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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 314
- Locations
- 1
- Primary Endpoint
- The measurement of HRQoL by SF-6D Health Survey
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
No FNAC
patients will be randomized to watchful observation strategy (no FNAC)
FNAC
patients will then be randomized routine FNAC strategy
Intervention: Fine Needle Aspiration Cytology (Other)
Outcomes
Primary Outcomes
The measurement of HRQoL by SF-6D Health Survey
Time Frame: Two years
Health-related Quality of Life (HRQoL) preference value measured by The Chinese (HK) SF-6D Health Survey will be calculated by the Hong Kong population specific algorithm. It ranges from 0 (dead) to 1 (perfect health)
Secondary Outcomes
- The effectiveness of managing small incidental thyroid nodules and treatment effect on the HRQOL of patients with thyroid carcinoma(Two years)
Investigators
Dr. Lang Hung Hin, Brian
Associate Professor
The University of Hong Kong