A Study of Online Follow-up in Patients With Papillary Thyroid Cancer

Официальное название

A Randomized Controlled Study of Online Outpatient Follow-up in Patients With Papillary Thyroid Cancer After Surgery

Обзор

The randomized, actively controlled, non-inferiority trial is scheduled to begin in August 2024 and run through August 2026. Inclusion criteria: (1) has undergone microwave ablation of thyroid or thyroidectomy (including endoscopy and opening) at the Department of Thyroid Surgery of West China Hospital of Sichuan University, (2) is between 18 and 90 years old, (3) speaks Chinese, (4) has the email address and operational ability required to complete the visit, (5) does not have a mental illness or take psychotropic drugs, (6) Voluntarily participate in clinical trials and sign informed consent. Exclusion criteria: (1) postoperative hospital stay more than 3 days; (2) Inability to complete an online visit (no access to the device or the Internet); (3) High risk of postoperative complications (recurrent laryngeal nerve injury, etc.); (4) Inability to participate due to a medical condition, laboratory test results, or physical disability (as determined by the principal investigator or surgeon). The online outpatient follow-up was completed by thyroid surgeons of West China Hospital. Informed consent signed with a voluntary participant after a research team member contacts the patient and introduces the patient to the study. The investigators who contacted, enrolled, and randomly assigned patients included the principal investigator, the study coordinator, and the research assistant who had been specially trained in the study. According to the agreement, the participants randomly assigned to online visits will cross over with offline visits and withdraw from the clinical trial if :(1) unresolved technical issues, (2) inability to perform a full evaluation, (3) need/request prescription painkillers, and (4) additional care recommended by a physician. Other cross-cutting reasons include patient requests and scheduling conflicts. The information department of WestChina hospital obtained online and offline participants' demographic data and comorbidities, related information of chief complaint (including time of illness, information of last visit, drugs being used, contents of consultation, disease symptoms, conclusions of consultation, etc.), and online and offline outpatient information (including application time, reception time, patient satisfaction, etc.). Whether to prescribe medicine, whether to prescribe examination/admission certificate, outpatient cost, number of questions, number of return visits, etc.) Employment, living conditions and the highest education level were obtained through the questionnaire survey at the time of enrollment, and the information about participant experience and satisfaction was obtained through the questionnaire survey after follow-up. The investigators recorded the diagnosis and treatment details of the patients at three online/offline follow-up visits at 1, 3, and 6 months after surgery. The investigators reviewed the electronic medical record 30 days after the last follow-up to monitor for adverse events. Participants were surveyed by email 30 days after the last follow-up to assess adverse events, including readmissions. If the survey is not answered within a week, an electronic reminder is sent and two attempts are made to contact the participants by phone.

Вмешательства

• Поведенческое online outpatient follow-up
  The investigators use Huayitong APP for the post-operating follow-up of participants with papillary thyroid cancer

Первичные конечные точки

• The adherence to outpatient procedures [Срок оценки: From enrollment to the end of follow-up at 12 months]

Вторичные конечные точки (1)

• General life quality of participants [Срок оценки: From enrollment to the end of follow-up at 12 months]

Критерии участия

Inclusion Criteria：

• clinical diagnosis of papillary thyroid cancer
• has underwent thyroid surgery (including endoscopic and open thyroid surgery)
• 18 to 90 years of age
• spoke Chinese
• has the ability to use mobile phones and the Internet to complete the visit
• voluntarily participate in clinical trials and sign informed consent.

Exclusion Criteria：

• postoperative hospital stay more than 5 days
• inability to complete an online visit (no access to the device or the Internet
• high risk of postoperative complications (recurrent laryngeal nerve injury, etc.)
• unable to participate due to comorbidities, laboratory test results or physical disability
• pregnancy
• has mental illness or take psychotropic drugs, and were not able to perform the surgery

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• West China Hospital — Чэнду

Идентификаторы

NCT: NCT06800482 · WestChinaH20241018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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