Regret Emotion After Thyroidectomy in Low-Risk Papillary Thyroid Cancer

January 27, 2025 updated by: Xinyi Wang, West China Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

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
        • West China Hospital
        • Contact:
        • Contact:
          • Ziyang Ye, Dr
          • Phone Number: 86-16605758778
        • Sub-Investigator:
          • Ziyang Ye, Dr

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:

  1. Patients with low-risk papillary thyroid cancer without lymph node metastasis who have undergone thyroid surgery,
  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.

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
Experimental: Intervening in patients with postoperative regret emotion.
For the worst postoperative quality of life factors reported by patients, specialized doctors will provide immediate guidance and management via SMS or phone.
Behavioral: Postoperative Regret Reduction through Immediate Quality of Life Intervention
Immediate intervention of the major impaired quality of life factors postoperatively to reduce patients' postoperative regret.
No Intervention: Only the patients' postoperative regret levels and quality of life scores will be collected.
Only the patients' postoperative regret levels and quality of life scores will be collected, without any additional interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clarifying the impact of immediate intervention on patients' postoperative regret psychology.
Time Frame: From enrollment to the end of follow-up at 12 months
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.
From enrollment to the end of follow-up at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Factors Affecting Postoperative Regret in Low-Risk PTC Patients
Time Frame: From enrollment to the end of follow-up at 12 months
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.
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 (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 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 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaH20220423

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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