Thyroid NoduleNCT06610604
Health-Related Quality of Life and Emotions in Patients with Thyroid Nodules
An observational study of Thyroid Nodule, run by Ming-an Yu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- thermal ablation and thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with thyroid nodules before and after treatments
Who may be able to join
- Clinical diagnosis of benign thyroid nodules or papillary thyroid carcinoma ;
- underwent microwave ablation or thyroidectomy;
- ability to understand and cooperate with the survey
Who cannot join
- serious primary diseases in the liver, kidney, hematopoietic, or endocrine systems；
- a history of mental illness, personality disorders, cognitive impairments, or organic brain disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Frienship Hospital
Beijing, Beijing Municipality, 100029
ming'an yu, MD, 84205756, yma301@163.com
yan li, B.S, 84205756, 497059493@QQ.COM
About this study
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.
Read the 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.
- Conditions
- Thyroid Nodule
- Being tested
- thermal ablation, thyroidectomy
- Keywords
- quality of life, anxiety, depression, spiritual health, thermal ablation, microwave ablation, thyroid nodules, papillary thyroid carcinoma
- Medical subject headings
- Thyroid Nodule, Anxiety Disorders, Depression, Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal ablationProcedure or surgery
thermal ablation including microwave ablation, radiofrequency ablation of thyroid nodules
thyroidectomyProcedure or surgery
surgical resection of thyroid nodules
| Study group | Role | What they receive |
|---|---|---|
| thyroidectomy | patients with thyroid nodules who undergo surgical resection Receives: Procedure: thyroidectomy | |
| thermal ablation | patients with thyroid nodules who undergo thermal ablation Receives: Procedure: thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Thyroid Cancer-Specific Quality of Life Questionnaire to assess the thyroid-specific quality of life
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.
Measured: 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
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.
Measured: before treatment and 1month, 6months, and 12 months after treatment
Hospital Anxiety and Depression Scale to assess the emotional status
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.
Measured: 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
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.
Measured: before treatment and 1month, 6months, and 12 months after treatment
Secondary outcomes (2)
serum thyroid hormone
changes in serum thyroid hormone
Measured: before treatment and 1month, 6months, and 12 months after treatment
Percent Volume Changes of Nodules
Percent Volume Changes of Nodules: ((Volume (baseline)- Volume (*m*))/Volume (baseline))*100
Measured: before treatment and 1month, 6months, and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Aug 2022
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming-an Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming-an Yu, China-Japan Friendship Hospital
- Investigators
- ming'an yu, MD, Study chair, China-JapanFriendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610604
- Sponsor's protocol ID
- 17010406
- Status last verified
- Aug 2024
- First submitted
- 2 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life and Emotions in Patients with Thyroid Nodules
- ClinicalTrials.gov ID
- NCT06610604
- Acronym / sponsor ID
- 17010406
- Conditions
- Thyroid Nodule
- Keywords
- quality of life, anxiety, depression, spiritual health, thermal ablation, microwave ablation, thyroid nodules, papillary thyroid carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ming-an YuUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thyroidectomy | – | Procedure: thyroidectomypatients with thyroid nodules who undergo surgical resection |
| thermal ablation | – | Procedure: thermal ablationpatients with thyroid nodules who undergo thermal ablation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with thyroid nodules before and after treatments
Key inclusion criteria (3 listed)
- Clinical diagnosis of benign thyroid nodules or papillary thyroid carcinoma ;
- underwent microwave ablation or thyroidectomy;
- ability to understand and cooperate with the survey
Key exclusion criteria (2 listed)
- serious primary diseases in the liver, kidney, hematopoietic, or endocrine systems；
- a history of mental illness, personality disorders, cognitive impairments, or organic brain disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thermal ablationthermal ablation including microwave ablation, radiofrequency ablation of thyroid nodules | Procedure or surgery | thermal ablation |
| thyroidectomysurgical resection of thyroid nodules | Procedure or surgery | thyroidectomy |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Thyroid Nodule
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Recruiting
Thyroid Artery Embolization for the Treatment of Compressive Goiters.
Thyroid Nodules
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Recruiting
Radiofrequency Ablation Study in LatinX Patients
Thyroid Nodule
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ming'an yu, MD study chair
China-JapanFriendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, run by Ming-an Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ming'an yu, MD (84205756, yma301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.