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

September 22, 2021 updated by: Manuel Sureda Gonzalez, Quironsalud

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Torrevieja, Spain
        • Hospital Quironsalud Torrevieja

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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].
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).
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].
Through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quironsalud

Investigators

  • Study Chair: Manuel Sureda, MD, Plataforma de Oncología. Hospital Quironsalud Torrevieja

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

September 30, 2014

Study Completion (Actual)

March 31, 2015

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COUNTHY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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