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

Thyroid Nodules Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398721
• Other study ID #: UW 14-500
• Status: Completed
• Phase: N/A
• Start date: March 31, 2015
• Est. completion date: February 2018

Study information

• Verified date: May 2018
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: February 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule
• Thyroid Nodules

Intervention

Other:
• Fine Needle Aspiration Cytology

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (11)

American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer, Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009 Nov;19(11):1167-214. doi: 10.1089/thy.2009.0110. Erratum in: Thyroid. 2010 Jun;20(6):674-5. Thyroid. 2010 Aug;20(8):942. Hauger, Bryan R [corrected to Haugen, Bryan R]. — View Citation

Bonavita JA, Mayo J, Babb J, Bennett G, Oweity T, Macari M, Yee J. Pattern recognition of benign nodules at ultrasound of the thyroid: which nodules can be left alone? AJR Am J Roentgenol. 2009 Jul;193(1):207-13. doi: 10.2214/AJR.08.1820. — View Citation

Ito Y, Miyauchi A, Inoue H, Fukushima M, Kihara M, Higashiyama T, Tomoda C, Takamura Y, Kobayashi K, Miya A. An observational trial for papillary thyroid microcarcinoma in Japanese patients. World J Surg. 2010 Jan;34(1):28-35. doi: 10.1007/s00268-009-0303-0. — View Citation

Mazzaferri EL. Management of a solitary thyroid nodule. N Engl J Med. 1993 Feb 25;328(8):553-9. Review. — View Citation

McLeod DS, Sawka AM, Cooper DS. Controversies in primary treatment of low-risk papillary thyroid cancer. Lancet. 2013 Mar 23;381(9871):1046-57. doi: 10.1016/S0140-6736(12)62205-3. Epub 2013 Mar 22. Review. — View Citation

Mehanna HM, Jain A, Morton RP, Watkinson J, Shaha A. Investigating the thyroid nodule. BMJ. 2009 Mar 13;338:b733. doi: 10.1136/bmj.b733. Review. — View Citation

Moon WJ, Baek JH, Jung SL, Kim DW, Kim EK, Kim JY, Kwak JY, Lee JH, Lee JH, Lee YH, Na DG, Park JS, Park SW; Korean Society of Thyroid Radiology (KSThR); Korean Society of Radiology. Ultrasonography and the ultrasound-based management of thyroid nodules: consensus statement and recommendations. Korean J Radiol. 2011 Jan-Feb;12(1):1-14. doi: 10.3348/kjr.2011.12.1.1. Epub 2011 Jan 3. Review. — View Citation

Pacini F. Management of papillary thyroid microcarcinoma: primum non nocere! J Clin Endocrinol Metab. 2013 Apr;98(4):1391-3. doi: 10.1210/jc.2013-1634. — View Citation

Reiners C, Wegscheider K, Schicha H, Theissen P, Vaupel R, Wrbitzky R, Schumm-Draeger PM. Prevalence of thyroid disorders in the working population of Germany: ultrasonography screening in 96,278 unselected employees. Thyroid. 2004 Nov;14(11):926-32. — View Citation

Sosa JA, Hanna JW, Robinson KA, Lanman RB. Increases in thyroid nodule fine-needle aspirations, operations, and diagnoses of thyroid cancer in the United States. Surgery. 2013 Dec;154(6):1420-6; discussion 1426-7. doi: 10.1016/j.surg.2013.07.006. Epub 2013 Oct 2. — View Citation

Van den Bruel A, Francart J, Dubois C, Adam M, Vlayen J, De Schutter H, Stordeur S, Decallonne B. Regional variation in thyroid cancer incidence in Belgium is associated with variation in thyroid imaging and thyroid disease management. J Clin Endocrinol Metab. 2013 Oct;98(10):4063-71. doi: 10.1210/jc.2013-1705. Epub 2013 Aug 21. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurement of HRQoL by SF-6D Health Survey	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)	Two years
Secondary	The effectiveness of managing small incidental thyroid nodules and treatment effect on the HRQOL of patients with thyroid carcinoma	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.	Two years