Clinical trial NCT03024151: 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
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Cancer
Distress
Depression
Anxiety
Fatigue
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: Dongnam Institute of Radiological & Medical Sciences
First posted: 2017-01-18
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

1. 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.
2. Randomization:

   * Using the table of random sampling numbers, patients assign to T4 mono replacement group or T4/T3 combination replacement group.
3. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Psychological distress (depression or anxiety) assessed with HADS
timeFrame: baseline, 24 weeks
measure: Fatigue assessed with MDASI-F
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: Depression assessed with BDI
timeFrame: baseline, 4, 12, 24 weeks
measure: Anxiety assessed with BAI
timeFrame: baseline, 4, 12, 24 weeks
measure: Fatigue assessed with BFI
timeFrame: baseline, 4, 12, 24 weeks
measure: Response rate using BDI
timeFrame: baseline, 4, 12, 24 weeks
measure: Response rate using BAI
timeFrame: baseline, 4, 12, 24 weeks
measure: Response rate using BFI
timeFrame: baseline, 4, 12, 24 weeks
measure: Remisssion rate using BDI
timeFrame: baseline, 4, 12, 24 weeks
measure: Remission rate using BAI
timeFrame: baseline, 4, 12, 24 weeks
measure: Remission rate using BFI
timeFrame: baseline, 4, 12, 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong sik Bae
city: Busan
country: Korea, Republic of
facility: Dongsik Bae
Study officials:
References: