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Completed

NCT Number: NCT05054634

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Quironsalud Torrevieja

Torrevieja, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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].

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

    Time frame: 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].

Sponsors and collaborators

Lead sponsor

Quironsalud

Other

Registry information

Official study title

Psycho-oncological Intervention Through Counselling in Patients With Differentiated Thyroid Cancer in Treatment With Radioiodine: A Non-randomized Controlled Study

Acronym: COUNTHY

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 23, 2021
Registry last updated
Sep 23, 2021

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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