NCT03420690

Brief Summary

Negative symptoms in cancer in palliative care, such as pain, can lead to a withdrawal that can lead to a form of social exclusion. Maintaining pre-illness relationships is often difficult for the patient, especially since he is often not available to relationships. Art therapy defined as the exploitation of artistic potential in a therapeutic and humanitarian aim can contribute to the reduction of symptoms, to adaptation and to well-being. A recent review shows that positive affective states and meaningful social connections are important factors contributing to more effective adaptation to pain. Study hypothesis is that art therapy could play on these two factors. The objective of the qualitative study is to measure, using a questionnaire, the indirect impact of art therapy sessions on parents, during support and after death, from a relational and emotional point of view.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

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

January 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

June 24, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

January 29, 2018

Last Update Submit

June 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall satisfaction with art therapy

    The primary endpoint is the item of overall satisfaction with art therapy session in 3 groups (VAS scale between 0 and 3, between 3 and 7 and between 7 and 10)

    6 month

Study Arms (1)

Family of patient

Other: satisfaction questionnaire after art therapy session

Interventions

After the administration of art therapy sessions (\>1) and the death of patients (\> 1 month), the intervention consists in submitting to families of patients a satisfaction questionnaire intended to evaluate the impact of art therapy session and in particular about their relationships.

Family of patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Close to a patient who died more than 1 month old and who benefited from more than one art therapy session in the palliative care unit.

You may qualify if:

  • Any major person who has accompanied a patient to the palliative care unit of the Lyon-Sud hospital
  • Man or woman ;
  • years old or older;
  • Death of the accompanied patient\> 1 month;
  • Number of art therapy session of the accompanied patient \> 1;
  • Having agreed to participate in the study;
  • Not subject to a legal protection measure.

You may not qualify if:

  • Nobody without the physical or mental abilities to respond to the questionnaire ;
  • No one reading or speaking French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Study Officials

  • Marilène FILBET, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 5, 2018

Study Start

June 24, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations