NCT02932657

Brief 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 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

October 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

June 29, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

October 12, 2016

Last Update Submit

January 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Interventions

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.

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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
  • Patient refusal of adolescent parents to participate in the study
  • Professional refusal of teams to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nantes University Hospital

Nantes, 44093, France

Location

Foch Hospital

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Valérie David, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 13, 2016

Study Start

June 29, 2017

Primary Completion

January 28, 2018

Study Completion

January 28, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations