<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/NCT03278197</url>
  </required_header>
  <id_info>
    <org_study_id>14-40-19/11-intern-6745</org_study_id>
    <nct_id>NCT03278197</nct_id>
  </id_info>
  <brief_title>Evaluation of a Web-based Decision Aid Tool for Prostate Cancer Patients</brief_title>
  <acronym>ProDecA</acronym>
  <official_title>Evaluating a Decision Aid in Clinical Practice for Patients With Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht Radiation Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zuyderland Medical Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VieCuri Medical Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laurentius Ziekenhuis Roermond</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St.Jans Gasthuis Weert</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht Radiation Oncology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients diagnosed with localized prostate cancer may be eligible for different treatment&#xD;
      options. MAASTRO Clinic (MAAStricht Radiation Oncology) developed a web-based decision aid&#xD;
      tool for these patients. The goal of the tool is to help patients to understand the&#xD;
      treatments, and empower the patients to participate in the decision making process. The aim&#xD;
      of this study is threefold:&#xD;
&#xD;
      (A) user-testing and validation of the tool, by using a systematically development process&#xD;
      compliant with the IPDAS (International Patients Decision Aids Standards) criteria (B)&#xD;
      establish the impact of the tool on the decision making process; (C) identify barriers and&#xD;
      facilitators for the implementation of shared decision making and the tool in clinical&#xD;
      practice.&#xD;
&#xD;
      The study covers 3 phases:&#xD;
&#xD;
        1. Development phase 1.1 Assess decisional needs of patients and clinicians. 1.2 Test&#xD;
           patients' and clinicians' comprehensibility, acceptability and usability on the&#xD;
           alpha-version of the tool. 1.3 Value clarification: Delphi study with former prostate&#xD;
           cancer patients to determine the most important patient preferences and value&#xD;
           clarification aspects the decision aid should include.&#xD;
&#xD;
        2. Implementation phase: Develop an implementation and dissemination plan for shared&#xD;
           decision-making which is based on the evaluation of barriers and facilitators for the&#xD;
           use of patient decision aid tools in clinical practice.&#xD;
&#xD;
        3. Evaluation phase: Establish the impact of on knowledge, decisional conflict and the&#xD;
           shared decision-making process, as well as the extent to which clinicians involve&#xD;
           patients in decision-making.&#xD;
&#xD;
      A mixed method will be used. It comprises structured interviews combined with think aloud and&#xD;
      questionnaires with stakeholders involved in the whole process of development, implementation&#xD;
      and evaluation (patients, urologists, radiotherapists, nurses, general practitioners, patient&#xD;
      organizations, and insurance companies).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer is the most common malignancy observed among men in industrialized countries,&#xD;
      with 1.11 million new cases diagnosed in 2012 . For patients with localized prostate cancer,&#xD;
      different treatment options are available; radical prostatectomy, external beam radiotherapy,&#xD;
      interstitial radiotherapy also called Brachytherapy (early-stage disease), and 'active&#xD;
      surveillance' (low risk patients). The optimal treatment for patients having localized&#xD;
      prostate cancer is not unambiguously proven. Different treatment options cause different side&#xD;
      effects that may impact the patients' health-related quality of life. The treatment of choice&#xD;
      depends on preferences and personal values. In these preference-sensitive choices it is&#xD;
      important to involve the patient in the decision-making process. In this process both the&#xD;
      practitioner and the patient exchange information and collaborate in the decision, the&#xD;
      physician knows more technical information about the disease, the treatment options and the&#xD;
      side effects, the patient knows how the treatment options correspond with his lifestyle,&#xD;
      values and preferences.&#xD;
&#xD;
      Patient Decision Aids (PDAs) are tools that can help patients to get involved in decision&#xD;
      making by clarifying treatment options, outcomes, and personal values. In the development&#xD;
      process of a decision aid it is mandatory to follow a systematic and iterative approach to:&#xD;
      (a) understand patient's decisional needs; (b) create prototypical tools; (c) evaluate these&#xD;
      prototypes with patients and clinicians, and (d) use these results to improve the tool.&#xD;
&#xD;
      Considering the International Patient Decision Aid Standards (http://ipdas.ohri.ca/), the&#xD;
      investigators designed an initial prototype, called Treatmentchoice&#xD;
      (http://www.treatmentchoice.info). These standards recommend assessing patients and doctors&#xD;
      views in decisional needs, use this information to develop an alpha version of the PDA and&#xD;
      validate the Treatmentchoice again with patients and doctors to create a beta version.&#xD;
&#xD;
      The aim of this project is user-testing the initial prototype of the Treatmentchoice. This&#xD;
      will allow the investigators to follow a systematic development process and to gain knowledge&#xD;
      on the validity of approach of the investigators. The project covers 4 activities:&#xD;
&#xD;
      ACTIVITY 1.1: ASSESS DECISIONAL NEEDS: Elicit patients' and clinicians' views on patient's&#xD;
      information, expectations, and needs on decision support. Conclusions and recommendations for&#xD;
      improvement of Treatmentchoice will be derived and the current prototype will be improved&#xD;
      creating an alpha prototype.&#xD;
&#xD;
      ACTIVITY 1.2: ALPHA-TESTING: Testing patients' and clinicians' comprehensibility,&#xD;
      acceptability and usability on the alpha prototype. A mixed method will be used; structured&#xD;
      interviews combined with think aloud (Ahmed, 2009) and questionnaires (Unified Theory of&#xD;
      Acceptance and Use of Technology (UTAUT) - Venkatesh et al.) with both patients and&#xD;
      clinicians (urologists, radiotherapists and general practitioners). Conclusions and&#xD;
      recommendations will be documented. Considering this assessment, the prototype will be&#xD;
      improved. Alpha testing will be repeated with this improved prototype using an iterative&#xD;
      process, until the tool is comprehensible, acceptable and usable for both patients and&#xD;
      physicians.&#xD;
&#xD;
      ACTIVITY 1.3: DELPHI STUDY: Gain an in-depth understanding of the information needs of&#xD;
      prostate cancer patients at each stage from diagnosis to treatment and post-treatment. The&#xD;
      purpose is to improve the contents of the decision aid so that it contains an accurate&#xD;
      representation of the factors that are most relevant to prostate cancer patients. First,&#xD;
      focus group interviews with former prostate cancer patients and patient organizations will be&#xD;
      carried out. The results will be analyzed and a list of factors will be generated. A Delphi&#xD;
      consensus process will be used to rank the relative importance of these factors and the tool&#xD;
      will be updated to give information that is most important for patients.&#xD;
&#xD;
      ACTIVITY 2: IMPACT STUDY (or beta testing): Evaluation of the impact of Treatmentchoice on&#xD;
      knowledge, decisional conflict and the shared decision making process, as well as the extent&#xD;
      to which clinicians involve patients in decision making. A variety of questionnaires will be&#xD;
      used to assess different outcome measures:&#xD;
&#xD;
        -  Age and educational level, home internet connection, and computer skills&#xD;
&#xD;
        -  Knowledge test will be assessed using 20 statements, which can be rated as &quot;true&quot;,&#xD;
           &quot;false&quot; or &quot;do not know&quot; .&#xD;
&#xD;
        -  Decisional conflict will be assessed using the Decisional Conflict Scale (DCS). This&#xD;
           16-item scale has five subscales: feeling informed, decisional uncertainty, clear&#xD;
           values, support, and quality of decisions. Each of these items is scored on a five-point&#xD;
           Likert scale from 1 (strongly agree) to 5 (strongly disagree).&#xD;
&#xD;
        -  Patient's desire to participate in medical decisions will be assessed using a 5-item&#xD;
           Control Preference Scale.&#xD;
&#xD;
        -  The Shared Decision Making (SDM) process will be assessed by the perceptions of&#xD;
           patients, using the SDM-Q9 instrument for patients. The instrument provides 9&#xD;
           statements, which can be rated on a six-point scale from 0 (completely disagree) to 5&#xD;
           (completely agree). (SDM-Q9, Rodenburg, 2015 /Dutch version).&#xD;
&#xD;
        -  The process of SDM will also be assessed by the perceptions of the physician (the&#xD;
           urologist or the RTO if the decision is made together with an RTO), using the SDM-Q9&#xD;
           instrument for professionals. The instrument provides 9 statements, also rated on a&#xD;
           six-point scale.&#xD;
&#xD;
      The patients will be asked to fill in the questionnaires at two time points: directly after&#xD;
      the decision making process and 3 months after the decision making process. Their physician&#xD;
      will be asked to fill in the questionnaire at one-time point, directly after the decision&#xD;
      making process.&#xD;
&#xD;
      ACTIVITY 3: IMPLEMENTATION: Identify key aspects on the implementation and dissemination for&#xD;
      shared decision-making in prostate cancer. Semi-structured interviews will be performed to&#xD;
      recognize barriers and facilitators for implementation in clinical practice, to develop&#xD;
      strategies for the implementation of decision aids and to facilitate optimal shared&#xD;
      decision-making which is tailored to the needs of the end-users (patients and doctors).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Patient's decisional needs to make a decision about their treatment</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Patients' decisional needs (development phase):semi-structured interviews with patients about their medical history, their experience with the treatment, the decision about their treatment, and what information the patients need to make an informed decision</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comprehensibility of the decision aid too</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Quantitative research using the Unified Theory of Acceptance and Use of Technology (UTAUT Venkatesh et al. 2013). This questionnaire. (5-Likert) measure how patients and clinicians perceived its utility, effectiveness and efficiency for shared decision-making, as well as their satisfaction with the decision aid.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usability of the decision aid too</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Quantitative research using a questionnaire based on the International Standard ISO-9242-11. This questionnaire (5-Likert) measure to what extent the decision aid is easy to use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decisional conflict (patients, evaluation phase)</measure>
    <time_frame>2 weeks after diagnosis</time_frame>
    <description>Decisional conflict will be assessed using the DCS (Decisional conflict scale): change in DCS between baseline group (usual care) and intervention group (use of the aid tool)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Control Preference Scale (patients; evaluation phase)</measure>
    <time_frame>2 weeks after diagnosis</time_frame>
    <description>Patient's preference to participate in medical decisions will be assessed using the 5-item Control Preference Scale (CPS):change in CPS between baseline group (usual care) and intervention group (use of the aid tool)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perception shared decision-making (patients; evaluation phase)</measure>
    <time_frame>2 weeks after diagnosis</time_frame>
    <description>Patient's perception of the shared decision-making process will be assessed using the (shared decision making) SDM-Q9 instrument for patients: change in SDM between baseline group (usual care) and the intervention group (use of the aid tool)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perception shared decision-making (doctors; evaluation phase)</measure>
    <time_frame>2 weeks after diagnosis</time_frame>
    <description>Doctor's perception of the shared decision-making process will be assessed using the SDM-Q9 instrument for professionals: change in SDM between baseline group (usual care) and the intervention group (use of the aid tool)]]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients' views on the current decision-making process</measure>
    <time_frame>upto 1 year</time_frame>
    <description>Patients' views on the current decision-making process (development phase)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' satisfaction with decision aid (Treatmentchoice)</measure>
    <time_frame>upto 1 year</time_frame>
    <description>Patients' satisfaction with decision aid (Treatmentchoice) (development phase)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' intention to use and recommend Treatmentchoice to others</measure>
    <time_frame>upto 1 year</time_frame>
    <description>Patients' intention to use and recommend Treatmentchoice to others (development phase)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insights into the value clarification process of prostate cancer patients</measure>
    <time_frame>an average of 2 year</time_frame>
    <description>Insights into the value clarification process of prostate cancer patients by questionnaires (development phase)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Barriers and facilitators for the implementation of Treatmentchoice in clinical practice</measure>
    <time_frame>an average of 2 years</time_frame>
    <description>Barriers and facilitators for the implementation of Treatmentchoice in clinical practice (implementation phase) will be assessed by questionnaires</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>1.Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients diagnosed with prostate cancer and ex-prostate cancer patients:&#xD;
Interviews with patients to define their decisional needs and to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.&#xD;
Navigating through the Treatmentchoice Decisional Tool and think aloud while running the tool&#xD;
Questionnaires</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2.Clinicians</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Radiotherapy-oncologists, Urologists, General practitioners, Nurses&#xD;
Interviews with patients to define their decisional needs and to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.&#xD;
Navigating through the Treatmentchoice Decisional Tool and think aloud while running the tool&#xD;
Questionnaires</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3.Other involved organizations</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient Organizations and insurance companies Interviews with stakeholders (patients, clinicians, nurses, GP's, patient organizations, insurance companies) to determine the barriers and facilitators to the implementation of shared decision making and the decision aid</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interviews</intervention_name>
    <description>Interviews with patients, physicians and general practitioners (GPs) to define patients' decisional needs.</description>
    <arm_group_label>1.Patients</arm_group_label>
    <arm_group_label>2.Clinicians</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatmentchoice Decisional Tool</intervention_name>
    <description>Patients and physicians navigate through Treatmentchoice Decisional Tool and think aloud while running the tool</description>
    <arm_group_label>1.Patients</arm_group_label>
    <arm_group_label>2.Clinicians</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Patients and physicians fill out questionnaires on the usual care, Delphi study</description>
    <arm_group_label>1.Patients</arm_group_label>
    <arm_group_label>2.Clinicians</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interviews with stakeholders</intervention_name>
    <description>Interviews with stakeholders (patients, clinicians, nurses, GP's, patient organizations, insurance companies) to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.</description>
    <arm_group_label>3.Other involved organizations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Patients diagnosed with localized prostate cancer. There are no criteria for treatment&#xD;
             type.&#xD;
&#xD;
               -  Inclusion criteria:&#xD;
&#xD;
                    -  Stage I-II primary prostate cancer&#xD;
&#xD;
                    -  Proficient in Dutch&#xD;
&#xD;
                    -  &gt; 18 years old&#xD;
&#xD;
               -  Exclusion criteria:&#xD;
&#xD;
                    -  Patients that do not have a treatment choice (due to contra-indications or&#xD;
                       other medical reasons)&#xD;
&#xD;
                    -  Patients with recurrent disease.&#xD;
&#xD;
             For alpha testing patients that already made their decision are selected. For each&#xD;
             treatment (external beam radiotherapy (RT), interstitial RT, surgery and active&#xD;
             surveillance) at least 10 patients will be included.&#xD;
&#xD;
             For beta testing patients that are facing their decision will be included. Aiming for&#xD;
             an effect size of 0.60 for a difference in mean total score on the Decisional Conflict&#xD;
             Scale, it would require 45 patients per group (pre and post intervention) to determine&#xD;
             this effect with alpha 0.05 and power 0.80.&#xD;
&#xD;
             For the Delphi study prostate cancer patients who already underwent treatment will be&#xD;
             included.&#xD;
&#xD;
          2. Clinicians:&#xD;
&#xD;
               -  Radiotherapy-oncologists&#xD;
&#xD;
               -  Urologists&#xD;
&#xD;
               -  General practitioners&#xD;
&#xD;
               -  Nurses.&#xD;
&#xD;
             For alpha testing at least 10 physicians are selected.&#xD;
&#xD;
             For beta testing at least 45 questionnaires are required.&#xD;
&#xD;
          3. Patient organizations and insurance companies will be interviewed to evaluate barriers&#xD;
             and facilitators for implementation in clinical practice. The study will focus on&#xD;
             their respective roles in the promotion of shared decision making: patient&#xD;
             organizations in raising awareness among patients and insurance companies in providing&#xD;
             incentives for the use of decision aids in clinical practice.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Lambin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastro Clinic, The Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastro Clinic</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 ET</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>February 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>November 27, 2020</last_update_submitted>
  <last_update_submitted_qc>November 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  </patient_data>
  <!-- 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/NCT03278197
org study id: 14-40-19/11-intern-6745
nct id: NCT03278197
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Patients diagnosed with localized prostate cancer may be eligible for different treatment
      options. MAASTRO Clinic (MAAStricht Radiation Oncology) developed a web-based decision aid
      tool for these patients. The goal of the tool is to help patients to understand the
      treatments, and empower the patients to participate in the decision making process. The aim
      of this study is threefold:

      (A) user-testing and validation of the tool, by using a systematically development process
      compliant with the IPDAS (International Patients Decision Aids Standards) criteria (B)
      establish the impact of the tool on the decision making process; (C) identify barriers and
      facilitators for the implementation of shared decision making and the tool in clinical
      practice.

      The study covers 3 phases:

        1. Development phase 1.1 Assess decisional needs of patients and clinicians. 1.2 Test
           patients' and clinicians' comprehensibility, acceptability and usability on the
           alpha-version of the tool. 1.3 Value clarification: Delphi study with former prostate
           cancer patients to determine the most important patient preferences and value
           clarification aspects the decision aid should include.

        2. Implementation phase: Develop an implementation and dissemination plan for shared
           decision-making which is based on the evaluation of barriers and facilitators for the
           use of patient decision aid tools in clinical practice.

        3. Evaluation phase: Establish the impact of on knowledge, decisional conflict and the
           shared decision-making process, as well as the extent to which clinicians involve
           patients in decision-making.

      A mixed method will be used. It comprises structured interviews combined with think aloud and
      questionnaires with stakeholders involved in the whole process of development, implementation
      and evaluation (patients, urologists, radiotherapists, nurses, general practitioners, patient
      organizations, and insurance companies).
Prostate cancer is the most common malignancy observed among men in industrialized countries,
      with 1.11 million new cases diagnosed in 2012 . For patients with localized prostate cancer,
      different treatment options are available; radical prostatectomy, external beam radiotherapy,
      interstitial radiotherapy also called Brachytherapy (early-stage disease), and 'active
      surveillance' (low risk patients). The optimal treatment for patients having localized
      prostate cancer is not unambiguously proven. Different treatment options cause different side
      effects that may impact the patients' health-related quality of life. The treatment of choice
      depends on preferences and personal values. In these preference-sensitive choices it is
      important to involve the patient in the decision-making process. In this process both the
      practitioner and the patient exchange information and collaborate in the decision, the
      physician knows more technical information about the disease, the treatment options and the
      side effects, the patient knows how the treatment options correspond with his lifestyle,
      values and preferences.

      Patient Decision Aids (PDAs) are tools that can help patients to get involved in decision
      making by clarifying treatment options, outcomes, and personal values. In the development
      process of a decision aid it is mandatory to follow a systematic and iterative approach to:
      (a) understand patient's decisional needs; (b) create prototypical tools; (c) evaluate these
      prototypes with patients and clinicians, and (d) use these results to improve the tool.

      Considering the International Patient Decision Aid Standards (http://ipdas.ohri.ca/), the
      investigators designed an initial prototype, called Treatmentchoice
      (http://www.treatmentchoice.info). These standards recommend assessing patients and doctors
      views in decisional needs, use this information to develop an alpha version of the PDA and
      validate the Treatmentchoice again with patients and doctors to create a beta version.

      The aim of this project is user-testing the initial prototype of the Treatmentchoice. This
      will allow the investigators to follow a systematic development process and to gain knowledge
      on the validity of approach of the investigators. The project covers 4 activities:

      ACTIVITY 1.1: ASSESS DECISIONAL NEEDS: Elicit patients' and clinicians' views on patient's
      information, expectations, and needs on decision support. Conclusions and recommendations for
      improvement of Treatmentchoice will be derived and the current prototype will be improved
      creating an alpha prototype.

      ACTIVITY 1.2: ALPHA-TESTING: Testing patients' and clinicians' comprehensibility,
      acceptability and usability on the alpha prototype. A mixed method will be used; structured
      interviews combined with think aloud (Ahmed, 2009) and questionnaires (Unified Theory of
      Acceptance and Use of Technology (UTAUT) - Venkatesh et al.) with both patients and
      clinicians (urologists, radiotherapists and general practitioners). Conclusions and
      recommendations will be documented. Considering this assessment, the prototype will be
      improved. Alpha testing will be repeated with this improved prototype using an iterative
      process, until the tool is comprehensible, acceptable and usable for both patients and
      physicians.

      ACTIVITY 1.3: DELPHI STUDY: Gain an in-depth understanding of the information needs of
      prostate cancer patients at each stage from diagnosis to treatment and post-treatment. The
      purpose is to improve the contents of the decision aid so that it contains an accurate
      representation of the factors that are most relevant to prostate cancer patients. First,
      focus group interviews with former prostate cancer patients and patient organizations will be
      carried out. The results will be analyzed and a list of factors will be generated. A Delphi
      consensus process will be used to rank the relative importance of these factors and the tool
      will be updated to give information that is most important for patients.

      ACTIVITY 2: IMPACT STUDY (or beta testing): Evaluation of the impact of Treatmentchoice on
      knowledge, decisional conflict and the shared decision making process, as well as the extent
      to which clinicians involve patients in decision making. A variety of questionnaires will be
      used to assess different outcome measures:

        -  Age and educational level, home internet connection, and computer skills

        -  Knowledge test will be assessed using 20 statements, which can be rated as "true",
           "false" or "do not know" .

        -  Decisional conflict will be assessed using the Decisional Conflict Scale (DCS). This
           16-item scale has five subscales: feeling informed, decisional uncertainty, clear
           values, support, and quality of decisions. Each of these items is scored on a five-point
           Likert scale from 1 (strongly agree) to 5 (strongly disagree).

        -  Patient's desire to participate in medical decisions will be assessed using a 5-item
           Control Preference Scale.

        -  The Shared Decision Making (SDM) process will be assessed by the perceptions of
           patients, using the SDM-Q9 instrument for patients. The instrument provides 9
           statements, which can be rated on a six-point scale from 0 (completely disagree) to 5
           (completely agree). (SDM-Q9, Rodenburg, 2015 /Dutch version).

        -  The process of SDM will also be assessed by the perceptions of the physician (the
           urologist or the RTO if the decision is made together with an RTO), using the SDM-Q9
           instrument for professionals. The instrument provides 9 statements, also rated on a
           six-point scale.

      The patients will be asked to fill in the questionnaires at two time points: directly after
      the decision making process and 3 months after the decision making process. Their physician
      will be asked to fill in the questionnaire at one-time point, directly after the decision
      making process.

      ACTIVITY 3: IMPLEMENTATION: Identify key aspects on the implementation and dissemination for
      shared decision-making in prostate cancer. Semi-structured interviews will be performed to
      recognize barriers and facilitators for implementation in clinical practice, to develop
      strategies for the implementation of decision aids and to facilitate optimal shared
      decision-making which is tailored to the needs of the end-users (patients and doctors).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient's decisional needs to make a decision about their treatment
time frame: up to 1 year
description: Patients' decisional needs (development phase):semi-structured interviews with patients about their medical history, their experience with the treatment, the decision about their treatment, and what information the patients need to make an informed decision
measure: Comprehensibility of the decision aid too
time frame: up to 1 year
description: Quantitative research using the Unified Theory of Acceptance and Use of Technology (UTAUT Venkatesh et al. 2013). This questionnaire. (5-Likert) measure how patients and clinicians perceived its utility, effectiveness and efficiency for shared decision-making, as well as their satisfaction with the decision aid.
measure: Usability of the decision aid too
time frame: up to 1 year
description: Quantitative research using a questionnaire based on the International Standard ISO-9242-11. This questionnaire (5-Likert) measure to what extent the decision aid is easy to use.
measure: Decisional conflict (patients, evaluation phase)
time frame: 2 weeks after diagnosis
description: Decisional conflict will be assessed using the DCS (Decisional conflict scale): change in DCS between baseline group (usual care) and intervention group (use of the aid tool)
measure: Control Preference Scale (patients; evaluation phase)
time frame: 2 weeks after diagnosis
description: Patient's preference to participate in medical decisions will be assessed using the 5-item Control Preference Scale (CPS):change in CPS between baseline group (usual care) and intervention group (use of the aid tool)
measure: Perception shared decision-making (patients; evaluation phase)
time frame: 2 weeks after diagnosis
description: Patient's perception of the shared decision-making process will be assessed using the (shared decision making) SDM-Q9 instrument for patients: change in SDM between baseline group (usual care) and the intervention group (use of the aid tool)
measure: Perception shared decision-making (doctors; evaluation phase)
time frame: 2 weeks after diagnosis
description: Doctor's perception of the shared decision-making process will be assessed using the SDM-Q9 instrument for professionals: change in SDM between baseline group (usual care) and the intervention group (use of the aid tool)]]
measure: Patients' views on the current decision-making process
time frame: upto 1 year
description: Patients' views on the current decision-making process (development phase)
measure: Patients' satisfaction with decision aid (Treatmentchoice)
time frame: upto 1 year
description: Patients' satisfaction with decision aid (Treatmentchoice) (development phase)
measure: Patients' intention to use and recommend Treatmentchoice to others
time frame: upto 1 year
description: Patients' intention to use and recommend Treatmentchoice to others (development phase)
measure: Insights into the value clarification process of prostate cancer patients
time frame: an average of 2 year
description: Insights into the value clarification process of prostate cancer patients by questionnaires (development phase)
measure: Barriers and facilitators for the implementation of Treatmentchoice in clinical practice
time frame: an average of 2 years
description: Barriers and facilitators for the implementation of Treatmentchoice in clinical practice (implementation phase) will be assessed by questionnaires
arm group label: 1.Patients
arm group type: Experimental
description: Patients diagnosed with prostate cancer and ex-prostate cancer patients:
Interviews with patients to define their decisional needs and to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.
Navigating through the Treatmentchoice Decisional Tool and think aloud while running the tool
Questionnaires
arm group label: 2.Clinicians
arm group type: Other
description: Radiotherapy-oncologists, Urologists, General practitioners, Nurses
Interviews with patients to define their decisional needs and to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.
Navigating through the Treatmentchoice Decisional Tool and think aloud while running the tool
Questionnaires
arm group label: 3.Other involved organizations
arm group type: Other
description: Patient Organizations and insurance companies Interviews with stakeholders (patients, clinicians, nurses, GP's, patient organizations, insurance companies) to determine the barriers and facilitators to the implementation of shared decision making and the decision aid
intervention type: Other
intervention name: Interviews
description: Interviews with patients, physicians and general practitioners (GPs) to define patients' decisional needs.
arm group label: 1.Patients
arm group label: 2.Clinicians
intervention type: Other
intervention name: Treatmentchoice Decisional Tool
description: Patients and physicians navigate through Treatmentchoice Decisional Tool and think aloud while running the tool
arm group label: 1.Patients
arm group label: 2.Clinicians
intervention type: Other
intervention name: Questionnaires
description: Patients and physicians fill out questionnaires on the usual care, Delphi study
arm group label: 1.Patients
arm group label: 2.Clinicians
intervention type: Other
intervention name: Interviews with stakeholders
description: Interviews with stakeholders (patients, clinicians, nurses, GP's, patient organizations, insurance companies) to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.
arm group label: 3.Other involved organizations
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe Lambin, MD,PhD
role: Principal Investigator
affiliation: Maastro Clinic, The Netherlands
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No