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

NCT06610604 | Recruiting DMC

• 1 other identifier: 17010406
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodule

Keywords

quality of life; anxiety; depression; spiritual health; thermal ablation; microwave ablation; thyroid nodules; papillary thyroid carcinoma

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (2)

• serum thyroid hormone

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

• Percent Volume Changes of Nodules

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

Study Arms (2)

thyroidectomy

patients with thyroid nodules who undergo surgical resection

Procedure: thyroidectomy

thermal ablation

patients with thyroid nodules who undergo thermal ablation

Procedure: thermal ablation

Interventions

thermal ablation PROCEDURE

thermal ablation including microwave ablation, radiofrequency ablation of thyroid nodules

thermal ablation

thyroidectomy PROCEDURE

surgical resection of thyroid nodules

thyroidectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with thyroid nodules before and after treatments

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ming-an Yu: lead

Study Sites (1)

China-Japan Frienship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Anxiety Disorders; Depression; Thyroid Cancer, Papillary

Interventions

Transurethral Resection of Prostate; Thyroidectomy

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Endocrine Surgical Procedures

Study Officials

• ming'an yu, MD

  China-JapanFriendship Hospital

  STUDY CHAIR

Central Study Contacts

ming'an yu, MD

CONTACT

84205756; yma301@163.com

yan li

CONTACT

8420576; 497059493@QQ.COM

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of department of interventional medicine

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 24, 2024
• Study Start: August 1, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)