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Thyroid CancerNCT06804863

Regret Emotion After Thyroidectomy in Low-Risk Papillary Thyroid Cancer

A study testing Postoperative Regret Reduction through Immediate Quality of Life Intervention in people with Thyroid Cancer and Regret, run by West China Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This randomized, active-controlled, non-inferiority trial is scheduled to begin in May 2025 and will continue until June 2027. Inclusion criteria: (1) Patients with low-risk papillary thyroid cancer without lymph node metastasis who have undergone thyroid surgery (including both laparoscopic and open surgery) at the… Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Thyroid Cancer, Regret
What is being tested?
Postoperative Regret Reduction through Immediate Quality of Life Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteChina
Study dates
1 May 2025to 30 May 2027
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

  • Patients with low-risk papillary thyroid cancer without lymph node metastasis who have undergone thyroid surgery,
  • Aged between 18 and 90 years,
  • Chinese-speaking,
  • Capable of completing questionnaires and using a mobile phone and internet for intervention purposes,
  • No history of psychiatric disorders or use of psychotropic medications,
  • Voluntary participation and signing of an informed consent form.

Who cannot join

  • Patients with cervical lymph node metastasis,
  • Incomplete baseline data,
  • Uncontrolled chronic diseases,
  • Patients with other cancers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianyong Lei, Md contact

86-19983137992

leijianyong@scu.edu.cn

China1 site
  • West China Hospital

    Chengdu, Sichuan, 610041

    Jianyong Lei, MD, 86-19983137992, leijianyong@scu.edu.cn

    Ziyang Ye, Dr, 86-16605758778

Other trials in China

About this study

Official title: Monitoring and Timely Intervention of Regret Emotion After Thyroidectomy in Low-Risk Papillary Thyroid Cancer Patients: A Multicenter, Randomized, Controlled Trial

This randomized, active-controlled, non-inferiority trial is scheduled to begin in May 2025 and will continue until June 2027. Inclusion criteria: (1) Patients with low-risk papillary thyroid cancer without lymph node metastasis who have undergone thyroid surgery (including both laparoscopic and open surgery) at the Department of Thyroid Surgery, West China Hospital, Sichuan University, (2) Aged between 18 and 90 years, (3) Chinese-speaking, (4) Capable of completing questionnaires and using a mobile phone and internet for intervention purposes, (5) No history of psychiatric disorders or use of psychotropic medications, (6) Voluntary participation and signing of an informed consent form. Exclusion criteria: (1) Patients with cervical lymph node metastasis, (2) Incomplete baseline data, (3) Uncontrolled chronic diseases, (4) Patients with other cancers. Online outpatient follow-up will be conducted by doctors from the Department of Thyroid Surgery at West China Hospital. One study participant will contact the patient, introduce the study, and obtain the informed consent form from willing participants. The research team members responsible for patient contact, registration, and randomization include the principal investigator, study coordinator, and specially trained research assistants. The management of the intervention group patients will be carried out by doctors from the corresponding departments. According to the protocol, patients assigned to online visits will switch to offline visits and exit the clinical trial under the following circumstances: (1) unresolved technical issues, (2) inability to perform a comprehensive assessment, (3) patient request for withdrawal. Other cross-cutting reasons include patient requests and scheduling conflicts. Baseline data (including age, gender, ethnicity, address, occupation), tumor-related information (including tumor histology, maximum tumor diameter, capsular invasion status, number of lymph node metastases), and surgical method will be collected from the hospital's information department. Participants will be given the DRS scale upon discharge and every two months thereafter to assess their regret status. For patients with high regret (DRS score >25), a QoL scale will be further distributed to collect information about their quality of life. The REDCap randomization module will be used, and block randomization will be computer-generated with block sizes of 6 and 9, in a 1:1 ratio, to allocate patients to either the intervention or control group. The allocation sequence will be concealed, and the randomized results will be extracted by an independent data collection team. If intervention group patients need to complete the QoL scale, after completion, the doctor from the department corresponding to the factor with the highest score (i.e., the factor most closely related to the patient's regret state) will receive an SMS notification and will be required to contact the patient by phone or SMS within 24 hours to provide the intervention. If contact is not established within 24 hours of the intervention phase, the research participant will call the patient up to two times to clarify the reason.

Being tested
Postoperative Regret Reduction through Immediate Quality of Life Intervention
Keywords
Papillary thyroid cancer, regret, active intervention, prognosis
Medical subject headings
Thyroid Neoplasms, Thyroid Cancer, Papillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postoperative Regret Reduction through Immediate Quality of Life InterventionBehavioural

    Immediate intervention of the major impaired quality of life factors postoperatively to reduce patients' postoperative regret.

Study groups in NCT06804863
Study groupRoleWhat they receive
Intervening in patients with postoperative regret emotion.ExperimentalFor the worst postoperative quality of life factors reported by patients, specialized doctors will provide immediate guidance and management via SMS or phone.
Receives: Behavioral: Postoperative Regret Reduction through Immediate Quality of Life Intervention
Only the patients' postoperative regret levels and quality of life scores will be collected.No interventionOnly the patients' postoperative regret levels and quality of life scores will be collected, without any additional interventions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clarifying the impact of immediate intervention on patients' postoperative regret psychology.

    Over a 12-month period after the start of the study, observe the declining trend of regret scores in patients who received immediate intervention compared to the control group.

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

Secondary outcomes (1)
  1. Main Factors Affecting Postoperative Regret in Low-Risk PTC Patients

    Over a 12-month period after the start of the study, evaluate patients' quality of life in different aspects following thyroid cancer surgery at each time point using the thyroid cancer-specific Quality of Life (QoL) scale.

    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.

  1. First posted3 Feb 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

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
The REDCap randomization module will be used, and block randomization will be computer-generated with block sizes of 6 and 9, in a 1:1 ratio, to allocate patients to either the intervention or control group. The allocation sequence will be concealed, and the randomized results will be extracted by an independent data collection team. If intervention group patients need to complete the QoL scale, after completion, the doctor from the department corresponding to the factor with the highest score (i.e., the factor most closely related to the patient's regret state) will receive an SMS notification and will be required to contact the patient by phone or SMS within 24 hours to provide the intervention. If contact is not established within 24 hours of the intervention phase, the research participant will call the patient up to two times to clarify the reason.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06804863
Sponsor's protocol ID
WestChinaH20220423
Status last verified
Jan 2025
First submitted
27 Jan 2025
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Postoperative Regret Reduction through Immediate Quality of Life Intervention in people with Thyroid Cancer and Regret, 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 4 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: opening soon, as of the sponsor's last update on 3 Feb 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?

Clarifying the impact of immediate intervention on patients' postoperative regret psychology. (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 3 Feb 2025.

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