Patient Education on Postoperative TSH Suppression Therapy for Differentiated Thyroid Cancer Using Science Popularization Videos: A Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- TSH Compliance Rate
研究概览
简要总结
The researchers aim to evaluate the performance of two groups of participants after receiving traditional education-one group supplemented with video-based education and the other without. This study will explore the feasibility of using guideline-based public education videos on postoperative TSH suppression therapy for differentiated thyroid cancer in the context of public education regarding thyroid surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for thyroid surgery, aged between 18 and 60 years old
排除标准
- •Unable to read and write, pregnant, or with a history of thyroid surgery;
- •suffering from other malignant tumors or mental disorders;
- •unable to complete the questionnaire independently or requiring assistance from others.
研究组 & 干预措施
Intervention group
Accepting educational video on postoperative TSH suppression therapy for differentiated thyroid cancer produced by researchers in accordance with guidelines
干预措施: Thyroid Surgery Educational Video (Other)
Non-intervention group
Without any additional intervention
结局指标
主要结局
TSH Compliance Rate
时间窗: Postoperative Month 1, Postoperative Month 3, Postoperative Month 6, and Postoperative Month 12
The criteria for determining the TSH target achievement rate are based on a combination of three factors: the patient's postoperative recurrence risk stratification, the follow-up time point, and the current TSH test result. Within one year postoperatively, the TSH suppression targets are \< 0.1 mU/L for the high-risk group, 0.1-0.5 mU/L for the moderate-risk group, and 0.1-0.5 mU/L (low Tg) or 0.5-2 mU/L (undetectable Tg, lobectomy) for the low-risk group. In statistical analysis, the TSH target range attainment rate = (number of patients with TSH levels within the target range at each follow-up time point / total number of patients followed up at that time point) × 100%
Patient satisfaction
时间窗: Immediately after the educational presentation (post-intervention)
Patient satisfaction following different educational approaches was assessed using a 5-point Likert scale (1-5 scale; the higher the score, the higher the satisfaction).
次要结局
- Level of knowledge dissemination(Postoperative Month 1, Postoperative Month 3, Postoperative Month 6, and Postoperative Month 12)
- Patient anxiety level(Baseline (before the educational outreach) and immediately after the educational outreach; two assessments total)
- Patient's Level of Regret After Surgery(Baseline (before the educational outreach) and immediately after the educational outreach)
- Incidence of adverse events in patients(Postoperative Month 1, Postoperative Month 3, and Postoperative Month 6)
研究者
Jianyong Lei
Professor
West China Hospital