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Art Therapy Effectiveness in the Level of Anxiety and Depression of Cancer Patients (ATANDEC)

Primary Purpose

Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Art Therapy
Sponsored by
Elisenda Campreciós Suñol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Art Therapy, Depression, Anxiety, Quality of Life, Coping Skills

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Althaia Xarxa Assistencial Universitària de ManresaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Art Therapy

Control group

Arm Description

Patients assigned to the intervention group will participate in 12 weekly group therapy workshop sessions.

Patients assigned to the control group will receive the usual follow-up care of each center provided for the cancer patient and will not perform art therapy workshops. They will be offered the opportunity to participate in the workshops once they have completed their participation in the study, putting them on a waiting list.

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale (HAD scale)
The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.
Hospital Anxiety and Depression Scale (HAD scale)
The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.

Secondary Outcome Measures

World Health Organization Quality of Life (WHOQOL-BREF scale)
The questionnaire contains a total of 26 questions, two global quality of life and general health questions, and one question from each of the 24 facets contained in the WHOQOL-100. It also consists of 4 areas or dimensions: physical health, psychological, social relationships and environment. Each item has 5 ordinary Likert-type response options and the time it takes is two weeks. Higher scores indicate better quality of life
World Health Organization Quality of Life (WHOQOL-BREF scale)
The questionnaire contains a total of 26 questions, two global quality of life and general health questions, and one question from each of the 24 facets contained in the WHOQOL-100. It also consists of 4 areas or dimensions: physical health, psychological, social relationships and environment. Each item has 5 ordinary Likert-type response options and the time it takes is two weeks. Higher scores indicate better quality of life
Mini-Mental Adjustment to Cancer Scale (MINI-MAC)
MINI-MAC is a 29-item instrument on a 4-choice Likert scale that assesses cognitive and behavioral responses to cancer. Differentiate 5 modes of coping: helplessness / hopelessness (ID), anxious worry (PA), cognitive avoidance (EN), fighting spirit (EL), and fatalism (FAE). Results are calculated for each of the examined strategies. Each strategy includes seven relevant statements. Every analysed subscale result range may be from 7 to 28. The higher the score, the stronger the behaviour typical for a given strategy of coping with càncer.
Mini-Mental Adjustment to Cancer Scale (MINI-MAC)
MINI-MAC is a 29-item instrument on a 4-choice Likert scale that assesses cognitive and behavioral responses to cancer. Differentiate 5 modes of coping: helplessness / hopelessness (ID), anxious worry (PA), cognitive avoidance (EN), fighting spirit (EL), and fatalism (FAE). Results are calculated for each of the examined strategies. Each strategy includes seven relevant statements. Every analysed subscale result range may be from 7 to 28. The higher the score, the stronger the behaviour typical for a given strategy of coping with càncer.

Full Information

First Posted
June 14, 2021
Last Updated
October 12, 2022
Sponsor
Elisenda Campreciós Suñol
Collaborators
Fundació privada Nous Cims, Althaia Xarxa Assistencial Universitària de Manresa
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1. Study Identification

Unique Protocol Identification Number
NCT04936139
Brief Title
Art Therapy Effectiveness in the Level of Anxiety and Depression of Cancer Patients
Acronym
ATANDEC
Official Title
Effectiveness of Art Therapy in the Level of Anxiety and Depression of Cancer Patients. Multicentric Random Clinical Trial (ATANDEC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elisenda Campreciós Suñol
Collaborators
Fundació privada Nous Cims, Althaia Xarxa Assistencial Universitària de Manresa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Art Therapy, Depression, Anxiety, Quality of Life, Coping Skills

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Art Therapy
Arm Type
Experimental
Arm Description
Patients assigned to the intervention group will participate in 12 weekly group therapy workshop sessions.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients assigned to the control group will receive the usual follow-up care of each center provided for the cancer patient and will not perform art therapy workshops. They will be offered the opportunity to participate in the workshops once they have completed their participation in the study, putting them on a waiting list.
Intervention Type
Behavioral
Intervention Name(s)
Art Therapy
Intervention Description
During the 12 planned sessions, different artistic disciplines will be used: visual arts, music, play, narrative, dramatization, movement and body expression. Each session is structured in 3 phases: i. A first part of encounter and contextualization, to make contact with oneself, with the art therapist and with the group through a relaxation or meditation activity (35 minutes). ii. A second part, where the session continues with the work of artistic elaboration and production with the different materials and the different artistic languages (50 minutes). iii. A third part where the participants will be invited to make a closing, a moment to welcome and share whoever wishes, the experiences that have been experienced. A dialogue is created between Work-Patient-Art Therapist (35 minutes).
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HAD scale)
Description
The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.
Time Frame
3 months
Title
Hospital Anxiety and Depression Scale (HAD scale)
Description
The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
World Health Organization Quality of Life (WHOQOL-BREF scale)
Description
The questionnaire contains a total of 26 questions, two global quality of life and general health questions, and one question from each of the 24 facets contained in the WHOQOL-100. It also consists of 4 areas or dimensions: physical health, psychological, social relationships and environment. Each item has 5 ordinary Likert-type response options and the time it takes is two weeks. Higher scores indicate better quality of life
Time Frame
3 months
Title
World Health Organization Quality of Life (WHOQOL-BREF scale)
Description
The questionnaire contains a total of 26 questions, two global quality of life and general health questions, and one question from each of the 24 facets contained in the WHOQOL-100. It also consists of 4 areas or dimensions: physical health, psychological, social relationships and environment. Each item has 5 ordinary Likert-type response options and the time it takes is two weeks. Higher scores indicate better quality of life
Time Frame
6 months
Title
Mini-Mental Adjustment to Cancer Scale (MINI-MAC)
Description
MINI-MAC is a 29-item instrument on a 4-choice Likert scale that assesses cognitive and behavioral responses to cancer. Differentiate 5 modes of coping: helplessness / hopelessness (ID), anxious worry (PA), cognitive avoidance (EN), fighting spirit (EL), and fatalism (FAE). Results are calculated for each of the examined strategies. Each strategy includes seven relevant statements. Every analysed subscale result range may be from 7 to 28. The higher the score, the stronger the behaviour typical for a given strategy of coping with càncer.
Time Frame
3 months
Title
Mini-Mental Adjustment to Cancer Scale (MINI-MAC)
Description
MINI-MAC is a 29-item instrument on a 4-choice Likert scale that assesses cognitive and behavioral responses to cancer. Differentiate 5 modes of coping: helplessness / hopelessness (ID), anxious worry (PA), cognitive avoidance (EN), fighting spirit (EL), and fatalism (FAE). Results are calculated for each of the examined strategies. Each strategy includes seven relevant statements. Every analysed subscale result range may be from 7 to 28. The higher the score, the stronger the behaviour typical for a given strategy of coping with càncer.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisenda Campreciós, Bachelor
Phone
+3493 875 93 00
Ext
3140
Email
ecamprec@althaia.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Arnau, PhD
Phone
+3493 875 93 00
Ext
3414
Email
aarnau@althaia.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pau Gomes, MsC
Organizational Affiliation
Fundació Nou Cims
Official's Role
Study Chair
Facility Information:
Facility Name
Althaia Xarxa Assistencial Universitària de Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisenda Campreciós, Bachelor, MSc
Phone
+34 93 875 93 00
Ext
3140
Email
ecamprec@althaia.cat
First Name & Middle Initial & Last Name & Degree
Anna Arnau, PhD
Phone
+34 93 875 9 300
Ext
3414
Email
aarnau@althaia.cat
First Name & Middle Initial & Last Name & Degree
Elisenda Campreciós, Bachelor, MSc
First Name & Middle Initial & Last Name & Degree
Gemma Cuberas, MSc
First Name & Middle Initial & Last Name & Degree
Anna Arnau, PhD
First Name & Middle Initial & Last Name & Degree
Elisabet Roldan, MSc
First Name & Middle Initial & Last Name & Degree
Begoña Mellado
First Name & Middle Initial & Last Name & Degree
Jessica Gonzalez
First Name & Middle Initial & Last Name & Degree
Anna Gonzalez
First Name & Middle Initial & Last Name & Degree
Sara Garcia
First Name & Middle Initial & Last Name & Degree
Anna Rodriguez
First Name & Middle Initial & Last Name & Degree
Sonia Albenia
First Name & Middle Initial & Last Name & Degree
Milagros Barez
First Name & Middle Initial & Last Name & Degree
Maria Marin
First Name & Middle Initial & Last Name & Degree
Carolina Martinez
First Name & Middle Initial & Last Name & Degree
Gemma Riera
First Name & Middle Initial & Last Name & Degree
Imma Brao
First Name & Middle Initial & Last Name & Degree
Laura Puntí
First Name & Middle Initial & Last Name & Degree
Iolanda Pujol
First Name & Middle Initial & Last Name & Degree
Sally Schofield
First Name & Middle Initial & Last Name & Degree
Nereida Jimenez
First Name & Middle Initial & Last Name & Degree
Ana Manzano
First Name & Middle Initial & Last Name & Degree
Sybille Cseri

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24953449
Citation
Archer S, Buxton S, Sheffield D. The effect of creative psychological interventions on psychological outcomes for adult cancer patients: a systematic review of randomised controlled trials. Psychooncology. 2015 Jan;24(1):1-10. doi: 10.1002/pon.3607. Epub 2014 Jun 21.
Results Reference
result
PubMed Identifier
30314577
Citation
Andreu Vaillo Y, Murgui Perez S, Martinez Lopez P, Romero Retes R. Mini-Mental Adjustment to Cancer Scale: Construct validation in Spanish breast cancer patients. J Psychosom Res. 2018 Nov;114:38-44. doi: 10.1016/j.jpsychores.2018.09.004. Epub 2018 Sep 15.
Results Reference
result
PubMed Identifier
16889324
Citation
Oster I, Svensk AC, Magnusson E, Thyme KE, Sjodin M, Astrom S, Lindh J. Art therapy improves coping resources: a randomized, controlled study among women with breast cancer. Palliat Support Care. 2006 Mar;4(1):57-64. doi: 10.1017/s147895150606007x.
Results Reference
result
PubMed Identifier
21990213
Citation
Krikorian A, Limonero JT, Mate J. Suffering and distress at the end-of-life. Psychooncology. 2012 Aug;21(8):799-808. doi: 10.1002/pon.2087. Epub 2011 Oct 11.
Results Reference
result
PubMed Identifier
16288447
Citation
Monti DA, Peterson C, Kunkel EJ, Hauck WW, Pequignot E, Rhodes L, Brainard GC. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer. Psychooncology. 2006 May;15(5):363-73. doi: 10.1002/pon.988.
Results Reference
result
PubMed Identifier
23699646
Citation
Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013 Jun 10;173(11):960-9. doi: 10.1001/jamainternmed.2013.836.
Results Reference
result
PubMed Identifier
19473224
Citation
Svensk AC, Oster I, Thyme KE, Magnusson E, Sjodin M, Eisemann M, Astrom S, Lindh J. Art therapy improves experienced quality of life among women undergoing treatment for breast cancer: a randomized controlled study. Eur J Cancer Care (Engl). 2009 Jan;18(1):69-77. doi: 10.1111/j.1365-2354.2008.00952.x.
Results Reference
result
PubMed Identifier
19619378
Citation
Thyme KE, Sundin EC, Wiberg B, Oster I, Astrom S, Lindh J. Individual brief art therapy can be helpful for women with breast cancer: a randomized controlled clinical study. Palliat Support Care. 2009 Mar;7(1):87-95. doi: 10.1017/S147895150900011X.
Results Reference
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PubMed Identifier
32452121
Citation
Xu L, Cheng P, Wu Y, Zhang J, Zhu J, Cui J, Yu R. The effects of art therapy on anxiety and depression in breast cancer patients: An updated meta-analysis. Eur J Cancer Care (Engl). 2020 Sep;29(5):e13266. doi: 10.1111/ecc.13266. Epub 2020 May 25.
Results Reference
result
PubMed Identifier
26559246
Citation
Zhang MF, Wen YS, Liu WY, Peng LF, Wu XD, Liu QW. Effectiveness of Mindfulness-based Therapy for Reducing Anxiety and Depression in Patients With Cancer: A Meta-analysis. Medicine (Baltimore). 2015 Nov;94(45):e0897-0. doi: 10.1097/MD.0000000000000897.
Results Reference
result
PubMed Identifier
6880820
Citation
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Results Reference
result

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Art Therapy Effectiveness in the Level of Anxiety and Depression of Cancer Patients

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