Anxiety, Depression, Distress, Fatigue, Thyroid Cancer
Conditions
Brief summary
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.
Interventions
DRUGComthyroid
T4/T3 combination replacement
DRUGSynthroid
T4 mono replacement
Sponsors
Dongnam Institute of Radiological & Medical Sciences
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patient who need thyroid hormone replacement therapy after total thyroidectomy for thyroid cancer 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
1. \< 19 or ≥ 70 years old 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological distress (depression or anxiety) assessed with HADS | baseline, 24 weeks | Change from baseline HADS total score at 24 weeks |
| Fatigue assessed with MDASI-F | baseline, 24 weeks | Change from baseline MDASI-F score at 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue assessed with BFI | baseline, 4, 12, 24 weeks | Change from baseline BFI total score at 24 weeks |
| Response rate using BDI | baseline, 4, 12, 24 weeks | improvement of depression sx. ≥ 50% |
| Response rate using BAI | baseline, 4, 12, 24 weeks | improvement of anxiety sx. ≥ 50% |
| Depression assessed with BDI | baseline, 4, 12, 24 weeks | Change from baseline BDI total score at 24 weeks |
| Remisssion rate using BDI | baseline, 4, 12, 24 weeks | — |
| Remission rate using BAI | baseline, 4, 12, 24 weeks | — |
| Remission rate using BFI | baseline, 4, 12, 24 weeks | — |
| Response rate using BFI | baseline, 4, 12, 24 weeks | improvement of fatigue sx. ≥ 50% |
| Anxiety assessed with BAI | baseline, 4, 12, 24 weeks | Change from baseline BAI total score at 24 weeks |
Countries
South Korea
Outcome results
None listed