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Focus on values to stimulate shared decisions in patients with thyroid cancer: A multifacetedCOMmunication BOoster (COMBO)

Conditions
Thyroid cancer
Registration Number
NL-OMON21139
Lead Sponsor
Radboudumc
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
128
Inclusion Criteria

Total thyroidectomy vs hemithyroidectomy:
-patients with nodules >1 cm and <4 cm, with cytology result suspicious or malignant (Bethesda 5 or 6) with no clinical or radiological evidence of pathological lymph nodes and/or distant metastases before the primary (diagnostic) surgery
-patients with histologically (after diagnostic hemithyroidectomy) proven TC but are defined as low-risk according to the ATA
classification(97,98) -patients with multifocal TC
-patients with incomplete resection of the primary tumor
-patients with ATA defined intermediate risk or high risk

No treatment with RAI vs. treatment with RAI:
-patients with ATA defined low-risk (98) and patients with multifocal papillary TC in the absence of other adverse features.

Active surveillance vs. systemic treatment:
-patients with asymptomatic or mildly symptomatic RAI-refractory (slowly) progressive metastatic disease

Exclusion Criteria

Total thyroidectomy vs hemithyroidectomy:
-patients with multifocal TC
-patients with incomplete resection of the primary tumor
-patients with ATA defined intermediate risk or high risk

No treatment with RAI vs. treatment with RAI:
-patients with ATA defined intermediate risk or high risk

Active surveillance vs. systemic treatment:
-patients with coexisting conditions that do not allow prescription of TKI’s

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Quality of SDM, assessed from the audio-recording of the consultation.
Secondary Outcome Measures
NameTimeMethod
Choice and decision making role<br>Knowledge<br>Evaluation of the decision<br>Worries and trust<br>Patient evaluation of SDM process<br>Audio recording
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