- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07589660
Structured Active Follow-up in Postoperative Management of Thyroid
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yu Feng
- Número de telefone: 15183042703
- E-mail: 1350502131@qq.com
Locais de estudo
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recrutamento
- West China Hospital of Sichuan University
-
Contato:
- Yu Feng
- Número de telefone: 15183042703
- E-mail: 1350502131@qq.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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)
|
|
Sem intervenção: Conventional Passive Follow-up Group
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Completion Rate of Scheduled In-Person Clinic Visits
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
TSH suppression target achievement rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2026 (101)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Structured Active Follow-up
-
Centre Hospitalier Universitaire de NiceAinda não está recrutando
-
University of WashingtonNational Institute on Aging (NIA); Kaiser PermanenteConcluídoSintomas Comportamentais | Demência | Doença de Alzheimer | Sobrecarga do cuidadorEstados Unidos
-
Region SkaneConcluídoOsteoartrite do quadrilSuécia
-
Poitiers University HospitalAinda não está recrutando
-
Institut Claudius RegaudConcluído
-
Science Valley Research InstituteWyeth is now a wholly owned subsidiary of PfizerRecrutamentoIsquemia Crítica de MembroBrasil