Clinical trial NCT05054634: Psycho-oncological Intervention Through Counselling in Patients With Differentiated Thyroid Cancer in Treatment With Radioiodine
Official title: Psycho-oncological Intervention Through Counselling in Patients With Differentiated Thyroid Cancer in Treatment With Radioiodine: A Non-randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Keywords: cancer
oncology
psycho-oncology
psychotherapy
thyroid cancer
radioisotope therapy
quality of life
Lead sponsor: Quironsalud
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between June 2013 and September 2014, a total of 75 patients were included in the study, 37 in the EG (Experimental Group) and 38 in the CG (Control Group). No patient declined to be included. No statistically significant differences were observed in sociodemographic characteristics between both groups.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety and depression of patients with DTC (Differentiated Thyroid Carcinoma) after a PIBC (Psycho-oncological intervention based on Counselling).
timeFrame: Through study completion, an average of 2 months
measure: Quality of Life of patients with DTC (Differentiated Thyroid Carcinoma) after a PIBC (Psycho-oncological intervention based on Counselling).
timeFrame: Through study completion, an average of 2 months
measure: Mood, perceived well-being and emotional impact of patients with DTC (Differentiated Thyroid Carcinoma) after a PIBC (Psycho-oncological intervention based on Counselling).
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Torrevieja
country: Spain
facility: Hospital Quironsalud Torrevieja
Study officials:
affiliation: Plataforma de Oncología. Hospital Quironsalud Torrevieja
name: Manuel Sureda, MD
role: STUDY_CHAIR
References: