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Structured Active Follow-up in Postoperative Management of Thyroid

2026年5月10日 更新者:Yu Feng

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

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.

調査の概要

研究の種類

介入

入学 (推定)

244

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • 募集
        • West China Hospital of Sichuan University
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Structured Active Follow-up Group
Proactive Postoperative Follow-up Program (including scheduled in-person clinic visits, interdisciplinary referrals, online consultation channels, and AI-based automated reminders)
介入なし:Conventional Passive Follow-up Group

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Completion Rate of Scheduled In-Person Clinic Visits
時間枠:1 month postoperatively;3 months postoperatively;6 months postoperatively;12 months postoperatively
Compare the proportion of scheduled in-person clinic visits completed within the predefined follow-up time windows (postoperative month 1 ± 7 days, month 3 ± 14 days, month 6 ± 14 days, month 12 ± 30 days) during the first year after surgery between the two groups. Additionally, calculate separately the proportion of patients in each group who completed the in-person clinic visit within each predefined follow-up time window.
1 month postoperatively;3 months postoperatively;6 months postoperatively;12 months postoperatively

二次結果の測定

結果測定
メジャーの説明
時間枠
TSH suppression target achievement rate
時間枠:1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
Proportion of patients who achieve the TSH suppression goal within the specified measurement time points.
1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
Median time to TSH suppression target achievement
時間枠:1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
The median time to achieve the TSH suppression goal within the specified measurement time points.
1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
Patient Medication Adherence Score
時間枠:1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
The Morisky Medication Adherence Scale (MMAS-8) is an internationally recognized, standardized self-reported tool for measuring long-term medication adherence in patients with chronic diseases. It was revised and developed in 2008 by American scholar Donald E. Morisky and his team based on their earlier 4-item questionnaire (MMAS-4). The original intention of its design was to more comprehensively and sensitively capture the multidimensional reasons for poor adherence, including forgetfulness, negligence, dose reduction or discontinuation after symptom improvement, and discontinuation due to side effects or perceived worsening of the condition. The scale was initially developed specifically for chronic diseases requiring long-term medication, such as hypertension, and has since been validated for use in various chronic conditions, including thyroid diseases, diabetes, cardiovascular diseases, HIV/AIDS, and others. The MMAS-8 consists of 8 questions: the first 7 are dichotomous (yes/no
1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
Patient Satisfaction Score
時間枠:1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
Assessed using the Client Satisfaction Questionnaire (CSQ-8). This satisfaction score is assessed only for patients in the intervention group, to understand their level of satisfaction with the active follow-up intervention.
1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
Completion rate and accuracy rate of key examinations
時間枠:1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
Whether the thyroid function tests, serum calcium, parathyroid hormone (PTH) tests, and thyroid ultrasound recommended by clinical guidelines and/or the medical team were completed at the time of postoperative outpatient follow-up visits (yes/no), as well as the proportion of missed or unnecessary (excessive) examinations.
1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
Questionnaire completion rate
時間枠:1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
The proportion of questionnaires completed by patients in both groups at each time point and within one year after surgery.
1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
Timely management rate of post-discharge complications
時間枠:1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
The time to management of thyroid surgery-related complications occurring after hospital discharge will be collected, and the rate of timely management of complications will be compared between the two groups.
1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
Oncological safety
時間枠:1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively
The proportion of patients in both groups who develop recurrence or distant metastasis during the follow-up period will be collected.
1 month postoperatively; 3 months postoperatively; 6 months postoperatively; 12 months postoperatively

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月31日

一次修了 (推定)

2027年4月1日

研究の完了 (推定)

2028年4月1日

試験登録日

最初に提出

2026年5月10日

QC基準を満たした最初の提出物

2026年5月10日

最初の投稿 (実際)

2026年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月15日

QC基準を満たした最後の更新が送信されました

2026年5月10日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2026 (101)

個々の参加者データ (IPD) の計画

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医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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