NCT04133246

Brief Summary

The purpose of this study is to explore and collect the perceptions, expectations and needs of CF patients about parenting. This will be done in the context of several small groups of patients led by a psychologist who will ensure that all the participants express themselves; he will encourage them to develop their points of view, their divergences and their common points about what constitutes to be a parent. The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

September 4, 2019

Last Update Submit

November 17, 2025

Conditions

Cystic Fibrosis

Keywords

cystic fibrosisparenthoodPsycho-socialQualitative study

Outcome Measures

Primary Outcomes (1)

  • Identification of themes about parenthood in CF from groups

    by thematic analysis. 8 to 10 focus groups composed of 5 to 10 persons are to be conducted until saturation of themes.

    2 years

Secondary Outcomes (2)

  • Identification of themes about parenthood in CF from individual interviews

    2 years

  • Occurrence of themes

    2 years

Study Arms (2)

Group arm

OTHER

Includes subjects enrolled in focus groups

Behavioral: Focus group

Interview arm

OTHER

Includes subjects with individual interviews

Behavioral: Individual interview

Interventions

Focus groupBEHAVIORAL

Groups of 6 to 10 patients and spouses led by the psychologist about their parenthood lasting 2 hours

Group arm
Individual interviewBEHAVIORAL

Interview led by the psychologist about the patient's parenthood

Interview arm

Eligibility Criteria

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

You may qualify if:

  • For patients
  • Have cystic fibrosis
  • Be a parent and raise or have raised at least one child
  • Being followed in one of the two adult CF centers participating in the study
  • For CF patients' spouses
  • \- Live with the CF patient participating in the study
  • For both CF patients and spouses
  • Being an adult (at least 18 y.o.)
  • Have a good level of French and good speaking skills

You may not qualify if:

  • For both CF patients and spouses
  • Psychiatric pathology (borderline state, bipolarity and other psychotic disorders)
  • Serious somatic disease not related to cystic fibrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cochin Hospital

Paris, Île-de-France Region, 75012, France

Location

Foch Hospital

Suresnes, Île-de-France Region, 92150, France

Location

Related Publications (1)

  • Jacob A, Hubert D, Brain C, Grenet D, Flahault C. Exploring the lived experiences of parents living with cystic fibrosis: A qualitative study. J Health Psychol. 2025 Aug;30(9):2183-2200. doi: 10.1177/13591053241307874. Epub 2025 Jan 7.

    PMID: 39764735RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Cécile FLAHAULT, Ph.D

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

  • Dominique HUBERT, MD

    Assistance Publique - Hôpitaux de Paris

    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

September 4, 2019

First Posted

October 21, 2019

Study Start

September 25, 2019

Primary Completion

December 21, 2020

Study Completion

December 21, 2020

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)