The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients
NCT ID: NCT03024151
Last Updated: 2019-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2016-12-31
2017-11-30
Brief Summary
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1. Subjects:
* 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.
2. Randomization:
* Using the table of random sampling numbers, patients assign to T4 mono replacement group or T4/T3 combination replacement group.
3. Evaluation for distress:
* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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T4/T3 combination replacement
Comthyroid
Comthyroid
T4/T3 combination replacement
T4 mono replacement
Synthroid
Synthroid
T4 mono replacement
Interventions
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Comthyroid
T4/T3 combination replacement
Synthroid
T4 mono replacement
Eligibility Criteria
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Inclusion Criteria
2. HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, or MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4
3. Patient who maintain TSH recommendation range for TSH suppression according to ATA guidelines
Exclusion Criteria
2. Communication difficulties or inability to complete the necessary investigations and questionnaires
3. Inability to understand purpose of the study or disagree of participation
4. Past history of psychiatric treatment or diagnosis
5. Lactation or pregnancy
6. Past medical history of other cancer diagnosis or treatment
7. Any of severe comorbid medical conditions according to ASA score ≥ 3
20 Years
70 Years
ALL
No
Sponsors
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Dongnam Institute of Radiological & Medical Sciences
OTHER
Inje University
OTHER
Responsible Party
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Dongsik Bae
Professor
Locations
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Dong sik Bae
Busan, , South Korea
Dongsik Bae
Busan, , South Korea
Countries
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Other Identifiers
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2016-05-010-001
Identifier Type: -
Identifier Source: org_study_id
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