Evaluation of a Web-based Decision Aid Tool for Prostate Cancer Patients
NCT03278197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2020-11-30
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).
Conditions
Interventions
- 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
- 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.
Sponsors & Collaborators
-
Maastricht University Medical Center
collaborator OTHER -
Zuyderland Medical Centre
collaborator OTHER -
VieCuri Medical Centre
collaborator OTHER -
Laurentius Ziekenhuis Roermond
collaborator UNKNOWN -
St.Jans Gasthuis Weert
collaborator UNKNOWN -
Maastricht Radiation Oncology
lead OTHER
Principal Investigators
-
Philippe Lambin, MD,PhD · Maastro Clinic, The Netherlands
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2016-02-29
- Completion
- 2017-02-28
Countries
- Netherlands
Study Locations
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