Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer (MAeSTro-SDM)

Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer: a Multicenter Cluster-Randomized Controlled 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Papillary Thyroid Carcinoma; Thyroid Cancer
• Intervention / Treatment: Other: SDM protocol

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 Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eun Kyung Lee; Phone Number: +82-31-920-1743; Email: eklee@ncc.re.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SDM Group (Shared Decision-Making Group; Intervention Group); Patients will receive detailed information, including an information leaflet about treatment options.; Clinicians will guide patients through a structured SDM protocol before finalizing the treatment decision.	Other: SDM protocol; Card news and Videos related to general knowledge and treatment of low-risk thyroid cancer
No Intervention: SC Group (Standard Care Group; Control Group); - Patients will receive standard medical care following current clinical practices without the SDM protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)	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
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

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Collaborators: Seoul National University Hospital; Seoul National University Bundang Hospital; Hanyang University; SMG-SNU Boramae Medical Center; Nowon Eulji Medical Center
• Investigators: Principal Investigator: Young Joo Park, Seoul National University Hospital; Principal Investigator: Eun Kyung Lee, National Cancer Center; Principal Investigator: Min Joo Kim, 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

Study record dates

Study Major Dates

• Study Start (Estimated): May 12, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Active surveillance; Shared decision making
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Adenocarcinoma, Papillary; Thyroid Cancer, Papillary; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: 2025-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No