Clinical trial NCT06730893: Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer
Official title: Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer: a Multicenter Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyroid Cancer
Papillary Thyroid Carcinoma
Keywords: Active surveillance
Shared decision making
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Seoul National University Hospital
name: Seoul National University Bundang Hospital
name: SMG-SNU Boramae Medical Center
name: Nowon Eulji Medical Center
name: Hanyang University
First posted: 2024-12-12
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decision Conflict Scale: DCS
timeFrame: at enrollment
Secondary outcomes:
measure: Decision Regret Scale: DRS
timeFrame: at 6month, 12month after enrollment
measure: Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: at enrollment, and 6month, 12month after enrollment
measure: Patients' Perceived involvement of Care Scale (PICS)
timeFrame: at enrollment, and 6month, 12month after enrollment
measure: multifocal approach to sharing in shared decision making(Mappin'SDM)
timeFrame: at enrollment, and 6month, 12month after enrollment
measure: Comparison of Quality of Life between the shared decision group and standard care group
timeFrame: at enrollment, and 6month, 12month after enrollment
measure: Hospital Anxiety and Depression
timeFrame: at enrollment, and 6month, 12month after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Young Joo Park
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Center
name: Eun Kyung Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Min Joo Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: SMC-SNU Boramae Medical Center
name: Young Shin Song
role: PRINCIPAL_INVESTIGATOR
affiliation: Nowon Eulji Medical Center
name: Kyong Yeun Jung
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Shin Je Moon
role: PRINCIPAL_INVESTIGATOR
References: