Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT03024151
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2017-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D005221', 'term': 'Fatigue'}], '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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-15', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological distress (depression or anxiety) assessed with HADS', 'timeFrame': 'baseline, 24 weeks', 'description': 'Change from baseline HADS total score at 24 weeks'}, {'measure': 'Fatigue assessed with MDASI-F', 'timeFrame': 'baseline, 24 weeks', 'description': 'Change from baseline MDASI-F score at 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Depression assessed with BDI', 'timeFrame': 'baseline, 4, 12, 24 weeks', 'description': 'Change from baseline BDI total score at 24 weeks'}, {'measure': 'Anxiety assessed with BAI', 'timeFrame': 'baseline, 4, 12, 24 weeks', 'description': 'Change from baseline BAI total score at 24 weeks'}, {'measure': 'Fatigue assessed with BFI', 'timeFrame': 'baseline, 4, 12, 24 weeks', 'description': 'Change from baseline BFI total score at 24 weeks'}, {'measure': 'Response rate using BDI', 'timeFrame': 'baseline, 4, 12, 24 weeks', 'description': 'improvement of depression sx. ≥ 50%'}, {'measure': 'Response rate using BAI', 'timeFrame': 'baseline, 4, 12, 24 weeks', 'description': 'improvement of anxiety sx. ≥ 50%'}, {'measure': 'Response rate using BFI', 'timeFrame': 'baseline, 4, 12, 24 weeks', 'description': 'improvement of fatigue sx. ≥ 50%'}, {'measure': 'Remisssion rate using BDI', 'timeFrame': 'baseline, 4, 12, 24 weeks'}, {'measure': 'Remission rate using BAI', 'timeFrame': 'baseline, 4, 12, 24 weeks'}, {'measure': 'Remission rate using BFI', 'timeFrame': 'baseline, 4, 12, 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thyroid Cancer', 'Distress', 'Depression', 'Anxiety', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'The goal of this research is to compare the effects on psychological distress between T4 mono replacement group and T4/T3 combination replacement group after total thyroidectomy in thyroid cancer patients.\n\n1. Subjects:\n\n * Psychologically distressed patients, such as depression, anxiety, and fatigue patient after total thyroidectomy with thyroid cancer are considered for participation. Screening of distress after total thyroidectomy is used HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, and MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4 for fatigue.\n2. Randomization:\n\n * Using the table of random sampling numbers, patients assign to T4 mono replacement group or T4/T3 combination replacement group.\n3. Evaluation for distress:\n\n * Assessment will be made baseline, 4 weeks, 12 weeks and 24 weeks to investigate change of psychological distress (depression, anxiety, and fatigue). Level of distress after thyroidectomy will determine using Hospital Anxiety and Depression Scale (HADS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) for depression or anxiety, and Brief Fatigue Inventory (BFI) for fatigue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient who need thyroid hormone replacement therapy after total thyroidectomy for thyroid cancer\n2. HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, or MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4\n3. Patient who maintain TSH recommendation range for TSH suppression according to ATA guidelines\n\nExclusion Criteria:\n\n1. \\< 19 or ≥ 70 years old\n2. Communication difficulties or inability to complete the necessary investigations and questionnaires\n3. Inability to understand purpose of the study or disagree of participation\n4. Past history of psychiatric treatment or diagnosis\n5. Lactation or pregnancy\n6. Past medical history of other cancer diagnosis or treatment\n7. Any of severe comorbid medical conditions according to ASA score ≥ 3'}, 'identificationModule': {'nctId': 'NCT03024151', 'briefTitle': 'The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'The Effects of T4 Mono Replacement Versus T4/T3 Combination Replacement on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients; Prospective, Randomized, Double Blind, T4 Comparative Clinical Study', 'orgStudyIdInfo': {'id': '2016-05-010-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'T4/T3 combination replacement', 'description': 'Comthyroid', 'interventionNames': ['Drug: Comthyroid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'T4 mono replacement', 'description': 'Synthroid', 'interventionNames': ['Drug: Synthroid']}], 'interventions': [{'name': 'Comthyroid', 'type': 'DRUG', 'description': 'T4/T3 combination replacement', 'armGroupLabels': ['T4/T3 combination replacement']}, {'name': 'Synthroid', 'type': 'DRUG', 'description': 'T4 mono replacement', 'armGroupLabels': ['T4 mono replacement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong sik Bae', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Dongsik Bae', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dongnam Institute of Radiological & Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dongsik Bae', 'investigatorAffiliation': 'Inje University'}}}}