Cystic FibrosisMUCO-ART-PLUSNCT02932657
Perceived Impact of Art Therapy in Patients With Cystic Fibrosis and in Professional Interdisciplinary Teams Taking Care of Them.
An observational study of Cystic Fibrosis, run by Nantes University Hospital at 2 sites in France.
Trial summary
Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care teams perceive the boundaries of a support mainly focused on drug treatments. The patient had no other choice but to learn to live with their disease, the goal is to make every effort so that tames the disease while maintaining… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Non interventional study
- How many people
- 23 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Jun 2017to 28 Jan 2018
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Will be included in this research project: * Adolescents aged 13 to 18, followed by the cystic fibrosis Children center of Nantes that have benefited from art therapy session * Non transplanted adult patients followed cystic fibrosis center of Foch and having already benefited from art therapy session * The transplanted adult patients followed the transplantation center Foch and having already benefited from art therapy session
Who may be able to join
- Cystic fibrosis aged adolescents 13 to 18 years, as part of their monitoring at cystic fibrosis center of Nantes
- Adults over 18 years nontransplanted in their follow at cystic fibrosis center/transplantation center of Foch
- More than 18 adult transplant as part of their monitoring at cystic fibrosis center/transplantation center Foch
- Professional interdisciplinary teams taking care of the cystic fibrosis children center of Nantes, cystic fibrosis center/transplantation center of Foch
- Agreeing to participate in research
- Non Inclusion Criteria:
- Patient refusal of adolescent parents to participate in the study
- Professional refusal of teams to participate in the study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Nantes University Hospital
Nantes, 44093
Foch Hospital
Suresnes, 92151
About this study
Official title: Perceived Impact of Art Therapy in Patients With Cystic Fibrosis (Adolescents, Adults and Transplanted Not Transplanted) and in Professional Interdisciplinary Teams Taking Care of Them.
Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care teams perceive the boundaries of a support mainly focused on drug treatments. The patient had no other choice but to learn to live with their disease, the goal is to make every effort so that tames the disease while maintaining high self-esteem that gives meaning to his life, allowing, among other things, a good grip of treatment.
Through this research we hope to encourage the integration of art therapy in the course of care of cystic fibrosis patients, from children to adults before and after transplantation, in connection with the patient education and counseling
- Conditions
- Cystic Fibrosis
- Being tested
- Non interventional study
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
First individual interviews will be set up with teenagers of Nantes University Hospital . Then, focus group will be conduct with patients and professionals in Nantes and Foch University Hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient responses to the effects of art therapy and music therapy
The depth interviews with patients will achieve a thematic and structural analysis of the speech. This will capture the effects of art therapy and music therapy on patients, their point of view.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start29 Jun 2017
- Primary completion28 Jan 2018
- Study completion28 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie David, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932657
- Sponsor's protocol ID
- RC16_0285
- Acronym
- MUCO-ART-PLUS
- Status last verified
- Jan 2019
- First submitted
- 12 Oct 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Impact of Art Therapy in Patients With Cystic Fibrosis (Adolescents, Adults and Transplanted Not Transplanted) and in Professional Interdisciplinary Teams Taking Care of Them.
- ClinicalTrials.gov ID
- NCT02932657
- Acronym / sponsor ID
- MUCO-ART-PLUS / RC16_0285
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 28 Jan 2018 (actual)
- Study completion
- 28 Jan 2018 (actual)
- First posted
- 13 Oct 2016 (estimated)
- 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.
Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care teams perceive the boundaries of a support mainly focused on drug treatments. The patient had no other choice but to learn to live with their disease, the goal is to make every effort so that tames the disease while maintaining high self-esteem that gives meaning to his life, allowing, among other things, a good grip of treatment.
Through this research we hope to encourage the integration of art therapy in the course of care of cystic fibrosis patients, from children to adults before and after transplantation, in connection with the patient education and counseling
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Will be included in this research project: * Adolescents aged 13 to 18, followed by the cystic fibrosis Children center of Nantes that have benefited from art therapy session * Non transplanted adult patients followed cystic fibrosis center of Foch and having already benefited from art therapy session * The transplanted adult patients followed the transplantation center Foch and having already benefited from art therapy session
Key inclusion criteria (8 listed)
- Cystic fibrosis aged adolescents 13 to 18 years, as part of their monitoring at cystic fibrosis center of Nantes
- Adults over 18 years nontransplanted in their follow at cystic fibrosis center/transplantation center of Foch
- More than 18 adult transplant as part of their monitoring at cystic fibrosis center/transplantation center Foch
- Professional interdisciplinary teams taking care of the cystic fibrosis children center of Nantes, cystic fibrosis center/transplantation center of Foch
- Agreeing to participate in research
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Non interventional studyFirst individual interviews will be set up with teenagers of Nantes University Hospital . Then, focus group will be conduct with patients and professionals in Nantes and Foch University Hospital. | Other | – |
Primary outcome
Patient responses to the effects of art therapy and music therapy
Time frame: 1 day
The depth interviews with patients will achieve a thematic and structural analysis of the speech. This will capture the effects of art therapy and music therapy on patients, their point of view.
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 30 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Valérie David, Dr principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Nantes University Hospital at 2 sites 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 8 inclusion and 0 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Patient responses to the effects of art therapy and music therapy (time frame: 1 day). 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 30 Jan 2019.