Parenting Concerns in Patients With Cystic Fibrosis (MucoPar)

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Focus group; Behavioral: Individual interview

• Registration Number: NCT04133246
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Detailed Description

Life expectancy has improved significantly in cystic fibrosis in recent years. From paediatric disease, it has become a disease of the adult, with the emergence of new issues, such as becoming a parent. Parent patients still face the risk of complications and death while their child is still young. However, there is very little data in the literature on parenting in cystic fibrosis.

Therefore, the purpose of this study is to explore and collect the perceptions, expectations and needs of CF patients and their spouses about parenting.

All patients with children, followed in 2 large adult CF centers, and their spouses will be invited to participate in a 6 to 10-person discussion group (focus group) led by a psychologist. He will ensure that all the participants express themselves and are encouraged to develop their points of view, their divergences and their common points about what constitutes to be a parent. The discussions will be recorded and transcribed.

Patients who cannot participate in groups (e.g. patients colonized with Burkholderia cepacia complex) but wish to be included in the study will benefit from an individual interview with the psychologist, also registered and transcribed. A thematic analysis will be carried out from the transcriptions of group contents. For individual interviews, phenomenological interpretative analysis (IPA) will be used. A synthesis of the two analyses will then be done.

The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations.

Study Timeline

• Study First Submitted: 2019-09-04
• Study Start: 2019-09-25
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-21
• Primary Completion: 2020-12-21
• Study Completion: 2020-12-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group arm	Focus group	Includes subjects enrolled in focus groups
Interview arm	Individual interview	Includes subjects with individual interviews

Primary Outcome Measures

Name	Time	Method
Identification of themes about parenthood in CF from groups	2 years	by thematic analysis. 8 to 10 focus groups composed of 5 to 10 persons are to be conducted until saturation of themes.

Secondary Outcome Measures

Name	Time	Method
Identification of themes about parenthood in CF from individual interviews	2 years	by the IPA method. 20 individual interviews are to be conducted until saturation of themes
Occurrence of themes	2 years	number of appearances of each theme, revealed by the 2 analyses, in the group arm on one hand, and in the interview arm on the other hand. The occurrence will provide information on the importance of each theme

Trial Locations

Locations (2)

Cochin Hospital; 🇫🇷 Paris, Ile De France, France

Foch Hospital; 🇫🇷 Suresnes, Ile De France, France