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

NCT05054634 | Completed

• 1 other identifier: COUNTHY
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Keywords

cancer; oncology; psycho-oncology; psychotherapy; thyroid cancer; radioisotope therapy; quality of life

Outcome Measures

Primary Outcomes (3)

• Anxiety and depression of patients with DTC (Differentiated Thyroid Carcinoma) after a PIBC (Psycho-oncological intervention based on Counselling).

  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.

  Through study completion, an average of 2 months

• Quality of Life of patients with DTC (Differentiated Thyroid Carcinoma) after a PIBC (Psycho-oncological intervention based on Counselling).

  The Quality of Life was measured through the SF-36 questionnaire \[Vilagut G et al 2005, Molina RT 2005, Martin M 2004\].

  Through study completion, an average of 2 months

• Mood, perceived well-being and emotional impact of patients with DTC (Differentiated Thyroid Carcinoma) after a PIBC (Psycho-oncological intervention based on Counselling).

  Those variables were measured through the PGWBI of Dupuy \[Vilagut G et al 2005, Molina RT 2005, Martin M 2004\].

  Through study completion, an average of 2 months

Study Arms (2)

Experimental Group (EG)

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.

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

Control Group (CG)

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.

Interventions

Psycho-oncological Intervention Based on Counselling (PIBC) BEHAVIORAL

Patients in EG received a psycho-oncological intervention based on Counselling (PIBC) following the scheme proposed by Arranz and Cancio in addition to the standard treatment. The evolution of anxiety and depression was evaluated using Hospital Anxiety and Depression Scale (HADS). The aim of the study was to evaluate the effectiveness of a PIBC in reducing anxiety and depression of patients with DTC. Other QoL relevant items were also evaluated using the Short Form-36 Health Survey (SF-36) and Psychological General Well-Being Index (PGWBI) scales.

Experimental Group (EG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• years or over
• Obtaining informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Quironsalud: lead

Study Sites (1)

Hospital Quironsalud Torrevieja

Torrevieja, Spain

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Manuel Sureda, MD

  Plataforma de Oncología. Hospital Quironsalud Torrevieja

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 23, 2021
• Study Start: June 1, 2013
• Primary Completion: September 30, 2014
• Study Completion: March 31, 2015
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

ES (1)