<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/NCT03292341</url>
  </required_header>
  <id_info>
    <org_study_id>15-28-03/06</org_study_id>
    <nct_id>NCT03292341</nct_id>
  </id_info>
  <brief_title>Evaluation of a Web-based Decision Aid Tool for Larynx Cancer (T3/T4) Patients.</brief_title>
  <acronym>LaDecA</acronym>
  <official_title>Evaluating a Decision Aid in Clinical Practice for Patients With T3/T4 Laryngeal 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>The Netherlands Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht Radiation Oncology</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>
      Patients diagnosed with T3/T4 laryngeal cancer in general have several treatment options&#xD;
      available, including total laryngectomy and/or (chemo-) radition. In order to help these&#xD;
      patients in the decision making process, MAASTRO CLINIC designed and developed a web-based&#xD;
      decision aid tool (Treatmentchoice). The aim of this study is twofold: user-testing&#xD;
      Treatmentchoice using a systematically development process and establish the impact of&#xD;
      Treatmentchoice on the decision making process.&#xD;
&#xD;
      The study covers 4 chronological activities: 1. assess decisional needs of patients and&#xD;
      clinicians, 2. testing patients' and clinicians comprehensibility, acceptability and&#xD;
      usability on the alpha-version of the tool, 3. establish the impact of Treatmentchoice on&#xD;
      knowledge, decisional conflict and the shared decision making process, as well as the extent&#xD;
      clinicians involve patients in decision making and 4. development of an implementation and&#xD;
      dissemination plan for shared decision making which is based on the evaluation of barriers&#xD;
      and facilitators for the use of patients decision aid tools in clinical practice.&#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 (patients, medical doctors,&#xD;
      nurses, general practitioners, patient organizations, and insurance companies).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laryngeal cancer is the second most common head and neck cancer. Each year about 700 people&#xD;
      are diagnosed with larynxcarcinoma in the Netherlands (Van Dijk et.al. 2013).&#xD;
&#xD;
      For patients with laryngeal cancer, various treatment options are available, including&#xD;
      surgery, radiotherapy, chemotherapy and endoscopic (laser) treatment. Each option has its own&#xD;
      benefits and side effects. The optimal treatment for patients having stage 3 or 4 laryngeal&#xD;
      cancer is not unambiguously proven. Different treatment options cause different side effects&#xD;
      that may impact the patients' health-related quality of life. The treatment of choice depends&#xD;
      on preferences and personal values. In these preference-sensitive choices it is important to&#xD;
      involve the patient in the decision-making process. In this process both the practitioner and&#xD;
      the patient exchange information and collaborate in the decision, the physician knows more&#xD;
      technical information about the disease, the treatment options and the side effects, the&#xD;
      patient knows how the treatment options correspond with his lifestyle, values and preferences&#xD;
      (Frosch DL and Kaplan RM, 1999; O'Connor AM, et.al. 2003; O'Connor AM, et.al., 2004).&#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/), we&#xD;
      designed an initial prototype, called Treatmentchoice (http://www.treatmentchoice.info).&#xD;
      These standards recommend assessing patients and doctors views in decisional needs, use this&#xD;
      information to develop an alpha version of the PDA and validate it again with patients and&#xD;
      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 us to follow a systematically development process and to gain knowledge on the&#xD;
      validity of our approach. The project covers 4 chronological activities:&#xD;
&#xD;
      ACTIVITY 1: ASSES 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 2: ALPHA-TESTING: Testing patients' and clinicians comprehensibility, acceptability&#xD;
      and usability on the alpha-version. A mixed method will be used; structured interviews&#xD;
      combined with think aloud (Ahmed, 2009) and questionnaires (Unified Theory of Acceptance and&#xD;
      Use of Technology (UTAUT) - Venkatesh et al.2012) with both patients and clinicians (head and&#xD;
      neck surgeon,medical oncologists an radiation oncologists). Conclusions and recommendations&#xD;
      will be documented. Considering this assessment, the prototype will be improved. Alpha&#xD;
      testing will be repeated with this improved prototype using an iterative process, until the&#xD;
      tool is comprehensible, acceptable and usable for both patients and physicians. A second&#xD;
      assessment will be performed with a beta prototype.&#xD;
&#xD;
      ACTIVITY 3: BETA-TESTING: Establish the impact of Treatmentchoice on knowledge, decisional&#xD;
      conflict and the shared decision making process, as well as the extent clinicians involve&#xD;
      patients in decision making. The study composes the evaluation of the impact of the&#xD;
      Treatmentchoice. A variety of questionnaires will be used to assess different outcome&#xD;
      measures:&#xD;
&#xD;
        -  Age and educational level, home situation with regard to internet connection.&#xD;
&#xD;
        -  Knowledge test will be assessed using 20 statements, which can be rated as &quot;true&quot;, &quot;not&#xD;
           true&quot; or &quot;do not know&quot; (Savelberg, 2015).&#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) (DCS, O'Connor AM, 2010).&#xD;
&#xD;
        -  Patient's desire to participate in medical decisions will be assessed using a 5-item&#xD;
           Control Preference Scale (Degner 1997).&#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;
           oncologist or the radiotherapist if the decision is made together with the&#xD;
           radiotherapist), using the SDM-Q9 instrument for professionals. The instrument provides&#xD;
           9 statements, also rated on a six-point scale (SDM-Q9,Rodenburg,2015/Dutch version).&#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 1 time point, directly after the decision&#xD;
      making process.&#xD;
&#xD;
      ACTIVITY 4: IMPLEMENTATION: Develop an implementation and dissemination plan for shared&#xD;
      decision making in prostate cancer. Questionnaires and qualitative interviews will be&#xD;
      performed to evaluate barriers and facilitators for implementation in clinical practice, to&#xD;
      develop strategies for the implementation of the decision aid and facilitate optimal shared&#xD;
      decision making, tailored to the barriers and needs of the end-users. Based on the results,&#xD;
      an implementation plan will be written&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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</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>an average of 2 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">9</enrollment>
  <condition>Larynx Cancer</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients diagnosed with larynx cancer and ex-larynx 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>Clinicians</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2.Clinicians Radiotherapy-oncologists, ENT(Ear-Nose-Throat)-specialists, 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>Other involved organizations</arm_group_label>
    <arm_group_type>Experimental</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>Clinicians</arm_group_label>
    <arm_group_label>Patients</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>Clinicians</arm_group_label>
    <arm_group_label>Patients</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>Clinicians</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interviews with stakeholders</intervention_name>
    <description>Interviews with stakeholders 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>Other involved organizations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Larynx cancer patients&#xD;
&#xD;
             Inclusion Criteria:&#xD;
&#xD;
               -  Larynx cancer: T3 anyN M0, T4 anyN M0&#xD;
&#xD;
               -  Proficient in Dutch&#xD;
&#xD;
               -  minimal 18 years old&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
               -  Patients that do not have a treatment choice (due to contra-indications or other&#xD;
                  medical reasons)&#xD;
&#xD;
               -  patients with recurrent disease&#xD;
&#xD;
             For alpha testing patients that already made there decision are selected. For each&#xD;
             treatment option (external beam RT, surgery and chemoradiation) at least 10 patients&#xD;
             will be included. For beta testing patients that are facing their decision will be&#xD;
             included. Aiming for an effect size of 0.60 for a difference in mean total score on&#xD;
             the Decisional Conflict Scale, it would require 45 patients per hospital (pre and post&#xD;
             intervention) to determine this effect with alpha 0.05 and power 0.80.&#xD;
&#xD;
          2. Physicians&#xD;
&#xD;
               -  Radiotherapy-oncologists&#xD;
&#xD;
               -  Oncologists&#xD;
&#xD;
               -  General practitioners&#xD;
&#xD;
               -  Nurses For alpha testing at least 10 physicians are selected. For beta testing at&#xD;
                  least 45 questionnaires are required.&#xD;
&#xD;
          3. Patient organizations and insurance companies Besides patients and physicians, patient&#xD;
             organizations and insurance companies will be involved to evaluate barriers and&#xD;
             facilitators for implementation in clinical practice.&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Frank Hoebers, 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>6229ET</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 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>Laryngeal 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/NCT03292341
org study id: 15-28-03/06
nct id: NCT03292341
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients diagnosed with T3/T4 laryngeal cancer in general have several treatment options
      available, including total laryngectomy and/or (chemo-) radition. In order to help these
      patients in the decision making process, MAASTRO CLINIC designed and developed a web-based
      decision aid tool (Treatmentchoice). The aim of this study is twofold: user-testing
      Treatmentchoice using a systematically development process and establish the impact of
      Treatmentchoice on the decision making process.

      The study covers 4 chronological activities: 1. assess decisional needs of patients and
      clinicians, 2. testing patients' and clinicians comprehensibility, acceptability and
      usability on the alpha-version of the tool, 3. establish the impact of Treatmentchoice on
      knowledge, decisional conflict and the shared decision making process, as well as the extent
      clinicians involve patients in decision making and 4. development of an implementation and
      dissemination plan for shared decision making which is based on the evaluation of barriers
      and facilitators for the use of patients decision aid tools in clinical practice.

      A mixed method will be used. It comprises structured interviews combined with think aloud and
      questionnaires with stakeholders involved in the whole process (patients, medical doctors,
      nurses, general practitioners, patient organizations, and insurance companies).
Laryngeal cancer is the second most common head and neck cancer. Each year about 700 people
      are diagnosed with larynxcarcinoma in the Netherlands (Van Dijk et.al. 2013).

      For patients with laryngeal cancer, various treatment options are available, including
      surgery, radiotherapy, chemotherapy and endoscopic (laser) treatment. Each option has its own
      benefits and side effects. The optimal treatment for patients having stage 3 or 4 laryngeal
      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
      (Frosch DL and Kaplan RM, 1999; O'Connor AM, et.al. 2003; O'Connor AM, et.al., 2004).

      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/), we
      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 it 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 us to follow a systematically development process and to gain knowledge on the
      validity of our approach. The project covers 4 chronological activities:

      ACTIVITY 1: ASSES 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 2: ALPHA-TESTING: Testing patients' and clinicians comprehensibility, acceptability
      and usability on the alpha-version. 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.2012) with both patients and clinicians (head and
      neck surgeon,medical oncologists an radiation oncologists). 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. A second
      assessment will be performed with a beta prototype.

      ACTIVITY 3: BETA-TESTING: Establish the impact of Treatmentchoice on knowledge, decisional
      conflict and the shared decision making process, as well as the extent clinicians involve
      patients in decision making. The study composes the evaluation of the impact of the
      Treatmentchoice. A variety of questionnaires will be used to assess different outcome
      measures:

        -  Age and educational level, home situation with regard to internet connection.

        -  Knowledge test will be assessed using 20 statements, which can be rated as "true", "not
           true" or "do not know" (Savelberg, 2015).

        -  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) (DCS, O'Connor AM, 2010).

        -  Patient's desire to participate in medical decisions will be assessed using a 5-item
           Control Preference Scale (Degner 1997).

        -  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
           oncologist or the radiotherapist if the decision is made together with the
           radiotherapist), using the SDM-Q9 instrument for professionals. The instrument provides
           9 statements, also rated on a six-point scale (SDM-Q9,Rodenburg,2015/Dutch version).

      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 1 time point, directly after the decision
      making process.

      ACTIVITY 4: IMPLEMENTATION: Develop an implementation and dissemination plan for shared
      decision making in prostate cancer. Questionnaires and qualitative interviews will be
      performed to evaluate barriers and facilitators for implementation in clinical practice, to
      develop strategies for the implementation of the decision aid and facilitate optimal shared
      decision making, tailored to the barriers and needs of the end-users. Based on the results,
      an implementation plan will be written
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
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: an average of 2 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: Patients
arm group type: Experimental
description: Patients diagnosed with larynx cancer and ex-larynx 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: Clinicians
arm group type: Experimental
description: 2.Clinicians Radiotherapy-oncologists, ENT(Ear-Nose-Throat)-specialists, 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: Other involved organizations
arm group type: Experimental
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: Clinicians
arm group label: Patients
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: Clinicians
arm group label: Patients
intervention type: Other
intervention name: Questionnaires
description: Patients and physicians fill out questionnaires on the usual care, Delphi study
arm group label: Clinicians
arm group label: Patients
intervention type: Other
intervention name: Interviews with stakeholders
description: Interviews with stakeholders 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: Other involved organizations
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frank Hoebers, MD,PhD
role: Principal Investigator
affiliation: Maastro Clinic, The Netherlands
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Laryngeal Neoplasms
sharing ipd: No