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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorMing-an Yu

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Clinical diagnosis of benign thyroid nodules or papillary thyroid carcinoma ;

underwent microwave ablation or thyroidectomy;

ability to understand and cooperate with the survey

Disqualifiers

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 population

patients with thyroid nodules before and after treatments

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • thermal ablation

    Procedure/Surgery

    thermal ablation including microwave ablation, radiofrequency ablation of thyroid nodules

  • thyroidectomy

    Procedure/Surgery

    surgical resection of thyroid nodules

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: thyroidectomy1 intervention
Group B: thermal ablation1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
before treatment and 1month, 6months, and 12 months after treatment
2

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.

Time frame
before treatment and 1month, 6months, and 12 months after treatment
3

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.

Time frame
before treatment and 1month, 6months, and 12 months after treatment
4

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.

Time frame
before treatment and 1month, 6months, and 12 months after treatment

Secondary outcomes

1

serum thyroid hormone

changes in serum thyroid hormone

Time frame
before treatment and 1month, 6months, and 12 months after treatment
2

Percent Volume Changes of Nodules

Percent Volume Changes of Nodules: ((Volume (baseline)- Volume (\*m\*))/Volume (baseline))\*100

Time frame
before treatment and 1month, 6months, and 12 months after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ming-an Yu

Lead sponsor

China-Japan Friendship Hospital

Sponsor institution