NCT03024151已完成不适用
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Psychological distress (depression or anxiety) assessed with HADS
研究概览
简要总结
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.
- 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.
- Randomization:
- Using the table of random sampling numbers, patients assign to T4 mono replacement group or T4/T3 combination replacement group.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who need thyroid hormone replacement therapy after total thyroidectomy for thyroid cancer
- •HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, or MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4
- •Patient who maintain TSH recommendation range for TSH suppression according to ATA guidelines
排除标准
- •< 19 or ≥ 70 years old
- •Communication difficulties or inability to complete the necessary investigations and questionnaires
- •Inability to understand purpose of the study or disagree of participation
- •Past history of psychiatric treatment or diagnosis
- •Lactation or pregnancy
- •Past medical history of other cancer diagnosis or treatment
- •Any of severe comorbid medical conditions according to ASA score ≥ 3
研究组 & 干预措施
T4/T3 combination replacement
Active Comparator
Comthyroid
干预措施: Comthyroid (Drug)
T4 mono replacement
Active Comparator
Synthroid
干预措施: Synthroid (Drug)
结局指标
主要结局
Psychological distress (depression or anxiety) assessed with HADS
时间窗: baseline, 24 weeks
Change from baseline HADS total score at 24 weeks
Fatigue assessed with MDASI-F
时间窗: baseline, 24 weeks
Change from baseline MDASI-F score at 24 weeks
次要结局
- Depression assessed with BDI(baseline, 4, 12, 24 weeks)
- Anxiety assessed with BAI(baseline, 4, 12, 24 weeks)
- Fatigue assessed with BFI(baseline, 4, 12, 24 weeks)
- Response rate using BDI(baseline, 4, 12, 24 weeks)
- Response rate using BAI(baseline, 4, 12, 24 weeks)
- Response rate using BFI(baseline, 4, 12, 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)
研究者
研究点 (2)
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