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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278197 on ClinicalTrials.gov