About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
SDM protocol
Other interventionCard news and Videos related to general knowledge and treatment of low-risk thyroid cancer
Treatment groups
Trial outcomes
Primary outcomes
Decision Conflict Scale: DCS
which assesses an individual's perception and understanding of decision-making by 16 items. The scale is 5-point Likert scale from 0 (Strongly Agree) to 4 (Strongly Disagree), and scores are calculated through a) summed, b) divided by 16, and c) multiplied by 25, and range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Secondary outcomes
Decision Regret Scale: DRS
measures distress and remorse after making a healthcare decision. Scale ranges from 1 (Strongly agree) to 5(Strongly Disagree). The final score, the items are summed and averaged. ranging from 0 (no regret) to 100 (high regret).
Shared Decision Making Questionnaire (SDM-Q-9)
a nine-item questionnaire assessing the quality of SDM from both patient and clinician perspectives. Scale ranges from 1(completely disagree) to 6(completely agree). Higher scores are indicative of more SDM.
Patients' Perceived involvement of Care Scale (PICS)
a 13-item questionnaire evaluating patient engagement in primary care \[12\]. It measures Clinician's information provision, patient's proactive information-seeking, and patient participation in treatment decisions (5-point Likert scale; 1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate lower clinician control and greater patient involvement in decision-making.
multifocal approach to sharing in shared decision making(Mappin'SDM)
that incorporates physician, patient, and observer perspectives during medical consultations. a 15-item tool adapted from the 12-item OPTION scale to evaluate observed patient involvement in decision-making \[13\]. Each item consists of behavioral and outcome components (a total of 30 items), rated by patients, clinicians, and observers (through real-time or via video review). Scale ranges from 0(not at all) to 5(absolutely true). High scores indicate high quality of decision-making communication across patient engagement.
Locations
Sponsors and contacts
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National Cancer Center, Korea
Lead sponsor
Seoul National University Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
SMG-SNU Boramae Medical Center
Collaborator
Nowon Eulji Medical Center
Collaborator
Hanyang University
Collaborator
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