NCT04936139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

2.7 years

First QC Date

June 14, 2021

Last Update Submit

February 2, 2024

Conditions

Keywords

Art TherapyDepressionAnxietyQuality of LifeCoping Skills

Outcome Measures

Primary Outcomes (2)

  • 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.

    3 months

  • 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.

    6 months

Secondary Outcomes (4)

  • World Health Organization Quality of Life (WHOQOL-BREF scale)

    3 months

  • World Health Organization Quality of Life (WHOQOL-BREF scale)

    6 months

  • Mini-Mental Adjustment to Cancer Scale (MINI-MAC)

    3 months

  • Mini-Mental Adjustment to Cancer Scale (MINI-MAC)

    6 months

Study Arms (2)

Art Therapy

EXPERIMENTAL

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

Behavioral: Art Therapy

Control group

NO INTERVENTION

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.

Interventions

Art TherapyBEHAVIORAL

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).

Art Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

Location

Related Publications (11)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

NeoplasmsDepressionAnxiety Disorders

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Pau Gomes, MsC

    Fundació Nou Cims

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator (Bachelor's in Nursing, MSc)

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 23, 2021

Study Start

February 21, 2021

Primary Completion

November 3, 2023

Study Completion

November 3, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations