NCT02801045

Brief Summary

This study evaluates from the patient's perspective which elements of the own artistic creative process are the source of a beneficial change for him/her and how those elements influence in their end of life experience.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 20, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

3.7 years

First QC Date

May 30, 2016

Last Update Submit

March 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reflect Interview (RI) using audio recording.

    An art based interview is administered and involves the patients selecting 2 significant artworks from their art therapy productions. The patient is asked by the art therapist for a narrative of how one artwork relates to the other in the context of his/her lived experience. The art therapy dialogue from the RI is transcribed and subjected to thematic analysis.

    After the making of a minimum of 5 art pieces, an average of 2 weeks

Secondary Outcomes (1)

  • Art therapy process from the art therapist perspective.

    Every day of art therapy session, with an average of 2 sessions a week, over a period of 2 years.

Study Arms (1)

art therapy

EXPERIMENTAL

Individual 30-60 minutes art therapy sessions, twice a week, offering visual arts materials.

Behavioral: art therapy

Interventions

art therapyBEHAVIORAL

Patient's creativity is stimulated by visual arts materials and various art therapy techniques including punctual use of music, poetry and body expression. The intervention, based on the investigators previous experience, is founded on: * humanistic phenomenological focus * transpersonal therapeutic bound * transdisciplinarity in the artistic approach * integrative-relational specialized counseling of the grief, loss and trauma aspects.

art therapy

Eligibility Criteria

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

You may qualify if:

  • advanced-cancer adult inpatients of the Palliative Care Unit
  • informed consent

You may not qualify if:

  • altered cognitive function (Mini-Mental Test \< 24)
  • physical decline (palliative care team's criteria) that impedes the art therapy process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Antonio Pascual, MD

    Palliative Care Unit, Sant Pau Hospital, Barcelona, Spain.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 15, 2016

Study Start

October 20, 2016

Primary Completion

June 30, 2020

Study Completion

December 31, 2020

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations