## Protocol Section
### Identification Module
**NCT ID:** NCT06422702

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

**Official Title:** A Prospective, Randomized, Single-blind Study on the Effects of Psychosomatic Symptom Interventions on Patients With Differentiated Thyroid Cancer During the Initial Treatment Period

#### Organization Study ID Info
**ID:** HMUDQ20231116204
#### Organization
**Class:** OTHER
**Full Name:** Harbin Medical University
#### Secondary ID Infos
**Domain:** National Natural Science Foundation of China
**ID:** 72004047
**Type:** OTHER_GRANT
**Domain:** Fundamental Research Funds for the Provincial Universities，Heilongjiang,China
**ID:** JFCX202303
**Type:** OTHER_GRANT
**Domain:** Postgraduate Research & Practice Innovation Program of Harbin Medical University
**ID:** YJSCX2023-295HYD
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2024-08-22

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-01-22

**Type:** ACTUAL

#### Start Date
**Date:** 2023-08-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Harbin Medical University

#### Responsible Party

**Investigator Affiliation:** Harbin Medical University

**Investigator Full Name:** Shuhua Luo

**Investigator Title:** researcher

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- 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

**Keywords:**

- Differentiated thyroid cancer

- Anxiety

- Depression

- Thyroid stimulating hormone

- Randomized block design

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 84

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Implementation of a psychosomatic symptom intervention with a duration of three months.

**Intervention Names:**

- Other: Psychosomatic Symptoms Intervention

**Label:** intervention group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control group implemented continuity of supportive care based on primary care

**Intervention Names:**

- Other: Extended supportive care

**Label:** control group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- intervention group

**Description:** Psychosomatic symptoms included intervention of negative psychological symptoms and intervention of physical discomfort symptoms.

**Name:** Psychosomatic Symptoms Intervention

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- control group

**Description:** The control group implemented continuity of supportive care based on primary care

**Name:** Extended supportive care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** This study is based on the recommended by 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. First, in patients with a structural incomplete response to therapy, the serum TSH should be maintained below 0.1 mU/L. Secondly, in patients with a biochemical incomplete response to therapy, the serum TSH should be maintained between 0.1 and 0.5 mU/L. In patients with an excellent (clinically and biochemically free of disease) or indeterminate response to therapy, the serum TSH may be kept within the low reference range (0.5-2 mU/L). Finally, in patients who have not undergone remnant ablation, the serum TSH can be allowed to rise to the low reference range (0.5-2 mU/L).

**Measure:** TSH

**Time Frame:** Before the start of the intervention (T0), at the end of the intervention (up to 12 weeks of intervention, i.e., three months postoperatively, T1), and six months after the end of the intervention (i.e., nine months postoperatively, T2).

#### Secondary Outcomes

**Description:** The Hospital Anxiety and Depression Scale (HADS) was used to assess the anxiety and depression levels of DTC patients. The scale was developed by Zigmond in 1983 and is primarily used to assess the anxiety and depression of the subjects over the past month. A total of 14 items were included, comprising an anxiety subscale and a depression subscale, each containing 7 items. According to the frequency of occurrence, the situation is divided into four levels, namely "1 to 4", scored from 0 to 3 points, and the two subscales range from 0 to 21 points. The lowest possible score is 0, while the highest is 42. Higher scores on the scale indicate more severe levels of anxiety and depression.

**Measure:** anxiety and depression

**Time Frame:** Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3).

**Description:** The Chinese version of Strategies Used by People to Promote Health (C-SUPPH) was used to evaluate the self-management efficacy of DTC patients. The scale was developed in 1996, and the Chinese version was revised by Huijuan Qian et al. There were 28 items in total, including 3 dimensions of positive attitude (items 7, 15 to 28), self-decision-making (items 10 to 12) and self-decompression (items 1 to 6, 8, 14). Each item was scored using the Likert 5 scale, with a score of 1 indicating no confidence and a score of 5 indicating very confident. The total score ranged from 28 to 140, ranging from 0 to 55 (low level), from 55 to 112 (medium level), and from \>112 (high level), with higher scores indicating greater confidence in the individual to perform self-care.

**Measure:** Self-management efficacy

**Time Frame:** Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3).

**Description:** The Constant-Murley Shoulder Function Scale (CMS) was used to assess the shoulder joint activity of the two groups. The scale includes two dimensions: subjective evaluation and objective evaluation. Subjective evaluation included pain levels and activities of daily living. Objective evaluation included assessing shoulder range of motion and muscle strength. The lowest score is 0, the highest score is 100, higher scores indicate better shoulder function.

**Measure:** Shoulder function

**Time Frame:** Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3).

### Eligibility Module

**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

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Harbin

**Country:** China

**Facility:** Harbin Medical University

**State:** Heilongjiang

**Zip:** 150000

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-05-01

- Filename: Prot_SAP_ICF_000.pdf

- Has ICF: True

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

- Size: 191154

- Type Abbrev: Prot_SAP_ICF

- Upload Date: 2024-05-15T22:50

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC04

- Name: Neoplasms

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M16718

- Name: Thyroid Diseases

- Relevance: HIGH

- As Found: Thyroid

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M16723

- Name: Thyroid Neoplasms

- Relevance: HIGH

- As Found: Thyroid Cancer

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013964

- Term: Thyroid Neoplasms

- ID: D000013959

- Term: Thyroid Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
