Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Structured Active Follow-up in Postoperative Management of Thyroid

10. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Studientyp

Interventionell

Einschreibung (Geschätzt)

244

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Rekrutierung
        • West China Hospital of Sichuan University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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)
Kein Eingriff: Conventional Passive Follow-up Group

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Completion Rate of Scheduled In-Person Clinic Visits
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
TSH suppression target achievement rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

31. Januar 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. April 2028

Studienanmeldedaten

Zuerst eingereicht

10. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Mai 2026

Zuerst gepostet (Tatsächlich)

15. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 2026 (101)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Structured Active Follow-up

Abonnieren