Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Manuel Sureda, MD | Plataforma de Oncología. Hospital Quironsalud Torrevieja | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Quironsalud Torrevieja | Torrevieja | Spain |
Not provided
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D013959 | Thyroid Diseases |