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

Condition(s) studied

Investigational drug(s) / intervention(s)

thermal ablation: thermal ablation including microwave ablation, radiofrequency ablation of thyroid nodules

thyroidectomy: surgical resection of thyroid nodules

Study 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.

Eligibility

Primary outcome measure(s)

• The Thyroid Cancer-Specific Quality of Life Questionnaire to assess the thyroid-specific quality of life — 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 — 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 — 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 — 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.

Trial sites (1)

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