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A prospective study to assess the usefulness of 3-dimensional thyroid model on the informed consent and understanding of patients prior to thyroid surgery

Status Approved

First Submitted Date

2020/05/25
Registered Date

2020/05/29
Last Updated Date

2020/12/01

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005069
Unique Protocol ID	NCC2019-0256
Public/Brief Title	A study to analysis the usefulness of personalized 3D thyroid model
Scientific Title	A prospective study to assess the usefulness of 3-dimensional thyroid model on the informed consent and understanding of patients prior to thyroid surgery
Acronym	THY3D
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	NCC2019-0256
Approval Date	2019-11-04
Institutional Review Board Name	National Cancer Center Institutional Review Board
Institutional Review Board Address	323, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
Institutional Review Board Telephone	031-920-0425
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Yuh-Seog Jung
Title	Senior Researcher
Telephone	+82-31-920-1685
Affiliation	National Cancer Center
Address	323, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
Contact Person for Public Queries
Name	Jungirl Seok
Title	Clinical Staff
Telephone	+82-31-920-1625
Affiliation	National Cancer Center
Address	323, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
Contact Person for Updating Information
Name	Jungirl Seok
Title	Clinical Staff
Telephone	+82-31-920-1625
Affiliation	National Cancer Center
Address	323, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2020-07-07 Actual
Target Number of Participant	60
Primary Completion Date	2020-12-01 , Actual
Study Completion Date	2020-12-01 , Actual
Name of Study	National Cancer Center
Recruitment Status	Completed
Date of First Enrollment	2020-07-07 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Cancer Center
Organization Type	Medical Institute
Project ID	1810866-2

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	National Cancer Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Background: multimedia-based resources were introduced to help patients in understanding their disease. Recently, the use of 3D-printing in medicine has been increased, it enabled us to explain to a patient using a personalized 3D model. Purpose: To prospectively evaluate the usefulness of 3D models of the thyroid gland for improving patient understanding of thyroid surgery and disease. Subjects included: Patients diagnosed with thyroid cancer or disease who are scheduled for surgery at our institution and who have agreed to a study of thyroid 3D model construction. Intervention: Group A randomized by the Block Randomization method uses a 3D model to describe the surgical consent, and Group B receives a description of the operation using only documentation in a conventional manner. A total of two surveys will be given each at the time of receiving a surgical consent (second outpatient visit) and at the date of admission for surgery. Outcome Measures: Measure questionnaires evaluated at two different time points: (1) general information about the operation, (2) the need for the operation, (3) the risk of the operation, and (4) satisfaction with the explanation. Research hypothesis: There will be an improvement in the understanding of disease, the necessity of risk, the understanding of risk, and overall explanation satisfaction in the group of patients who described surgery through 3D model.

Study Summary Information

Lay Summary

Background: multimedia-based resources were introduced to help patients in understanding their disease. Recently, the use of 3D-printing in medicine has been increased, it enabled us to explain to a patient using a personalized 3D model.
Purpose: To prospectively evaluate the usefulness of 3D models of the thyroid gland for improving patient understanding of thyroid surgery and disease.
Subjects included: Patients diagnosed with thyroid cancer or disease who are scheduled for surgery at our institution and who have agreed to a study of thyroid 3D model construction.
Intervention: Group A randomized by the Block Randomization method uses a 3D model to describe the surgical consent, and Group B receives a description of the operation using only documentation in a conventional manner. A total of two surveys will be given each at the time of receiving a surgical consent (second outpatient visit) and at the date of admission for surgery.
Outcome Measures: Measure questionnaires evaluated at two different time points: (1) general information about the operation, (2) the need for the operation, (3) the risk of the operation, and (4) satisfaction with the explanation.
Research hypothesis: There will be an improvement in the understanding of disease, the necessity of risk, the understanding of risk, and overall explanation satisfaction in the group of patients who described surgery through 3D model.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Others (Tool used to explain to patient)
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	Others
Intervention Description	Group A randomly assigned by the Block Randomization method uses a 3D model when explaining a surgical consent form, and Group B receives a description of the surgery using only a document in a conventional manner.
Number of Arms	2
Arm 1	Arm Label Arm B
	Target Number of Participant 30
	Arm Type No intervention
	Arm Description The second visit after the study consent (first visit) is approved by using the document only in the conventional manner.
Arm 2	Arm Label Arm A
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description On the second visit after the study consent (first visit), a surgical consent is obtained using the 3D model.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C73)Malignant neoplasm of thyroid gland Cancer of Thyroid Thyroid neoplasms
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~70Year
	Description Patients who have been diagnosed with thyroid cancer or disease and are planning to undergo surgery at the research institute, and have consented to the study of thyroid 3D model construction.
Exclusion Criteria	Withdrawal of consent at patient's request
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Degree of understanding of the risk of surgery
Timepoint	Immediately after receiving a written consent and at the time of admission for surgery
Primary Outcome(s) 2
Outcome	Satisfaction with explaining surgery
Timepoint	Immediately after receiving a written consent and at the time of admission for surgery
Primary Outcome(s) 3
Outcome	Degree of understanding of the disease
Timepoint	Immediately after receiving a written consent and at the time of admission for surgery
Primary Outcome(s) 4
Outcome	Degree of understanding of the necessity of surgery
Timepoint	Immediately after receiving a written consent and at the time of admission for surgery
Secondary Outcome(s) 1
Outcome	Changes in survey scores (primary outcomes) at intervals between two questionnaires
Timepoint	At the end of the second questionnaire

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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