Clinical trial NCT06800482: A Study of Online Follow-up in Patients With Papillary Thyroid Cancer
Official title: A Randomized Controlled Study of Online Outpatient Follow-up in Patients With Papillary Thyroid Cancer After Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid
Papillary Thyroid Cancer
Keywords: Papillary thyroid cancer
surgery
out-patient
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using the REDCap randomization module, a computer-generated permutation block randomization, with random block sizes of 6 and 9, randomly assigned participants to online or offline visits in a 1:1 manner. The assignment order is hidden, and the results of the post-assignment randomization are extracted by an independent data collection team. Participants who visit online are given a booklet detailing how to access the platform and create a secure login and a phone number to schedule an appointment. Participants who do not call within 3 working days of the expected follow-up time after discharge will be called up to 2 times by the outpatient assistant to schedule an appointment.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: The adherence to outpatient procedures
timeFrame: From enrollment to the end of follow-up at 12 months
Secondary outcomes:
measure: General life quality of participants
timeFrame: From enrollment to the end of follow-up at 12 months
Other outcomes:
measure: Thyroid related symptom score
timeFrame: From enrollment to the end of follow-up at 12 months
measure: Participants's satisfacation
timeFrame: From enrollment to the end of follow-up at 12 months
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References: