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

Not Applicable

Recruiting

• Conditions: Thyroid; Papillary Thyroid Cancer

• Registration Number: NCT06800482
• Lead Sponsor: West China Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-07
• Study First Submitted: 2024-11-28
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30
• Primary Completion: 2026-08-07
• Study Completion: 2026-10-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The adherence to outpatient procedures	From enrollment to the end of follow-up at 12 months	At 12 months after the operation, the participants' medical information is extracted through the electronic recording system of Huatong APP to determine whether the participants complied with the random group for postoperative follow-up. The data were extracted by the Information Department of West China Hospital.

Secondary Outcome Measures

Name	Time	Method
General life quality of participants	From enrollment to the end of follow-up at 12 months	Questionnaire assessment for each assessment time point will be conducted in the thyroid surgery ward of West China Hospital of Sichuan University. Before each assessment time point, the investigators will notify the participants in advance by phone or wechat and inform them of relevant precautions. Participant's life qualities are measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-C30), referring to the following articles: PMID: 36376888, PMID: 34985562.

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China