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The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients

Primary Purpose

Thyroid Cancer, Distress, Depression

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Comthyroid
Synthroid
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient who need thyroid hormone replacement therapy after total thyroidectomy for thyroid cancer
  2. HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, or MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4
  3. Patient who maintain TSH recommendation range for TSH suppression according to ATA guidelines

Exclusion Criteria:

  1. < 19 or ≥ 70 years old
  2. Communication difficulties or inability to complete the necessary investigations and questionnaires
  3. Inability to understand purpose of the study or disagree of participation
  4. Past history of psychiatric treatment or diagnosis
  5. Lactation or pregnancy
  6. Past medical history of other cancer diagnosis or treatment
  7. Any of severe comorbid medical conditions according to ASA score ≥ 3

Sites / Locations

  • Dong sik Bae
  • Dongsik Bae

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

T4/T3 combination replacement

T4 mono replacement

Arm Description

Comthyroid

Synthroid

Outcomes

Primary Outcome Measures

Psychological distress (depression or anxiety) assessed with HADS
Change from baseline HADS total score at 24 weeks
Fatigue assessed with MDASI-F
Change from baseline MDASI-F score at 24 weeks

Secondary Outcome Measures

Depression assessed with BDI
Change from baseline BDI total score at 24 weeks
Anxiety assessed with BAI
Change from baseline BAI total score at 24 weeks
Fatigue assessed with BFI
Change from baseline BFI total score at 24 weeks
Response rate using BDI
improvement of depression sx. ≥ 50%
Response rate using BAI
improvement of anxiety sx. ≥ 50%
Response rate using BFI
improvement of fatigue sx. ≥ 50%
Remisssion rate using BDI
Remission rate using BAI
Remission rate using BFI

Full Information

First Posted
January 10, 2017
Last Updated
February 20, 2019
Sponsor
Inje University
Collaborators
Dongnam Institute of Radiological & Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03024151
Brief Title
The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients
Official Title
The Effects of T4 Mono Replacement Versus T4/T3 Combination Replacement on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients; Prospective, Randomized, Double Blind, T4 Comparative Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
Collaborators
Dongnam Institute of Radiological & Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this research is to compare the effects on psychological distress between T4 mono replacement group and T4/T3 combination replacement group after total thyroidectomy in thyroid cancer patients. Subjects: Psychologically distressed patients, such as depression, anxiety, and fatigue patient after total thyroidectomy with thyroid cancer are considered for participation. Screening of distress after total thyroidectomy is used HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, and MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4 for fatigue. Randomization: Using the table of random sampling numbers, patients assign to T4 mono replacement group or T4/T3 combination replacement group. Evaluation for distress: Assessment will be made baseline, 4 weeks, 12 weeks and 24 weeks to investigate change of psychological distress (depression, anxiety, and fatigue). Level of distress after thyroidectomy will determine using Hospital Anxiety and Depression Scale (HADS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) for depression or anxiety, and Brief Fatigue Inventory (BFI) for fatigue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Distress, Depression, Anxiety, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T4/T3 combination replacement
Arm Type
Active Comparator
Arm Description
Comthyroid
Arm Title
T4 mono replacement
Arm Type
Active Comparator
Arm Description
Synthroid
Intervention Type
Drug
Intervention Name(s)
Comthyroid
Intervention Description
T4/T3 combination replacement
Intervention Type
Drug
Intervention Name(s)
Synthroid
Intervention Description
T4 mono replacement
Primary Outcome Measure Information:
Title
Psychological distress (depression or anxiety) assessed with HADS
Description
Change from baseline HADS total score at 24 weeks
Time Frame
baseline, 24 weeks
Title
Fatigue assessed with MDASI-F
Description
Change from baseline MDASI-F score at 24 weeks
Time Frame
baseline, 24 weeks
Secondary Outcome Measure Information:
Title
Depression assessed with BDI
Description
Change from baseline BDI total score at 24 weeks
Time Frame
baseline, 4, 12, 24 weeks
Title
Anxiety assessed with BAI
Description
Change from baseline BAI total score at 24 weeks
Time Frame
baseline, 4, 12, 24 weeks
Title
Fatigue assessed with BFI
Description
Change from baseline BFI total score at 24 weeks
Time Frame
baseline, 4, 12, 24 weeks
Title
Response rate using BDI
Description
improvement of depression sx. ≥ 50%
Time Frame
baseline, 4, 12, 24 weeks
Title
Response rate using BAI
Description
improvement of anxiety sx. ≥ 50%
Time Frame
baseline, 4, 12, 24 weeks
Title
Response rate using BFI
Description
improvement of fatigue sx. ≥ 50%
Time Frame
baseline, 4, 12, 24 weeks
Title
Remisssion rate using BDI
Time Frame
baseline, 4, 12, 24 weeks
Title
Remission rate using BAI
Time Frame
baseline, 4, 12, 24 weeks
Title
Remission rate using BFI
Time Frame
baseline, 4, 12, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient who need thyroid hormone replacement therapy after total thyroidectomy for thyroid cancer HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, or MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4 Patient who maintain TSH recommendation range for TSH suppression according to ATA guidelines Exclusion Criteria: < 19 or ≥ 70 years old Communication difficulties or inability to complete the necessary investigations and questionnaires Inability to understand purpose of the study or disagree of participation Past history of psychiatric treatment or diagnosis Lactation or pregnancy Past medical history of other cancer diagnosis or treatment Any of severe comorbid medical conditions according to ASA score ≥ 3
Facility Information:
Facility Name
Dong sik Bae
City
Busan
Country
Korea, Republic of
Facility Name
Dongsik Bae
City
Busan
Country
Korea, Republic of

12. IPD Sharing Statement

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The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients

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