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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21139
Enrollment
128
Registered
2019-03-04
Start date
2019-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid cancer

Interventions

This proposal improves values deliberation in treatment choices through development, implementation and evaluation of a multifaceted intervention (COMBO), that includes a decision aid, a values clarif

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
Choice and decision making role Knowledge Evaluation of the decision Worries and trust Patient evaluation of SDM process Audio recording

Primary

MeasureTime frame
Quality of SDM, assessed from the audio-recording of the consultation.

Contacts

Public ContactRosalie Koot

Radboudumc

rosalie.koot@radboudumc.nl0651637081

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)