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

Not Applicable

Not yet recruiting

• Conditions: Thyroid Cancer; Papillary Thyroid Carcinoma

• Registration Number: NCT06730893
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-27
• Last Update Posted: 2025-04-30
• Study Start: 2025-05-12
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 310

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decision Conflict Scale: DCS	at enrollment	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 Outcome Measures

Name	Time	Method
Decision Regret Scale: DRS	at 6month, 12month after enrollment	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)	at enrollment, and 6month, 12month after enrollment	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)	at enrollment, and 6month, 12month after enrollment	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.
Comparison of Quality of Life between the shared decision group and standard care group	at enrollment, and 6month, 12month after enrollment	The Quality of Life - Thyroid (QOL-Thyroid) questionnaire was 30 items. These are assigned to four scales, each reflecting an aspect of QoL. Physical well-being is measured with two items and 13 questions, psychological well-being with 13 items and 22 questions, social concerns with eight items and 14 questions, and spiritual well-being with seven items and questions. Response options range from '0 = worst outcome' to '10 = best outcome' on an ordinal 11-point scale.
multifocal approach to sharing in shared decision making(Mappin'SDM)	at enrollment, and 6month, 12month after enrollment	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.
Hospital Anxiety and Depression	at enrollment, and 6month, 12month after enrollment	a 14-item tool (7 for anxiety, 7 for depression), developed to measure hospital patients' levels of anxiety and depression. Each item is rated on a 0-3 scale, with total scores ranging from 0 to 21 per subscale. A cutoff score of 8 or higher indicates clinically significant symptoms, based on Korean validation studies.