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Recruiting NCT06610604

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

— Observational Thyroid Nodule

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: thermal ablation, thyroidectomy.
Who it may be relevant to
Registry conditions: Thyroid Nodule. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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\' QoL and emotional well-being before and after treatment.

Interventions

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

Primary outcome measures

  • The Thyroid Cancer-Specific Quality of Life Questionnaire to assess the thyroid-specific quality of life [Time frame: 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 [Time frame: before treatment and 1month, 6months, and 12 months after treatment]
  • Hospital Anxiety and Depression Scale to assess the emotional status [Time frame: 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 [Time frame: before treatment and 1month, 6months, and 12 months after treatment]
Secondary outcome measures (2)
  • serum thyroid hormone [Time frame: before treatment and 1month, 6months, and 12 months after treatment]
  • Percent Volume Changes of Nodules [Time frame: before treatment and 1month, 6months, and 12 months 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • China-Japan Frienship Hospital — Beijing

Identifiers

NCT: NCT06610604 · 17010406

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗