Clinical trial NCT06610604: Health-Related Quality of Life and Emotions in Patients with Thyroid Nodules
Official title: Health-Related Quality of Life and Emotions in Patients with Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Nodule
Keywords: quality of life
anxiety
depression
spiritual health
thermal ablation
microwave ablation
thyroid nodules
papillary thyroid carcinoma
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with thyroid nodules before and after treatments

Brief summary: 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.

Detailed description: 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\&amp;#39; QoL and emotional well-being before and after treatment.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The Thyroid Cancer-Specific Quality of Life Questionnaire to assess the thyroid-specific quality of life
timeFrame: before treatment and 1month, 6months, and 12 months after treatment
measure: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire to assess the general quality of life
timeFrame: before treatment and 1month, 6months, and 12 months after treatment
measure: Hospital Anxiety and Depression Scale to assess the emotional status
timeFrame: before treatment and 1month, 6months, and 12 months after treatment
measure: The functional assessment of chronic illness therapy-spiritual well-being questionnaire to assess spiritual well-being
timeFrame: before treatment and 1month, 6months, and 12 months after treatment
Secondary outcomes:
measure: serum thyroid hormone
timeFrame: before treatment and 1month, 6months, and 12 months after treatment
measure: Percent Volume Changes of Nodules
timeFrame: before treatment and 1month, 6months, and 12 months after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Frienship Hospital
state: Beijing
Study officials:
affiliation: China-JapanFriendship Hospital
name: ming'an yu, MD
role: STUDY_CHAIR
References: