Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Structured Active Follow-up in Postoperative Management of Thyroid

10 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Typ studiów

Interwencyjne

Zapisy (Szacowany)

244

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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)
Brak interwencji: Conventional Passive Follow-up Group

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Completion Rate of Scheduled In-Person Clinic Visits
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
TSH suppression target achievement rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

31 stycznia 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2027

Ukończenie studiów (Szacowany)

1 kwietnia 2028

Daty rejestracji na studia

Pierwszy przesłany

10 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 maja 2026

Pierwszy wysłany (Rzeczywisty)

15 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 2026 (101)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Structured Active Follow-up

Subskrybuj