HRQOL in Locally Advanced Thyroid Carcinoma

Study Overview
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Brief Summary
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The purpose of this study was to explore the changes of health-related quality of life (HRQOL) in patients with locally advanced thyroid cancer (LATC) receiving TKI drugs (anlotinib, lenvatinib, etc.).

Detailed Description
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Surgical resection is the cornerstone of treatment for thyroid cancer. However, some patients present with locally advanced disease at the time of diagnosis, and they are not eligible for radical resection. Another patients still had the risk of recurrence after surgery, endocrine therapy and iodine-131 treatment. Tyrosine kinase inhibitors (TKI) have been proved to be effective in thyroid cancer patients. However, it was still unclear whether TKI drugs had influence on the HRQOL of LATC patients. The purpose of this study was to explore the changes of health-related quality of life (HRQOL) in patients with locally advanced thyroid cancer (LATC) receiving TKI drugs (anlotinib, lenvatinib, etc.).Participants enroll the study after informed consent, and quality of life will be assessed using quality of life questionnaires EORTC QLQ C30, and EORTC THY 47 before surgery, and 1,3,6 and 12 months after treatment.

Official Title
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Health-related Quality of Life of Patients With Locally Advanced Thyroid Cancer Receiving Targeted Therapy

Conditions
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Thyroid Cancer, Tyrosine Kinase Inhibitor, Health Related Quality of Life

Intervention / Treatment
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* Drug: Tyrosine kinase inhibitor drugs.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age (18-70 year old) Diagnosis of locally advanced thyroid cancer Patient receiving TKI drugs. Exclusion Criteria: pregnancy or breastfeeding women; history of other malignant diseases, unstable angina, myocardial infarction, cerebral infarction or cerebral hemorrhage within 6 months; (3) patients missing questionnaires greater than 3 times.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TKI group<br>patients with LATC receiving Tyrosine kinase inhibitor drugs. | Drug: Tyrosine kinase inhibitor drugs.<br>* TKI drugs were used at least 8 weeks. Imaging exam would be taken every four weeks.<br>* Other names: TKI treatment;|
| Controlled group<br>patients with LATC receiving other treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the global status of QLQ C30 questionnaire | Change in global HRQOL score between baseline and at 12 months after treatment. A change of more than 10% is set as a limit for a significant change | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adversed events of TKI. | all TKI-related adversed events during and after the treatment of TKI. | 1 year | 
| Change in fatigue score | Change in fatigue score between start and at 12 months after thyroid treatment. A change of more than 10% is set as a limit for a significant change. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRQOL, thyroid cancer, targeted therapy, Tyrosine kinase inhibitor