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Completed

NCT Number: NCT02398721

Study on HRQOL and Cost-effectiveness Analysis in Management of Patients With <2cm Thyroid Nodules

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.

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Key information

Conditions

Thyroid Nodules Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fine Needle Aspiration Cytology

Other

Other names: FNAC

Primary outcomes

  1. 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

  1. The effectiveness of managing small incidental thyroid nodules and treatment effect on the HRQOL of patients with thyroid carcinoma

    Time frame: Two years

    The effectiveness of managing small incidental thyroid nodules is quantified by quality-adjusted life years (QALYs), which will be calculated as the product of average duration of each stage (including no illness) and the SF-6D preference value for that particular health state.

    The direct health care costs of different strategies in managing small incidental thyroid nodules will be estimated using the costs published by the Government Gazette and previous literatures.

    HRQOL measured by the Chinese (Hong Kong) Short Form-12 (SF-12) Health Survey version 2 and FACT-G will be evaluated to identify these major problem of life.

    Health service utilizations of patients with thyroid neoplasm will be surveyed.

    Treatment effect on the HRQOL of patients with thyroid carcinoma will be explored.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Mar 25, 2015
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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