,
      and mobile device that can connect to the smartphone. Patients with prostate cancer on
      androgen deprivation therapy will be screened for having adequate musculoskeletal and
      cardiopulmonary function.The study design is a randomized controlled trial. The patients were
      randomly assigned to intervention or usual care groups. Intervention patients received Smart
      After-Care management for 3 months. Primary endpoint was an increase in patients' physical
      function as assessed using 2 minute walking test. Secondary endpoints included improvement in
      muscle strength, short physical performance battery, body composition, and health-related
      quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Physical function (2 minute walking test)
time frame: 3 months after randomization
description: Cardiorespiratory endurance was examined by 2MWT performed on a 15.2-m hallway out-and-back course. Patients were instructed to walk as fast as they could until asked to stop at 2 min; the distance covered was recorded.
measure: Changes in muscle strength
time frame: 3 months after randomization
description: A handgrip strength test was used to assess upper extremity muscle strength using a hand-held dynamometer. Patients were instructed to apply maximal power for 3 s with the shoulder adducted and neutrally rotated, elbow flexed at 90°, and the forearm and wrist in a neutral position. Three attempts were given with each hand and the best score (kg) for each was recorded. A 30-s chair stand test was used as a measure of lower extremity muscle strength. Each patient was seated in the middle of the chair (seat height of 40 cm, without armrests but with a backrest) with their back straight and both arms folded across their chest. The patients were instructed to stand up and sit down repetitively and encouraged to complete as many full stands as possible for 30 s while the instructor kept count.
measure: Changes in short physical performance battery
time frame: 3 months after randomization
description: The SPPB is calculated from three components: the ability to stand for up to 10 seconds with feet positioned in three ways (together side-by-side, semi-tandem and tandem); time to complete a 3-m or 4-m walk; and time to rise from a chair five times.
measure: Changes in body composition
time frame: 3 months after randomization
description: weight in kilograms, height in meters, body fat mass in kilograms, skeletal muscle mass in kilograms
measure: Changes in health-related quality of life by EORTC QLQ-C30
time frame: 3 months after randomization
description: Units on a Scale
measure: Changes in health-related quality of life by EORTC QLQ-PR25.
time frame: 3 months after randomization
description: Units on a Scale
arm group label: Intervention: Case management
arm group type: Experimental
description: Case management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance
arm group label: Control: usual care
arm group type: No Intervention
description: Usual care is provided with life style intervention including exercise and nutrition by printed materials.
intervention type: Behavioral
intervention name: Smart After-Care (Mobile health)
description: Patients in intervention group will be provided with Smart After-Care Service including intervention for physical activity (aerobic exercise at least 90 or 150 minutes every week for 12 weeks depending on patients' aerobic fitness by monitoring with smartband and strengthening exercise at least 2 times a week for 12 weeks), information for prostate cancer and adequate life style, and smartband that can connect to the smartphone. Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.
arm group label: Intervention: Case management
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Ji Youl Lee, MD, PhD
role: Principal Investigator
affiliation: Seoul St. Mary's Hospital
last name: Yong Hyun Park, MD, PhD
phone: 82-2-2258-6076
email: lestat04@catholic.ac.kr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Ji Youl Lee
investigator title: professor
mesh term: Prostatic Neoplasms