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

January 28, 2025 updated by: Xinyi Wang, West China Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

388

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital
        • Contact:
        • Contact:
          • Xinyi Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Using Huayitong APP in participants with papillary thyroid cancer
Post-operative follow-up was performed using Huayitong APP
Behavioral: online outpatient follow-up
The investigators use Huayitong APP for the post-operating follow-up of participants with papillary thyroid cancer
No Intervention: standard offline outpatient follow-up in patients with papillary thyroid cancer
Participants were followed up in traditional offline outpatient clinics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The adherence to outpatient procedures
Time Frame: 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.
From enrollment to the end of follow-up at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General life quality of participants
Time Frame: 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.
From enrollment to the end of follow-up at 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyroid related symptom score
Time Frame: From enrollment to the end of follow-up at 12 months

Questionnaire assessment for each assessment time point will be conducted by study participants 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.

Thyroid related symptom scores are measured by the thyroid cancer-specific quality of life questionnaire (THYCA-QoL), referring to the following articles: PMID: 33896584, PMID: 23013266.
From enrollment to the end of follow-up at 12 months
Participants's satisfacation
Time Frame: From enrollment to the end of follow-up at 12 months
Questionnaire assessment for each assessment time point will be conducted by study participants 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 satisfaction with the doctor are granded from 1 to 10, with 1 is the least satisfied and 10 is the most satisfied.
From enrollment to the end of follow-up at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2024

Primary Completion (Estimated)

August 7, 2026

Study Completion (Estimated)

October 7, 2026

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaH20241018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid

Clinical Trials on online outpatient follow-up

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe