Regret Emotion After Thyroidectomy in Low-Risk Papillary Thyroid Cancer

NCT ID: NCT06804863

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-05-30

Brief 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 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.

Conditions

Thyroid Cancer; Regret

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Postoperative Regret Reduction through Immediate Quality of Life Intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xinyi Wang

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital

Chengdu, Sichuan, China

Countries

China

Central Contacts

Jianyong Lei, Md

Role: CONTACT

leijianyong@scu.edu.cn

86-19983137992

Facility Contacts

Jianyong Lei, MD

Role: primary

leijianyong@scu.edu.cn

86-19983137992

Ziyang Ye, Dr

Role: backup

86-16605758778

Other Identifiers

WestChinaH20220423

Identifier Type: -

Identifier Source: org_study_id