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

Completed

• Conditions: Thyroid Cancer
• Interventions: Behavioral: Psycho-oncological Intervention Based on Counselling (PIBC)

• Registration Number: NCT05054634
• Lead Sponsor: Quironsalud

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-06-01
• Primary Completion: 2014-09-30
• Study Completion: 2015-03-31
• Status Verified: 2021-09
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-22
• Last Update Submitted: 2021-09-22
• Study First Posted: 2021-09-23
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group (EG)	Psycho-oncological Intervention Based on Counselling (PIBC)	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.

Primary Outcome Measures

Name	Time	Method
Quality of Life of patients with DTC (Differentiated Thyroid Carcinoma) after a PIBC (Psycho-oncological intervention based on Counselling).	Through study completion, an average of 2 months	The Quality of Life was measured through the SF-36 questionnaire \[Vilagut G et al 2005, Molina RT 2005, Martin M 2004\].
Mood, perceived well-being and emotional impact of patients with DTC (Differentiated Thyroid Carcinoma) after a PIBC (Psycho-oncological intervention based on Counselling).	Through study completion, an average of 2 months	Those variables were measured through the PGWBI of Dupuy \[Vilagut G et al 2005, Molina RT 2005, Martin M 2004\].
Anxiety and depression of patients with DTC (Differentiated Thyroid Carcinoma) after a PIBC (Psycho-oncological intervention based on Counselling).	Through study completion, an average of 2 months	Research on the effectiveness of psycho-oncological interventions in the last 20 years has been classified according to the phase of the oncological process and to the objectives to be achieved. According to the objectives, the interventions focuses on controlling the symptoms associated with the disease, on improving the emotional state, on improving and recover the functional status of patients and on improving quality of life (QoL).; Anxiety and depression were evaluated through the HADS scale \[Zigmond et al. 1983, Herrmann 1997\]. A minimum goal of 3-point reduction in the HADS scale was considered as an improvement. Effect size measure was calculated with Cohen's d for the difference between EG and CG in the primary outcome variable at post-treatment, for both anxiety and depression.

Trial Locations

Locations (1)

Hospital Quironsalud Torrevieja; 🇪🇸 Torrevieja, Spain