Patient Education on Postoperative TSH Suppression Therapy for Differentiated Thyroid Cancer Using Science Popularization Videos: A Prospective, Multicenter, Randomized Controlled Trial
| Registry | NCT07823543 |
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, single group, masking: single, health services research |
| Enrollment | 400 (Estimated) |
| Sponsor | West China Hospital (Other) |
| Conditions | Thyroid Cancer, Thyroid Nodule, TSH, Education of Patients |
| Interventions | Thyroid Surgery Educational Video (Other) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-09-16, last updated 2026-09-16 |
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All trials for Thyroid Cancer All trials for Thyroid Nodule All trials of Thyroid Surgery Educational Video
-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Intervention group | Experimental | Other: Thyroid Surgery Educational Video | Accepting educational video on postoperative TSH suppression therapy for differentiated thyroid cancer produced by researchers in accordance with guidelines |
| Non-intervention group | No intervention | | Without any additional intervention |
- Thyroid Surgery Educational Video (Other): Accepting educational video on postoperative TSH suppression therapy for differentiated thyroid cancer created by researchers based on guidelines
+Outcome measures
Primary outcomes
- TSH Compliance Rate [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 [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).
Secondary outcomes
- Level of knowledge dissemination [Postoperative Month 1, Postoperative Month 3, Postoperative Month 6, and Postoperative Month 12]: Knowledge assessment consists of 6 multiple-choice questions, 2 true/false questions, and 2 fill-in-the-blank questions to evaluate patients' understanding and awareness of educational topic.
- Patient anxiety level [Baseline (before the educational outreach) and immediately after the educational outreach; two assessments total]: Anxiety scale, thereby assessing the patient's level of anxiety. A 5-point Likert scale was used, with each item scored on a scale of 1 to 5, ranging from "not at all" to "very severe."
- Patient's Level of Regret After Surgery [Baseline (before the educational outreach) and immediately after the educational outreach]: Regret Scale, thereby recording the patient's degree of postoperative regret. 1. This was the right decision.
2\. I regret making this choice. 3. If I had the chance to do it over, I would make the same choice. 4. This choice caused me a lot of pain. 5. This was a wise decision. A 5-point Likert scale was used, with each item scored on a scale of 1 to 5; the lower the score, the less regret the respondent felt.
- Incidence of adverse events in patients [Postoperative Month 1, Postoperative Month 3, and Postoperative Month 6]: Whether the patient has forgotten to take medication or mistakenly recorded the follow-up appointment time, etc.
+Eligibility
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
Inclusion Criteria:
* Patients scheduled for thyroid surgery, aged between 18 and 60 years old
Exclusion Criteria:
* 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.