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/NCT06016504</url>
    </required_header>
    <id_info>
      <org_study_id>21-002955</org_study_id>
      <secondary_id>NCI-2022-09812</secondary_id>
      <secondary_id>21-002955</secondary_id>
      <nct_id>NCT06016504</nct_id>
    </id_info>
    <brief_title>Adaptive Virtual Consultation Tool to Enhance Education and Understanding in Patients With Prostate Cancer</brief_title>
    <official_title>Development and Evaluation of an Adaptive Virtual Consultation Tool for Prostate Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</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 clinical trial aims to design and validate an adaptive virtual consultation tool (AVCT)&#xD;
        for men with prostate cancer (PC). An AVCT utilizes health literacy assessments in&#xD;
        combination with learning preferences and individual disease characteristics to provide&#xD;
        focused and guided knowledge on PC tailored to the individual patient. Using an AVCT to&#xD;
        enhance patient education may improve patient understanding and result in higher patient&#xD;
        satisfaction with treatment decisions amongst men with PC.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. To develop an adaptive virtual consultation tool for PC (AVCT):&#xD;
  &#xD;
        Ia. To incorporate and integrate the inputs from a diverse group of patients (including&#xD;
        minorities), patient advocates, nursing, physicians and education experts in the design&#xD;
        process for the adaptive consultation tool; Ib. Employ user centered iterative design&#xD;
        approach to develop an adaptive learning tool on mobile devices that is tailored to&#xD;
        individuals based on symptoms, health literacy, learning style, and disease specific&#xD;
        characteristics.&#xD;
  &#xD;
        II. To assess the feasibility, acceptability and usability of AVCT:&#xD;
  &#xD;
        IIa. To validate the design approach and customization rules at the completion of the&#xD;
        participatory design process using a convenience sample of subjects through assessment of&#xD;
        system interaction logs and qualitative feedback from users on cognition, ease-of-use,&#xD;
        usability and customization efficacy; IIb. To utilize the feasibility study results in (2a)&#xD;
        to refine the interface, information presentation, and adaptive customization approach.&#xD;
  &#xD;
        III. To determine the efficacy of AVCT using a small-scale comparative study:&#xD;
  &#xD;
        IIIa. To design and execute a three arm comparative study consisting of adaptive virtual&#xD;
        consultation, non-adaptive virtual consultation and standard-practice information-only&#xD;
        control intervention and assess the comparative efficacy of the tool on the main outcome&#xD;
        variable, satisfaction with health care episode; IIIb. To measure changes in other outcome&#xD;
        variables at baseline, post-intervention, 3-month and 12-month duration; IIIc. To analyze the&#xD;
        mediating influence of decision self-efficacy and a number of moderating factors including&#xD;
        preference for decision-making participation and health literacy on outcome variables.&#xD;
  &#xD;
        OUTLINE: Patients are randomized to 1 of 3 arms.&#xD;
  &#xD;
        ARM 1: Patients participate in an adaptive virtual consultation on trial.&#xD;
  &#xD;
        ARM 2: Patients participate in a non-adaptive virtual consultation on trial.&#xD;
  &#xD;
        ARM 3: Patients receive information-only on trial.&#xD;
  &#xD;
        After completion of study intervention, patients are followed up at 3- and 12-months post&#xD;
        treatment decision.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 10, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient satisfaction measured by post utilization surveys</measure>
      <time_frame>3-month post treatment decision</time_frame>
      <description>Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools.&#xD;
  Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient satisfaction measured by post utilization surveys</measure>
      <time_frame>12-month post treatment decision</time_frame>
      <description>Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools.&#xD;
  Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health outcomes for cancer recurrence using PSA</measure>
      <time_frame>Baseline</time_frame>
      <description>Measured by Prostate specific antigen ( PSA )</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health outcomes for urinary function using IPSS</measure>
      <time_frame>Baseline</time_frame>
      <description>Measured using International Prostate symptom score (IPSS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health outcomes for sexual function using SHIM score</measure>
      <time_frame>Baseline</time_frame>
      <description>Measured using Sexual Health inventory for men (SHIM) score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health outcomes for cancer recurrence using PSA</measure>
      <time_frame>3-month post treatment decision</time_frame>
      <description>Measured by Prostate specific antigen ( PSA )</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health outcomes for urinary function</measure>
      <time_frame>3-month post treatment decision</time_frame>
      <description>Measured using International Prostate symptom score (IPSS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health outcomes for sexual function</measure>
      <time_frame>3-month post treatment decision</time_frame>
      <description>Measured using Sexual Health inventory for men (SHIM) score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health outcomes for cancer recurrence using PSA</measure>
      <time_frame>12-months post treatment decision</time_frame>
      <description>Measured by Prostate specific antigen ( PSA )</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health outcomes for urinary function</measure>
      <time_frame>12-months post treatment decision</time_frame>
      <description>Measured using International Prostate symptom score (IPSS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health outcomes for sexual function</measure>
      <time_frame>12-months post treatment decision</time_frame>
      <description>Measured using Sexual Health inventory for men (SHIM) score</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Prostate Carcinoma</condition>
    <arm_group>
      <arm_group_label>Arm 1 (AVCT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients participate in an adaptive virtual consultation on trial.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2 (non-AVCT)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients participate in a non-adaptive virtual consultation on trial.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 3 (information-only)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients receive information-only on trial.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health Education</intervention_name>
      <description>Participate in an adaptive virtual consultation</description>
      <arm_group_label>Arm 1 (AVCT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health Education</intervention_name>
      <description>Participate in a non-adaptive virtual consultation</description>
      <arm_group_label>Arm 2 (non-AVCT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Informational Intervention</intervention_name>
      <description>Given information-only</description>
      <arm_group_label>Arm 3 (information-only)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm 1 (AVCT)</arm_group_label>
      <arm_group_label>Arm 2 (non-AVCT)</arm_group_label>
      <arm_group_label>Arm 3 (information-only)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The participants in this study will be community dwelling, males with PC and their&#xD;
               healthcare advocate, if applicable&#xD;
  &#xD;
            -  Proficiency in English is required&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mental incompetency to participate in the study and/or no treatment option due to&#xD;
               other health reasons&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Male</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mitchell R Humphreys</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mayo Clinic in Arizona</name>
        <address>
          <city>Scottsdale</city>
          <state>Arizona</state>
          <zip>85259</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>
      <investigator>
        <last_name>Mitchell R. Humphreys, M.D.</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 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Mitchell Humphreys</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>Prostatic Neoplasms</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/NCT06016504
  org study id: 21-002955
  secondary id: NCI-2022-09812
  secondary id: 21-002955
  nct id: NCT06016504
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial aims to design and validate an adaptive virtual consultation tool (AVCT)
        for men with prostate cancer (PC). An AVCT utilizes health literacy assessments in
        combination with learning preferences and individual disease characteristics to provide
        focused and guided knowledge on PC tailored to the individual patient. Using an AVCT to
        enhance patient education may improve patient understanding and result in higher patient
        satisfaction with treatment decisions amongst men with PC.
  PRIMARY OBJECTIVES:
  
        I. To develop an adaptive virtual consultation tool for PC (AVCT):
  
        Ia. To incorporate and integrate the inputs from a diverse group of patients (including
        minorities), patient advocates, nursing, physicians and education experts in the design
        process for the adaptive consultation tool; Ib. Employ user centered iterative design
        approach to develop an adaptive learning tool on mobile devices that is tailored to
        individuals based on symptoms, health literacy, learning style, and disease specific
        characteristics.
  
        II. To assess the feasibility, acceptability and usability of AVCT:
  
        IIa. To validate the design approach and customization rules at the completion of the
        participatory design process using a convenience sample of subjects through assessment of
        system interaction logs and qualitative feedback from users on cognition, ease-of-use,
        usability and customization efficacy; IIb. To utilize the feasibility study results in (2a)
        to refine the interface, information presentation, and adaptive customization approach.
  
        III. To determine the efficacy of AVCT using a small-scale comparative study:
  
        IIIa. To design and execute a three arm comparative study consisting of adaptive virtual
        consultation, non-adaptive virtual consultation and standard-practice information-only
        control intervention and assess the comparative efficacy of the tool on the main outcome
        variable, satisfaction with health care episode; IIIb. To measure changes in other outcome
        variables at baseline, post-intervention, 3-month and 12-month duration; IIIc. To analyze the
        mediating influence of decision self-efficacy and a number of moderating factors including
        preference for decision-making participation and health literacy on outcome variables.
  
        OUTLINE: Patients are randomized to 1 of 3 arms.
  
        ARM 1: Patients participate in an adaptive virtual consultation on trial.
  
        ARM 2: Patients participate in a non-adaptive virtual consultation on trial.
  
        ARM 3: Patients receive information-only on trial.
  
        After completion of study intervention, patients are followed up at 3- and 12-months post
        treatment decision.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Patient satisfaction measured by post utilization surveys
  time frame: 3-month post treatment decision
  description: Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools.
  Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.
  measure: Patient satisfaction measured by post utilization surveys
  time frame: 12-month post treatment decision
  description: Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools.
  Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.
  measure: Health outcomes for cancer recurrence using PSA
  time frame: Baseline
  description: Measured by Prostate specific antigen ( PSA )
  measure: Health outcomes for urinary function using IPSS
  time frame: Baseline
  description: Measured using International Prostate symptom score (IPSS)
  measure: Health outcomes for sexual function using SHIM score
  time frame: Baseline
  description: Measured using Sexual Health inventory for men (SHIM) score
  measure: Health outcomes for cancer recurrence using PSA
  time frame: 3-month post treatment decision
  description: Measured by Prostate specific antigen ( PSA )
  measure: Health outcomes for urinary function
  time frame: 3-month post treatment decision
  description: Measured using International Prostate symptom score (IPSS)
  measure: Health outcomes for sexual function
  time frame: 3-month post treatment decision
  description: Measured using Sexual Health inventory for men (SHIM) score
  measure: Health outcomes for cancer recurrence using PSA
  time frame: 12-months post treatment decision
  description: Measured by Prostate specific antigen ( PSA )
  measure: Health outcomes for urinary function
  time frame: 12-months post treatment decision
  description: Measured using International Prostate symptom score (IPSS)
  measure: Health outcomes for sexual function
  time frame: 12-months post treatment decision
  description: Measured using Sexual Health inventory for men (SHIM) score
  arm group label: Arm 1 (AVCT)
  arm group type: Experimental
  description: Patients participate in an adaptive virtual consultation on trial.
  arm group label: Arm 2 (non-AVCT)
  arm group type: Active Comparator
  description: Patients participate in a non-adaptive virtual consultation on trial.
  arm group label: Arm 3 (information-only)
  arm group type: Active Comparator
  description: Patients receive information-only on trial.
  intervention type: Behavioral
  intervention name: Health Education
  description: Participate in an adaptive virtual consultation
  arm group label: Arm 1 (AVCT)
  intervention type: Behavioral
  intervention name: Health Education
  description: Participate in a non-adaptive virtual consultation
  arm group label: Arm 2 (non-AVCT)
  intervention type: Other
  intervention name: Informational Intervention
  description: Given information-only
  arm group label: Arm 3 (information-only)
  intervention type: Other
  intervention name: Survey Administration
  description: Ancillary studies
  arm group label: Arm 1 (AVCT)
  arm group label: Arm 2 (non-AVCT)
  arm group label: Arm 3 (information-only)
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Male
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Mitchell R Humphreys
  role: Principal Investigator
  affiliation: Mayo Clinic
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Mitchell Humphreys
  investigator title: Principal Investigator
  mesh term: Prostatic Neoplasms