Status:
COMPLETED
Evaluation of a Web-based Decision Aid Tool for Prostate Cancer Patients
Lead Sponsor:
Maastricht Radiation Oncology
Collaborating Sponsors:
Maastricht University Medical Center
Zuyderland Medical Centre
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 pati...
Detailed 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 tre...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03278197
Start Date
January 1 2015
End Date
February 1 2017
Last Update
November 30 2020
Active Locations (1)
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1
Maastro Clinic
Maastricht, Netherlands, 6229 ET