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

Primary Purpose

Thyroid Nodules

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Fine Needle Aspiration Cytology
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Thyroid Nodules focused on measuring FNAC, Small Incidental Thyroid Nodules

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

FNAC

No FNAC

Arm Description

patients will then be randomized routine FNAC strategy

patients will be randomized to watchful observation strategy (no FNAC)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
March 20, 2015
Last Updated
May 1, 2018
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02398721
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 31, 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodules
Keywords
FNAC, Small Incidental Thyroid Nodules

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FNAC
Arm Type
Other
Arm Description
patients will then be randomized routine FNAC strategy
Arm Title
No FNAC
Arm Type
No Intervention
Arm Description
patients will be randomized to watchful observation strategy (no FNAC)
Intervention Type
Other
Intervention Name(s)
Fine Needle Aspiration Cytology
Other Intervention Name(s)
FNAC
Primary Outcome Measure Information:
Title
The measurement of HRQoL by SF-6D Health Survey
Description
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)
Time Frame
Two years
Secondary Outcome Measure Information:
Title
The effectiveness of managing small incidental thyroid nodules and treatment effect on the HRQOL of patients with thyroid carcinoma
Description
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.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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

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