Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04133246 |
| Other study ID # |
2018-A03241-54 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2019 |
| Est. completion date |
December 21, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
