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

NCT06800482 | Recruiting DMC

• 1 other identifier: WestChinaH20241018
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid; Papillary Thyroid Cancer

Keywords

Papillary thyroid cancer; surgery; out-patient

Outcome Measures

Primary Outcomes (1)

• The adherence to outpatient procedures

  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 Outcomes (1)

• General life quality of participants

  From enrollment to the end of follow-up at 12 months

Other Outcomes (2)

• Thyroid related symptom score

  From enrollment to the end of follow-up at 12 months

• Participants's satisfacation

  From enrollment to the end of follow-up at 12 months

Study Arms (2)

Using Huayitong APP in participants with papillary thyroid cancer

ACTIVE COMPARATOR

Post-operative follow-up was performed using Huayitong APP

Behavioral: online outpatient follow-up

standard offline outpatient follow-up in patients with papillary thyroid cancer

NO INTERVENTION

Participants were followed up in traditional offline outpatient clinics

Interventions

online outpatient follow-up BEHAVIORAL

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

Using Huayitong APP in participants with papillary thyroid cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of papillary thyroid cancer
• has underwent thyroid surgery (including endoscopic and open thyroid surgery)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases; Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Central Study Contacts

Jianyong Lei, Md

CONTACT

86-19983137992; leijianyong@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 30, 2025
• Study Start: August 7, 2024
• Primary Completion (Estimated): August 7, 2026
• Study Completion (Estimated): October 7, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

CN (1)