Clinical trial NCT04936139: Art Therapy Effectiveness in the Level of Anxiety and Depression of Cancer Patients
Official title: Effectiveness of Art Therapy in the Level of Anxiety and Depression of Cancer Patients. Multicentric Random Clinical Trial (ATANDEC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Art Therapy
Depression
Anxiety
Quality of Life
Coping Skills
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
Collaborators: name: Fundació privada Nous Cims
name: Althaia Xarxa Assistencial Universitària de Manresa
First posted: 2021-06-23
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial
Primary purpose: TREATMENT

Brief summary: Having a diagnosis of cancer leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve the emotional well-being is considered.

Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease.

Detailed description: Introduction: The passage of a cancer through a person leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve your emotional well-being is considered.

Research Project Hypothesis: Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease.

Objectives: To evaluate the effectiveness of art therapy in reducing the levels of anxiety and depression in cancer patients, as well as in improving the quality of life and coping strategies.

Methodology: Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial. Eight centers will participate in the study with an N of 423 patients. Patients older than 18 years of age who are diagnosed with cancer at any stage of treatment with the intention of radical treatment or palliative treatment with a life expectancy of more than 12 months will be included. If it is carried out in an online format, the person must have access to the internet. Patients who suffer from a current or previous serious psychological / psychiatric illness or those who have participated in an art therapy program structured in the context of oncological process will be excluded. Patients will be assigned to the control group (they will receive the usual follow-up from the center) or to the intervention group (art therapy program). Patients assigned to the intervention group will participate in an art therapy workshop once a week for 12 weeks, which will be done in person / online depending on the epidemiological situation of covid-19 and the needs of each center, The group will maintain the format (online / face-to-face) with which it has started throughout all the sessions.

Art therapy is a discipline that offers a space to meet with oneself, where one can dialogue with different artistic languages, with the aim of promoting emotional integration and looking for new ways to integrate difficult experiences through creative language.

Assessing anxiety and depression with the HAD scale, coping strategies with the Mini-MAC scale, and WHOQOL-BREF for quality of life will be used. Statistical analysis will be for treatment purposes. IBM SPSS Statistics v.24 and STATA v.14 will be used.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Intention for radical treatment or palliative treatment with a life expectancy of more than 12 months
* Have internet access in case the intervention is done online
* Agree to participate and sign informed consent

Exclusion Criteria:

* Patient with active diagnosis or personal history of severe psychological / psychiatric illness
* Patient who has participated in an art therapy program structured in the context of the oncological process

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HAD scale)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HAD scale)
timeFrame: 6 months
Secondary outcomes:
measure: World Health Organization Quality of Life (WHOQOL-BREF scale)
timeFrame: 3 months
measure: World Health Organization Quality of Life (WHOQOL-BREF scale)
timeFrame: 6 months
measure: Mini-Mental Adjustment to Cancer Scale (MINI-MAC)
timeFrame: 3 months
measure: Mini-Mental Adjustment to Cancer Scale (MINI-MAC)
timeFrame: 6 months
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial Universitària de Manresa
state: Barcelona
Study officials:
affiliation: Fundació Nou Cims
name: Pau Gomes, MsC
role: STUDY_CHAIR
References:
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