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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
T4/T3 combination replacement
T4 mono replacement
Dong sik Bae
Busan, South Korea
Dongsik Bae
Busan, South Korea
Psychological distress (depression or anxiety) assessed with HADS
Change from baseline HADS total score at 24 weeks
Time frame: baseline, 24 weeks
Fatigue assessed with MDASI-F
Change from baseline MDASI-F score at 24 weeks
Time frame: baseline, 24 weeks
Depression assessed with BDI
Change from baseline BDI total score at 24 weeks
Time frame: baseline, 4, 12, 24 weeks
Anxiety assessed with BAI
Change from baseline BAI total score at 24 weeks
Time frame: baseline, 4, 12, 24 weeks
Fatigue assessed with BFI
Change from baseline BFI total score at 24 weeks
Time frame: baseline, 4, 12, 24 weeks
Response rate using BDI
improvement of depression sx. ≥ 50%
Time frame: baseline, 4, 12, 24 weeks
Response rate using BAI
improvement of anxiety sx. ≥ 50%
Time frame: baseline, 4, 12, 24 weeks
Response rate using BFI
improvement of fatigue sx. ≥ 50%
Time frame: baseline, 4, 12, 24 weeks
Remisssion rate using BDI
Time frame: baseline, 4, 12, 24 weeks
Remission rate using BAI
Time frame: baseline, 4, 12, 24 weeks
Remission rate using BFI
Time frame: baseline, 4, 12, 24 weeks
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