Structured Active Follow-up in Postoperative Management of Thyroid

Официальное название

Comparative Effectiveness of Structured Active Follow-up Versus Conventional Passive Follow-up in Postoperative Management of Thyroid: A Prospective Cohort Study

Обзор

Patients after thyroid cancer surgery face multiple challenges, including recurrence monitoring, medication adjustment, complication management (e.g., hypoparathyroidism, vocal cord dysfunction), and long-term psychosocial adaptation. Studies confirm that standardized long-term follow-up can raise 5-year survival rates to over 90% and significantly reduce disability and mortality in patients with thyroid dysfunction. Despite the recognized importance of follow-up, conventional practice has major limitations. The traditional model relies on passive patient return visits, either when symptoms appear or at fixed intervals. Adherence is influenced by patients' health awareness, education, geographic distance, finances, and work obligations. Consequently, loss to follow-up and delayed follow-up are common. Clinical data from China show that follow-up adherence drops from less than 60% at one year post-surgery to below 40% at three years. Many patients experience disease progression or treatment delays, increasing their physical and psychological burden, as well as healthcare costs. Physicians face high clinic workloads, fragmented patient information, and difficulty tracking long-term outcomes. Furthermore, conventional follow-up lacks personalized plans-timing, content, and methods are uniform, making it difficult to meet diverse patient needs. Poor communication and delayed information transfer further undermine follow-up quality. In response, a patient-centered, proactive, structured, and full-cycle health management approach has become a new direction for chronic cancer care. Our hospital has introduced the "Follow-up Package (Proactive Postoperative Follow-up Program)," an innovative model that integrates several scheduled in-person specialty visits, interdisciplinary referral resources, convenient online consultation channels, and an AI-based automated reminder system into an annual service. This proactive model shifts from "passive patient return" to "active hospital-led management." It clarifies follow-up timelines, diversifies service formats, strengthens doctor-patient communication, and creates a seamless, responsive management loop. For patients, this approach offers clearer management pathways, stronger support, and improved access to care. For the healthcare system, it enables more efficient disease management through optimized resource allocation and early detection of problems. By transforming follow-up from a passive, episodic task into an active, continuous partnership, the program addresses the key shortcomings of conventional models-low adherence, lack of personalization, and poor communication-and holds promise for better clinical outcomes and more sustainable use of medical resources.

Вмешательства

• Поведенческое Structured Active Follow-up
  Proactive Postoperative Follow-up Program (including scheduled in-person clinic visits, interdisciplinary referrals, online consultation channels, and AI-based automated reminders)

Первичные конечные точки

• Completion Rate of Scheduled In-Person Clinic Visits [Срок оценки: 1 month postoperatively；3 months postoperatively；6 months postoperatively；12 months postoperatively]

Вторичные конечные точки (8)

• TSH suppression target achievement rate [Срок оценки: 1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively]
• Median time to TSH suppression target achievement [Срок оценки: 1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively]
• Patient Medication Adherence Score [Срок оценки: 1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively]
• Patient Satisfaction Score [Срок оценки: 1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively]
• Completion rate and accuracy rate of key examinations [Срок оценки: 1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively]
• Questionnaire completion rate [Срок оценки: 1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively]
• Timely management rate of post-discharge complications [Срок оценки: 1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively]
• Oncological safety [Срок оценки: 1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively]

Критерии участия

Критерии включения

• Patients aged 18-75 years (including 18 and 75 years)
• Patients who have undergone thyroid surgery (including endoscopic surgery, open surgery, etc.) at this study center
• Patients who are conscious, able to communicate in Chinese, and have the necessary smartphone and internet skills to complete outpatient visits (to meet the online functionality requirements of the active follow-up program)
• Patients who voluntarily agree to participate in the study and are able to sign the informed consent form

Критерии исключения

• Patients with other serious illnesses requiring frequent hospital visits or long-term hospitalization (e.g., advanced malignant tumors, severe heart failure, etc.) that may interfere with the assessment of follow-up adherence
• Patients with anaplastic thyroid cancer or distant metastasis, who have an extremely short life expectancy and cannot complete one year of follow-up
• Patients with cognitive impairment or mental illness who are unable to complete the questionnaires
• Patients who plan to move out of the local area within 2 years after surgery and are unable to complete long-term follow-up
• Patients who are pregnant, lactating, or planning to become pregnant within one year
• Patients currently participating in another clinical study that may interfere with their participation in this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• West China hospital of Sichuan University — Чэнду

Публикации

• Graetz I, Hu X, Kocak M, Krukowski RA, Anderson JN, Waters TM, Curry AN, Robles A, Paladino A, Stepanski E, Vidal GA, Schwartzberg LS. Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417873. doi: 10.1001/jamanetworkopen.2024.17873. PMID 38935379
• Javidi S, Sadrizadeh S, Sadrizadeh A, Bonakdaran S, Jarahi L. Postoperative complications and long-term outcomes after total and subtotal thyroidectomy: a retrospective study. Sci Rep. 2025 Jan 29;15(1):3705. doi: 10.1038/s41598-024-79860-8. PMID 39881145
• Durante C, Grani G, Lamartina L, Filetti S, Mandel SJ, Cooper DS. The Diagnosis and Management of Thyroid Nodules: A Review. JAMA. 2018 Mar 6;319(9):914-924. doi: 10.1001/jama.2018.0898. PMID 29509871

Идентификаторы

NCT: NCT07589660 · 2026 （101）

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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