Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2027-12-31

Brief Summary

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This study is a multicenter cluster-randomized controlled trial conducted in Korea. A parallel, two-group cluster-randomized design will be used to test whether the Shared decision-making Group (SDM; intervention) is different from the Standard Care Group (SC; control).

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Detailed Description

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The primary objective of this clinical trial is to evaluate whether the group provided with a decision support tool for treatment planning (Intervention; SDM group) demonstrates improved satisfaction with the decision-making process compared to the group receiving standard care (Control; SC group) among patients diagnosed with low-risk thyroid cancer who need to determine their treatment plan.

The data are collected from patients who are diagnosed with low-risk PTC and Twenty doctors with various experience of AS will participate in the study.

Conditions

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Thyroid Cancer Papillary Thyroid Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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SDM Group (Shared Decision-Making Group; Intervention Group)

* Patients will receive detailed information, including an information leaflet about treatment options.
* Clinicians will guide patients through a structured SDM protocol before finalizing the treatment decision.

Group Type EXPERIMENTAL

SDM protocol

Intervention Type OTHER

Card news and Videos related to general knowledge and treatment of low-risk thyroid cancer

SC Group (Standard Care Group; Control Group)

\- Patients will receive standard medical care following current clinical practices without the SDM protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SDM protocol

Card news and Videos related to general knowledge and treatment of low-risk thyroid cancer

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 years or older with a thyroid nodule of 1.0 cm or less confirmed as Bethesda category V (suspicious for PTC) or VI (PTC) based on cytopathological examination, or Bethesda category III (atypia of undetermined significance) with a confirmed BRAF V600E mutation.
* Patients with no evidence of distant metastasis, cervical lymph node metastasis, recurrent laryngeal nerve invasion, or tracheal invasion. Additionally, no evidence of extrathyroidal extension (ETE) should be present, and the tumor must not belong to high-risk subtypes of PTC (e.g., diffuse sclerosing, columnar cell, or solid subtype).

Exclusion Criteria

* Patients who cannot undergo regular follow-up or are expected to have difficulties with follow-up.
* Patients with indeterminate or benign findings on thyroid biopsy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No