Focus on values to stimulate shared decisions in patients with thyroid cancer: A multifaceted COMmunication BOoster (COMBO)*
Phase 3
- Conditions
- Thyroid cancer1001471010014705
- Registration Number
- NL-OMON55767
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 128
Inclusion Criteria
Patients with primary and advanced thyroid cancer
Exclusion Criteria
Exclusion criteria are clinical exclusion criteria, lack of Dutch language
proficiency, and mental incompetence hampering the process of shared decision
making as judged by the physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome, SDM measure from the consultation<br /><br>Our primary outcome measure is the quality of SDM, assessed from the<br /><br>audio-recording of the consultation. These recordings are transcribed and<br /><br>scored on the 5-item Observer OPTION scale assessing to what extent physicians<br /><br>involves patients in decision making. Atlas.ti is used to code the transcripts.<br /><br>Coders will be trained by an experienced coder using the training module from<br /><br>the OPTION instrument. Each consultation is assessed by two coders to enhance<br /><br>accuracy and test reliability. Coders are blinded to the randomisation arm.<br /><br>Prior to coding, in the intervention group only, utterances identifying the<br /><br>intervention group will be removed by an independent third coder. Discrepant<br /><br>ratings are iteratively discussed and resolved by consensus.</p><br>
- Secondary Outcome Measures
Name Time Method