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

September 22, 2024 updated by: Ming-an Yu
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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Frienship Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

patients with thyroid nodules before and after treatments

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
thyroidectomy
patients with thyroid nodules who undergo surgical resection
Procedure: thyroidectomy
surgical resection of thyroid nodules
thermal ablation
patients with thyroid nodules who undergo thermal ablation
Procedure: thermal ablation
thermal ablation including microwave ablation, radiofrequency ablation of thyroid nodules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QoL), as a methodologically developed questionnaire, was used to assess thyroid-specific symptoms in thyroid cancer survivors. The questionnaire consists of seven symptom scales (neuromuscular, voice, concentration, sympathetic, throat/mouth, psychological and sensory problems) and six single items (problems with scar, felt chilly, tingling hands/feet, gained weight, headache, less interest in sex), with a time frame of the previous week (except for less interest in sex item, which is four weeks), and each item is scored on a four-point response scale ranging from 1, "not at all", to 4, "very much". Scores were linearly transformed to a 0-100 scale. A higher score on this scale means more symptoms and complaints.
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
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was adopted as a valid measurement of quality of life for cancer patients. It consists of 5 functional scales , 3 symptom scales, 6 single-item common symptom, and global health status (GHS) subscales. The time frame of the questions is the previous week, and each item is scored on a four-point response scale ranging from 1 to 4, except the global status scale, which is scored on a seven-point modified linear analog scale ranging from 1, "very poor" to 7, "excellent". After linear transformation, all scales and single item measures range in score from 0-100. A higher score on the functional scales and global status scale means a better level of functioning and HRQoL, whereas a a higher score on the symptom scales and single item corresponds to more discomfort and complaints.
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 Hospital Anxiety and Depression Scale consists of 14 items measuring symptom severity on a scale of 0-3 with subscales for anxiety (HADS_A) and depression (HADS_D), and a range of possible scores for each subscale of 0-21. Cut-off scores of 8+ for both subscales demonstrate the optimal balance between sensitivity and specificity for identifying cases of anxiety disorders and depression, with sensitivity and specificity of approximately .8 for both subscales.
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
The functional assessment of chronic illness therapy-spiritual well-being scale consists of 12 items formatted in a five-point Likert scale ranging from 0 = not at all to 4 = very much, with the exception of two negatively stated items (4 and 8) coded in a reverse manner. The responses to the self-reported items refer to a 7-day recall period. The scores are added to generate a total score ranging from 0 to 48. With the highest scores representing better spiritual wellbeing.
before treatment and 1month, 6months, and 12 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum thyroid hormone
Time Frame: before treatment and 1month, 6months, and 12 months after treatment
changes in serum thyroid hormone
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
Percent Volume Changes of Nodules: ((Volume (baseline)- Volume (*m*))/Volume (baseline))*100
before treatment and 1month, 6months, and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ming-an Yu

Investigators

  • Study Chair: ming'an yu, MD, China-JapanFriendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17010406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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