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Evaluation of a Web-based Decision Aid Tool for Prostate Cancer Patients (ProDecA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278197
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
Maastricht University Medical Center
Zuyderland Medical Centre
VieCuri Medical Centre
Laurentius Ziekenhuis Roermond
St.Jans Gasthuis Weert
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Interviews Other: Treatmentchoice Decisional Tool Other: Questionnaires Other: Interviews with stakeholders Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating a Decision Aid in Clinical Practice for Patients With Localized Prostate Cancer
Actual Study Start Date : January 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1.Patients

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
Other: Interviews
Interviews with patients, physicians and general practitioners (GPs) to define patients' decisional needs.

Other: Treatmentchoice Decisional Tool
Patients and physicians navigate through Treatmentchoice Decisional Tool and think aloud while running the tool

Other: Questionnaires
Patients and physicians fill out questionnaires on the usual care, Delphi study

2.Clinicians

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
Other: Interviews
Interviews with patients, physicians and general practitioners (GPs) to define patients' decisional needs.

Other: Treatmentchoice Decisional Tool
Patients and physicians navigate through Treatmentchoice Decisional Tool and think aloud while running the tool

Other: Questionnaires
Patients and physicians fill out questionnaires on the usual care, Delphi study

3.Other involved organizations
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
Other: 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.




Primary Outcome Measures :
  1. Patient's decisional needs to make a decision about their treatment [ Time Frame: up to 1 year ]
    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

  2. Comprehensibility of the decision aid too [ Time Frame: up to 1 year ]
    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.

  3. Usability of the decision aid too [ Time Frame: up to 1 year ]
    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.

  4. Decisional conflict (patients, evaluation phase) [ Time Frame: 2 weeks after diagnosis ]
    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)

  5. Control Preference Scale (patients; evaluation phase) [ Time Frame: 2 weeks after diagnosis ]
    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)

  6. Perception shared decision-making (patients; evaluation phase) [ Time Frame: 2 weeks after diagnosis ]
    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)

  7. Perception shared decision-making (doctors; evaluation phase) [ Time Frame: 2 weeks after diagnosis ]
    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)]]


Secondary Outcome Measures :
  1. Patients' views on the current decision-making process [ Time Frame: upto 1 year ]
    Patients' views on the current decision-making process (development phase)

  2. Patients' satisfaction with decision aid (Treatmentchoice) [ Time Frame: upto 1 year ]
    Patients' satisfaction with decision aid (Treatmentchoice) (development phase)

  3. Patients' intention to use and recommend Treatmentchoice to others [ Time Frame: upto 1 year ]
    Patients' intention to use and recommend Treatmentchoice to others (development phase)

  4. Insights into the value clarification process of prostate cancer patients [ Time Frame: an average of 2 year ]
    Insights into the value clarification process of prostate cancer patients by questionnaires (development phase)


Other Outcome Measures:
  1. Barriers and facilitators for the implementation of Treatmentchoice in clinical practice [ Time Frame: an average of 2 years ]
    Barriers and facilitators for the implementation of Treatmentchoice in clinical practice (implementation phase) will be assessed by questionnaires



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  1. Patients diagnosed with localized prostate cancer. There are no criteria for treatment type.

    • Inclusion criteria:

      • Stage I-II primary prostate cancer
      • Proficient in Dutch
      • > 18 years old
    • Exclusion criteria:

      • Patients that do not have a treatment choice (due to contra-indications or other medical reasons)
      • Patients with recurrent disease.

    For alpha testing patients that already made their decision are selected. For each treatment (external beam radiotherapy (RT), interstitial RT, surgery and active surveillance) at least 10 patients will be included.

    For beta testing patients that are facing their decision will be included. Aiming for an effect size of 0.60 for a difference in mean total score on the Decisional Conflict Scale, it would require 45 patients per group (pre and post intervention) to determine this effect with alpha 0.05 and power 0.80.

    For the Delphi study prostate cancer patients who already underwent treatment will be included.

  2. Clinicians:

    • Radiotherapy-oncologists
    • Urologists
    • General practitioners
    • Nurses.

    For alpha testing at least 10 physicians are selected.

    For beta testing at least 45 questionnaires are required.

  3. Patient organizations and insurance companies will be interviewed to evaluate barriers and facilitators for implementation in clinical practice. The study will focus on their respective roles in the promotion of shared decision making: patient organizations in raising awareness among patients and insurance companies in providing incentives for the use of decision aids in clinical practice.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278197


Contacts
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Contact: Ben Vanneste, MD +31 88 44 55 666 ben.vanneste@maastro.nl

Locations
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Netherlands
Maastro Clinic Recruiting
Maastricht, Netherlands, 6229 ET
Contact: Ben Vanneste, MD    088-4455666    ben.vanneste@maastro.nl   
Sub-Investigator: Ben Vanneste, MD         
Principal Investigator: Philippe Lambin, MD, PhD         
Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University Medical Center
Zuyderland Medical Centre
VieCuri Medical Centre
Laurentius Ziekenhuis Roermond
St.Jans Gasthuis Weert
Investigators
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Principal Investigator: Philippe Lambin, MD,PhD Maastro Clinic, The Netherlands
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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT03278197    
Other Study ID Numbers: 14-40-19/11-intern-6745
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases