Clinical trial NCT02398721: Study on HRQOL and Cost-effectiveness Analysis in Management of Patients With <2cm Thyroid Nodules
Official title: A Prospective Randomized Study on Health-related Quality of Life of Patients With Incidental Small (<2cm) Asymptomatic Thyroid Nodules and Cost-effectiveness Analysis in Managing Small Incidental Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodules
Keywords: FNAC
Small Incidental Thyroid Nodules
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Ideally randomized controlled trials should be carried out to compare the cost-effectiveness between FNAC and watchful waiting but such studies are very difficult to conduct in practice because they require following up very large number of subjects for a long period of time.

The aims are to determine the health-related quality of life (HRQOL) and HRQOL preference (utility) of patients undergoing watchful observation (no FNAC) and routine FNAC, and to determine the cost-effectiveness of two strategies in managing small incidental thyroid nodules for the Chinese population in Hong Kong.


Eligibility criteria: Inclusion Criteria:

* Aged 18 or above
* Have life expectancy of at least 6 months
* Have an incidental nodule which measures between 1.0 to 2.0cm in the largest dimension on ultrasound guidance (USG) and has benign ultrasonographic features such as spongiform or honeycomb appearance, purely-cystic, egg shell type calcification, iso-echoic or hyper-echoic in relation to the rest of the thyroid tissue and peripheral vascularity on Doppler USG. For subjects with more than one nodule on USG, provided that the other nodules are not \>2.0cm or have suspicious features (see below), they will still be eligible.
* Normal thyroid function (both serum thyroid-stimulating hormone (TSH) and free T4 levels within normal range)
* Given consent to take part in the study

Exclusion Criteria:

* Have suspicious ultrasonographic features such as microcalcifications, marked hypoechogenicity, irregular margins and / or taller than wide and intranodular vascularity on transverse view on Doppler USG that warrant a FNAC
* Nodule size \> 2.0cm
* Insisting or refusing FNAC or surgical intervention despite medical reassurance
* Inability to understand or communicate in Cantonese or Chinese
* Significant cognitive impairment judged by the doctor to be unable to answer the questionnaire
* Too ill to carry out interview
* Refusal to give consent

Primary outcomes:
measure: The measurement of HRQoL by SF-6D Health Survey
timeFrame: Two years
Secondary outcomes:
measure: The effectiveness of managing small incidental thyroid nodules and treatment effect on the HRQOL of patients with thyroid carcinoma
timeFrame: Two years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References:
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citation: Wong CKH, Liu X, Lang BHH. Cost-effectiveness of fine-needle aspiration cytology (FNAC) and watchful observation for incidental thyroid nodules. J Endocrinol Invest. 2020 Nov;43(11):1645-1654. doi: 10.1007/s40618-020-01254-0. Epub 2020 Apr 19.
citation: Wong CKH, Lang BHH. A randomized trial comparing health-related quality-of-life and utility measures between routine fine-needle aspiration cytology (FNAC) and surveillance alone in patients with thyroid incidentaloma measuring 1-2 cm. Endocrine. 2020 Feb;67(2):397-405. doi: 10.1007/s12020-019-02129-y. Epub 2019 Nov 18.
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