Psycho-oncological Intervention Through Counselling in Patients With Differentiated Thyroid Cancer in Treatment With Radioiodine (COUNTHY)

Fresenius

Status: Completed

Conditions: Thyroid Cancer

Treatments: Behavioral: Psycho-oncological Intervention Based on Counselling (PIBC)

Study type: Observational

Funder types: Other

Identifiers

NCT05054634

COUNTHY

Details and patient eligibility

About

Diagnosis and treatment of differentiated thyroid carcinomas cause anxiety and depression. Additionally, these patients suffer hormonal alterations, associated with psychological symptoms (changes in mood, emotional instability, memory loss, etc.). This study aims to evaluate the effectiveness of a psycho-oncological intervention based on Counselling to reduce anxiety and depression related with the treatment in patients with differentiated thyroid carcinomas.

Full description

A non-randomized controlled study, with two groups (experimental, n=37, and control, n=38) and baseline and post-treatment measures was designed. Patients in experimental group received a psycho-oncological intervention based on Counselling in addition to the standard treatment. The independent variable was the assigned group and the dependent one was the evolution of anxiety and depression, analyzed separately, both evaluated using HADS. Other relevant covariables related with quality of life were also analyzed using SF-36 and PGWBI scales.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with DTC (differentiated thyroid carcinoma)
• Initial treatment by total thyroidectomy
• Treatment with RIT after physiological stimulation of thyroid-stimulating hormone (TSH) by suppression of hormone replacement therapy (HRT) for a month
• Fluid Spanish speaker
• 18 years or over
• Obtaining informed consent

Exclusion criteria

• Diagnosis or treatment for psychiatric disorders
• Any type of illness with serious impact in medical condition
• Inability to communicate or to process the information

Trial design

75 participants in 2 patient groups

Experimental Group (EG)

Description:

Patients diagnosed with DTC, treated with thyroidectomy and candidates to RIT to be treated in Nuclear Medicine (NM) Service of Hospital Quirónsalud Torrevieja were considered to be included in the study. They were alternatively assigned to the EG or CG, according to their order of entry.

Treatment:

Behavioral: Psycho-oncological Intervention Based on Counselling (PIBC)

Control Group (CG)

Description:

Patients diagnosed with DTC, treated with thyroidectomy and candidates to RIT to be treated in Nuclear Medicine (NM) Service of Hospital Quirónsalud Torrevieja were considered to be included in the study. They were alternatively assigned to the EG or CG, according to their order of entry.