ThyroidNCT06800482
A Study of Online Follow-up in Patients With Papillary Thyroid Cancer
A study testing online outpatient follow-up in people with Thyroid and Papillary Thyroid Cancer, run by West China Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid, Papillary Thyroid Cancer
- What is being tested?
- online outpatient follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2024to 7 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Jianyong Lei, MD, 86-19983137992, leijianyong@scu.edu.cn
Xinyi Wang, MD
About this study
Official title: 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.
Read more
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
- Being tested
- online outpatient follow-up
- Keywords
- Papillary thyroid cancer, surgery, out-patient
- Medical subject headings
- Thyroid Diseases, Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online outpatient follow-upBehavioural
The investigators use Huayitong APP for the post-operating follow-up of participants with papillary thyroid cancer
| Study group | Role | What they receive |
|---|---|---|
| Using Huayitong APP in participants with papillary thyroid cancer | Active comparator | Post-operative follow-up was performed using Huayitong APP Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of follow-up at 12 months
Secondary outcomes (1)
General life quality of participants
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.
Measured: From enrollment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start7 Aug 2024
- Primary completion7 Aug 2026 (estimated)
- Study completion7 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyi Wang, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800482
- Sponsor's protocol ID
- WestChinaH20241018
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Online Outpatient Follow-up in Patients With Papillary Thyroid Cancer After Surgery
- ClinicalTrials.gov ID
- NCT06800482
- Acronym / sponsor ID
- WestChinaH20241018
- Conditions
- Thyroid, Papillary Thyroid Cancer
- Keywords
- Papillary thyroid cancer, surgery, out-patient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 7 Aug 2026 (estimated)
- Study completion
- 7 Oct 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Using Huayitong APP in participants with papillary thyroid cancer | Active comparator | Behavioral: online outpatient follow-upPost-operative follow-up was performed using Huayitong APP |
| standard offline outpatient follow-up in patients with papillary thyroid cancer | No intervention | –Participants were followed up in traditional offline outpatient clinics |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online outpatient follow-upThe investigators use Huayitong APP for the post-operating follow-up of participants with papillary thyroid cancer | Behavioural | Using Huayitong APP in participants with papillary thyroid cancer |
Primary outcome
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.
1 secondary outcome
General life quality of participants
Time frame: From enrollment to the end of follow-up at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online outpatient follow-up in people with Thyroid and Papillary Thyroid Cancer, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianyong Lei, Md (86-19983137992, leijianyong@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adherence to outpatient procedures (time frame: From enrollment to the end of follow-up at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.