Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03278197 |
Other study ID # |
14-40-19/11-intern-6745 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2015 |
Est. completion date |
February 2017 |
Study information
Verified date |
November 2020 |
Source |
Maastricht Radiation Oncology |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
Description:
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).