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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Center, Korea

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • SDM protocol

    Other intervention

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

Treatment groups

310 Participants
are divided into 2 treatment groups
Group A: SDM Group (Shared Decision-Making Group; Intervention Group)Experimental treatment 1 intervention
Group B: SC Group (Standard Care Group; Control Group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
at enrollment

Secondary outcomes

1

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).

Time frame
at 6month, 12month after enrollment
2

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.

Time frame
at enrollment, and 6month, 12month after enrollment
3

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.

Time frame
at enrollment, and 6month, 12month after enrollment
4

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.

Time frame
at enrollment, and 6month, 12month after enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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