The Effect of a Psychosomatic Symptom Intervention Program on the Primary Treatment of Differentiated Thyroid Cancer

Trial Title: The Effect of a Psychosomatic Symptom Intervention Program on the Primary Treatment of Differentiated Thyroid Cancer

NCT ID: NCT06422702

Condition: Pathologically Confirmed Differentiated Thyroid Carcinoma
All Patients Are in the Initial Treatment Phase
Normal Cognitive and Communicative Abilities, Capable of Reading and Understanding Questionnaires in Chinese
Ability to Use a Smartphone
Voluntary Participation in the Study and Signed Informed Consent

Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases

Conditions: Keywords:
Differentiated thyroid cancer
Anxiety
Depression
Thyroid stimulating hormone
Randomized block design

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Single (Participant)

Intervention:

Intervention type: Other
Intervention name: Psychosomatic Symptoms Intervention
Description: Psychosomatic symptoms included intervention of negative psychological symptoms and intervention of physical discomfort symptoms.
Arm group label: intervention group

Intervention type: Other
Intervention name: Extended supportive care
Description: The control group implemented continuity of supportive care based on primary care
Arm group label: control group

Summary: Dear Sir/Madam, You are cordially invited to participate in a clinical study. Before deciding whether to participate, it is important that you understand this study. Please read the following information carefully. If you have fully understood the study, have no further questions, and decide to participate, you will need to sign an informed consent form. 1. Study Background Thyroid cancer is the most common malignant tumor of the endocrine system, with differentiated thyroid cancer (DTC) accounting for over 95% of cases. The initial treatment phase typically refers to the first year after patients undergo surgery, TSH suppression therapy, or radioactive iodine treatment. Studies have found that DTC patients may experience a variety of health-related issues during this stage. For instance, many patients not only suffer from neck discomfort and pain post-surgery but may also face risks of postoperative bleeding, nerve damage, reduced bone density, and other physical complications. They are more susceptible to anxiety, depression, sleep disturbances, and fear of recurrence. These psychological and physical symptoms can affect patients' ability to achieve target TSH levels, which is crucial for their prognosis. Therefore, this study aims to design an intervention plan for the psychosomatic symptoms of DTC patients in the initial treatment phase to improve their physiological discomfort and negative psychological experiences, enhance their self-management efficacy, and promote TSH suppression therapy compliance and overall health. 2. Study Objectives - To explore the impact of the psychosomatic symptom intervention plan on TSH levels, anxiety, depression, and self-management efficacy in patients with differentiated thyroid cancer during the initial treatment phase. - To provide a basis for improving the physical and mental health of DTC patients in the initial treatment phase. 3. Study Design and Process This study targets patients with differentiated thyroid cancer in the initial treatment phase. Participants will be divided into an intervention group and a control group using a block randomization method. The effectiveness of the plan will be tested through a 3-month intervention in a randomized controlled trial. Data collection points are baseline, at the end of the intervention, and 3 months post-intervention. The primary outcome measure is TSH levels, with secondary outcomes including anxiety, depression, and self-management efficacy. This could provide a basis for formulating scientifically sound health service policies, rational allocation and utilization of health resources, reducing the burden of medical services, and establishing a fair and efficient healthcare system. 4. Potential Benefits and Risks We will provide necessary advice for your current concerns and offer information related to differentiated thyroid cancer. Should you experience any discomfort during the study, please provide feedback to the medical staff in the research team promptly. We will dynamically assess your physiological and psychological changes and address them promptly, so there is no need for concern. 5. Handling of Harm The study involves a psychosomatic intervention lasting 12 weeks, with two sessions per week, each approximately 30 minutes. If you have any concerns during the intervention, you may contact us at any time. Our researchers, after various assessments, believe that this study will not harm your physical health. Even if you have signed this informed consent, you still retain all your legal rights. 6. Principles of Privacy and Confidentiality Your personal health information will be stored at Harbin Medical University and may be accessed by researchers, regulatory authorities, and the ethics committee. Any public reports on the results of this study will not disclose your personal identity. We will make every effort to protect your personal privacy within the legally permitted scope. By signing this informed consent, you agree to the use of your personal and health information as described above. 7. Voluntary Principle Participation in this study is entirely voluntary. You may refuse to participate or opt out of the study at any time without any reason. This decision will not affect your future daily life. However, it is hoped that you will complete this study unless there are special reasons. If you decide to withdraw under any circumstances, please inform the researchers. 8. Participant's Responsibilities Once you agree to participate in this study, you should cooperate with the researchers to complete the intervention study and promptly feedback your health recovery status to the researchers during the intervention. 9. Consultation about the Study If you have any questions related to this study, please contact the project leader: Shuhua Luo, at 17382839336.

Criteria for eligibility:
Criteria:
Inclusion criteria: 1. Clinical diagnosis of differentiated thyroid cancer 2. Participants had to be in the initial treatment phase 3. Cognitive and communication skills are normal 4. Can use a smartphone 5. Voluntary participation in the study Exclusion criteria: 1. History of neck or shoulder trauma 2. Coexisting serious heart, brain, or lung diseases 3. History of a major psychological disorder or mental illness 4. Patients taking hypnotics or psychotropic medications 5. have recently participated in a similar intervention or are receiving other psychotherapy

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Locations:

Facility:
Name: Harbin Medical University

Address:
City: Harbin
Zip: 150000
Country: China

Start date: August 1, 2023

Completion date: April 22, 2025

Lead sponsor:
Agency: Harbin Medical University
Agency class: Other

Source: Harbin Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06422702