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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| SMG-SNU Boramae Medical Center | OTHER |
| Nowon Eulji Medical Center |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDM Group (Shared Decision-Making Group; Intervention Group) | Experimental |
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| SC Group (Standard Care Group; Control Group) | No Intervention | - Patients will receive standard medical care following current clinical practices without the SDM protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDM protocol | Other | Card news and Videos related to general knowledge and treatment of low-risk thyroid cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at 6month, 12month after enrollment |
| Shared Decision Making Questionnaire (SDM-Q-9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Kyung Lee | Contact | +82-31-920-1743 | eklee@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Young Joo Park | Seoul National University Hospital | Principal Investigator |
| Eun Kyung Lee | National Cancer Center | Principal Investigator |
| Min Joo Kim |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41589080 | Derived | Lee EK, Kim MJ, Hwangbo Y, Moon JH, Cho SW, Chai YJ, Choi JY, Jung YS, Lee KE, Chung EJ, Kim K, Kim SJ, Kim W, Kim YH, Lee YK, Jang J, Song YS, Yi KH, Yu HW, Moon S, Jung KY, Kim HJ, Ryu CH, Ryu J, Seok J, Kang SH, Lee S, Chu AJ, Lee CY, Lee JY, Lim H, Kim JH, Park SK, Park YJ. Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer: Protocol of a Multicenter Cluster-Randomized Trial (MAeSTro-SDM). J Korean Med Sci. 2026 Jan 26;41(4):e58. doi: 10.3346/jkms.2026.41.e58. |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| OTHER |
| Hanyang University | OTHER |
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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. |
| at enrollment, and 6month, 12month after enrollment |
| 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. | at enrollment, and 6month, 12month after enrollment |
| 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. | at enrollment, and 6month, 12month after enrollment |
| Comparison of Quality of Life between the shared decision group and standard care group | 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. | at enrollment, and 6month, 12month after enrollment |
| Hospital Anxiety and Depression | 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. | at enrollment, and 6month, 12month after enrollment |
| Seoul National University Bundang Hospital |
| Principal Investigator |
| Young Shin Song | SMC-SNU Boramae Medical Center | Principal Investigator |
| Kyong Yeun Jung | Nowon Eulji Medical Center | Principal Investigator |
| Shin Je Moon | Hanyang University | Principal Investigator |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |