Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT06730893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2024-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D000231', 'term': 'Adenocarcinoma, Papillary'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 310}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-27', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decision Conflict Scale: DCS', 'timeFrame': 'at enrollment', 'description': "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)."}], 'secondaryOutcomes': [{'measure': 'Decision Regret Scale: DRS', 'timeFrame': 'at 6month, 12month after enrollment', 'description': '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).'}, {'measure': 'Shared Decision Making Questionnaire (SDM-Q-9)', 'timeFrame': 'at enrollment, and 6month, 12month after enrollment', 'description': '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.'}, {'measure': "Patients' Perceived involvement of Care Scale (PICS)", 'timeFrame': 'at enrollment, and 6month, 12month after enrollment', 'description': "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."}, {'measure': "multifocal approach to sharing in shared decision making(Mappin'SDM)", 'timeFrame': 'at enrollment, and 6month, 12month after enrollment', 'description': '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.'}, {'measure': 'Comparison of Quality of Life between the shared decision group and standard care group', 'timeFrame': 'at enrollment, and 6month, 12month after enrollment', 'description': "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."}, {'measure': 'Hospital Anxiety and Depression', 'timeFrame': 'at enrollment, and 6month, 12month after enrollment', 'description': "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."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Active surveillance', 'Shared decision making'], 'conditions': ['Thyroid Cancer', 'Papillary Thyroid Carcinoma']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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).\n\nExclusion Criteria:\n\n* Patients who cannot undergo regular follow-up or are expected to have difficulties with follow-up.\n* Patients with indeterminate or benign findings on thyroid biopsy.'}, 'identificationModule': {'nctId': 'NCT06730893', 'acronym': 'MAeSTro-SDM', 'briefTitle': 'Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer: a Multicenter Cluster-Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SDM Group (Shared Decision-Making Group; Intervention Group)', 'description': '* Patients will receive detailed information, including an information leaflet about treatment options.\n* Clinicians will guide patients through a structured SDM protocol before finalizing the treatment decision.', 'interventionNames': ['Other: SDM protocol']}, {'type': 'NO_INTERVENTION', 'label': 'SC Group (Standard Care Group; Control Group)', 'description': '\\- Patients will receive standard medical care following current clinical practices without the SDM protocol.'}], 'interventions': [{'name': 'SDM protocol', 'type': 'OTHER', 'description': 'Card news and Videos related to general knowledge and treatment of low-risk thyroid cancer', 'armGroupLabels': ['SDM Group (Shared Decision-Making Group; Intervention Group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eun Kyung Lee', 'role': 'CONTACT', 'email': 'eklee@ncc.re.kr', 'phone': '+82-31-920-1743'}], 'overallOfficials': [{'name': 'Young Joo Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Eun Kyung Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center'}, {'name': 'Min Joo Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}, {'name': 'Young Shin Song', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMC-SNU Boramae Medical Center'}, {'name': 'Kyong Yeun Jung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nowon Eulji Medical Center'}, {'name': 'Shin Je Moon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, {'name': 'Nowon Eulji Medical Center', 'class': 'UNKNOWN'}, {'name': 'Hanyang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}