Parenting Concerns in Patients With Cystic Fibrosis (MucoPar) (MucoPar)

Expectations and Needs of Patients With Cystic Fibrosis Becoming Parents - Exploratory Study

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

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Focus group; Behavioral: Individual interview

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75012
      • Cochin Hospital
    • Suresnes, Ile De France, France, 92150
      • Foch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group arm; Includes subjects enrolled in focus groups	Behavioral: Focus group; Groups of 6 to 10 patients and spouses led by the psychologist about their parenthood lasting 2 hours
Other: Interview arm; Includes subjects with individual interviews	Behavioral: Individual interview; Interview led by the psychologist about the patient's parenthood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of themes about parenthood in CF from individual interviews	by the IPA method. 20 individual interviews are to be conducted until saturation of themes	2 years
Occurrence of themes	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	2 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Cécile FLAHAULT, Ph.D, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: cystic fibrosis; parenthood; Qualitative study; Psycho-social
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 2018-A03241-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No