Status:
COMPLETED
Evaluation of a Web-based Decision Aid Tool for Larynx Cancer (T3/T4) Patients.
Lead Sponsor:
Maastricht Radiation Oncology
Collaborating Sponsors:
Maastricht University Medical Center
The Netherlands Cancer Institute
Conditions:
Larynx Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients diagnosed with T3/T4 laryngeal cancer in general have several treatment options available, including total laryngectomy and/or (chemo-) radition. In order to help these patients in the decisi...
Detailed Description
Laryngeal cancer is the second most common head and neck cancer. Each year about 700 people are diagnosed with larynxcarcinoma in the Netherlands (Van Dijk et.al. 2013). For patients with laryngeal c...
Eligibility Criteria
Inclusion
- Larynx cancer patients
- Larynx cancer: T3 anyN M0, T4 anyN M0
- Proficient in Dutch
- minimal 18 years old
Exclusion
- 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 there decision are selected. For each treatment option (external beam RT, surgery and chemoradiation) 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 hospital (pre and post intervention) to determine this effect with alpha 0.05 and power 0.80.
- Physicians
- Radiotherapy-oncologists
- Oncologists
- 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 Besides patients and physicians, patient organizations and insurance companies will be involved to evaluate barriers and facilitators for implementation in clinical practice.
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03292341
Start Date
September 1 2015
End Date
December 31 2016
Last Update
November 30 2020
Active Locations (1)
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1
MAASTRO Clinic
Maastricht, Netherlands, 6229ET