HealthyATRELNCT03420690
Study of the Impact of Art Therapy in Palliative Care on the Relationship Between Patients and Their Families
An observational study of Healthy, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- satisfaction questionnaire after art therapy session
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Any major person who has accompanied a patient to the palliative care unit of the Lyon-Sud hospital
- Man or woman ;
- 18 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.
Who cannot join
- Nobody without the physical or mental abilities to respond to the questionnaire ;
- No one reading or speaking French.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- satisfaction questionnaire after art therapy session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
satisfaction questionnaire after art therapy sessionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Family of patient | Not described Receives: Other: satisfaction questionnaire after art therapy session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start24 Jun 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilène FILBET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420690
- Sponsor's protocol ID
- 69HCL17_0626
- Acronym
- ATREL
- Status last verified
- Jun 2021
- First submitted
- 29 Jan 2018
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Art Therapy in Palliative Care on the Relationship Between Patients and Their Families
- ClinicalTrials.gov ID
- NCT03420690
- Acronym / sponsor ID
- ATREL / 69HCL17_0626
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Jun 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family of patient | – | Other: satisfaction questionnaire after art therapy session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Any major person who has accompanied a patient to the palliative care unit of the Lyon-Sud hospital
- Man or woman ;
- 18 years old or older;
- Death of the accompanied patient> 1 month;
- Number of art therapy session of the accompanied patient > 1;
Key exclusion criteria (2 listed)
- Nobody without the physical or mental abilities to respond to the questionnaire ;
- No one reading or speaking French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| satisfaction questionnaire after art therapy sessionAfter 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. | Other | Family of patient |
Primary outcome
Overall satisfaction with art therapy
Time frame: 6 month
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilène FILBET, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall satisfaction with art therapy (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.