Health-Related Quality of Life and Emotions in Patients with Thyroid Nodules

Обзор

The purpose of this observational research is to evaluate and compare the health-related quality of life and emotional well-being of patients with thyroid nodules before and after treatment. This is a data collection study by allowing investigators to access information generated before and after treatment.

Подробное описание

The incidence of thyroid nodules is rising worldwide. Papillary thyroid carcinoma (PTC), the most common type of thyroid cancer, has a favorable prognosis, with a low mortality rate and over 90% 10-year survival rate. Thyroidectomy is often applied to manage thyroid nodules as a traditional method. However, thermal ablation (TA), including microwave ablation (MWA), radiofrequency ablation (RFA), and laser ablation, has emerged as an alternative option for selected patients with thyroid function. TA methods are effective, safe, feasible, and have litter influence on thyroid function. Patients with thyroid nodules frequently exhibit higher levels of emotional stress compared to the general population. Additionally, health-related quality of life (QoL) has become an important endpoint and a strong predictor of survival time in medical and health research, underscoring the importance of treatments that not only prolong life but also preserve or enhance QoL. Considering the long survival time of patients with thyroid noduls and the similar therapeutic outcomes between surgery and MWA , it is crucial to pay more attention on patients\' QoL and emotional well-being before and after treatment.

Вмешательства

• Процедура thermal ablation
  thermal ablation including microwave ablation, radiofrequency ablation of thyroid nodules
• Процедура thyroidectomy
  surgical resection of thyroid nodules

Первичные конечные точки

• The Thyroid Cancer-Specific Quality of Life Questionnaire to assess the thyroid-specific quality of life [Срок оценки: before treatment and 1month, 6months, and 12 months after treatment]
• the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire to assess the general quality of life [Срок оценки: before treatment and 1month, 6months, and 12 months after treatment]
• Hospital Anxiety and Depression Scale to assess the emotional status [Срок оценки: before treatment and 1month, 6months, and 12 months after treatment]
• The functional assessment of chronic illness therapy-spiritual well-being questionnaire to assess spiritual well-being [Срок оценки: before treatment and 1month, 6months, and 12 months after treatment]

Вторичные конечные точки (2)

• serum thyroid hormone [Срок оценки: before treatment and 1month, 6months, and 12 months after treatment]
• Percent Volume Changes of Nodules [Срок оценки: before treatment and 1month, 6months, and 12 months after treatment]

Критерии участия

Критерии включения

• Clinical diagnosis of benign thyroid nodules or papillary thyroid carcinoma ;
• underwent microwave ablation or thyroidectomy;
• ability to understand and cooperate with the survey

Критерии исключения

• serious primary diseases in the liver, kidney, hematopoietic, or endocrine systems；
• a history of mental illness, personality disorders, cognitive impairments, or organic brain disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• China-Japan Frienship Hospital — Пекин

Идентификаторы

NCT: NCT06610604 · 17010406

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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