Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-12
Brief Title:
The Effect of a Psychosomatic Symptom Intervention Program on the Primary Treatment of Differentiated Thyroid Cancer
Sponsor:
Harbin Medical University
Organization:
Harbin Medical University
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dear SirMadam
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 Participants 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
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 Participants 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 72004047 | OTHER_GRANT | None | None |
| JFCX202303 | OTHER_GRANT | None | None |
| YJSCX2023-295HYD | OTHER_GRANT | Postgraduate Research Practice Innovation Program of Harbin Medical University | None |