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NCT Number: NCT03024151

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

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.

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Key information

Conditions

Thyroid Cancer Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Distress Endocrine Gland Neoplasms Endocrine System Diseases Fatigue Head and Neck Neoplasms Mental Disorders Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Thyroid Diseases Thyroid Neoplasms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dong sik Bae, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comthyroid

Drug

T4/T3 combination replacement

Synthroid

Drug

T4 mono replacement

Primary outcomes

  1. Psychological distress (depression or anxiety) assessed with HADS

    Time frame: baseline, 24 weeks

    Change from baseline HADS total score at 24 weeks

  2. Fatigue assessed with MDASI-F

    Time frame: baseline, 24 weeks

    Change from baseline MDASI-F score at 24 weeks

Secondary outcomes

  1. Depression assessed with BDI

    Time frame: baseline, 4, 12, 24 weeks

    Change from baseline BDI total score at 24 weeks

  2. Anxiety assessed with BAI

    Time frame: baseline, 4, 12, 24 weeks

    Change from baseline BAI total score at 24 weeks

  3. Fatigue assessed with BFI

    Time frame: baseline, 4, 12, 24 weeks

    Change from baseline BFI total score at 24 weeks

  4. Response rate using BDI

    Time frame: baseline, 4, 12, 24 weeks

    improvement of depression sx. ≥ 50%

  5. Response rate using BAI

    Time frame: baseline, 4, 12, 24 weeks

    improvement of anxiety sx. ≥ 50%

  6. Response rate using BFI

    Time frame: baseline, 4, 12, 24 weeks

    improvement of fatigue sx. ≥ 50%

  7. Remisssion rate using BDI

    Time frame: baseline, 4, 12, 24 weeks

  8. Remission rate using BAI

    Time frame: baseline, 4, 12, 24 weeks

  9. Remission rate using BFI

    Time frame: baseline, 4, 12, 24 weeks

Sponsors and collaborators

Lead sponsor

Inje University

Other

Collaborators

  • Dongnam Institute of Radiological & Medical Sciences

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2017
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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