CompletedNot Applicable

Qualitative and Quantitative Study Which Aims to Determine the Specifics of the Announcement for the Diagnosis of Patients With Craniosynostosis and Their Parents to Better Support Them in Their Care

France574 participantsStarted 2014-10

Plain-language summary

The purposes of this study are: * to better understand the experience of the announcement for the diagnostic of craniosynostosis to patients and their families to improve the understanding of it and it modes of appropriation * to compare the announcement process concerning "simple" and "complex" forms. * to identify the intra-family issues at the announcement of a genetic mutation. * to reconstruct the care course of patients by analyzing the time of the announcement and the post-operative period.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria : Group 1 : Parents of operated children with a clinical diagnosis of craniosynostosis Group 2 : * Parents of newly diagnosed children for a craniosynostosis who will be operated * Children aged 15 who were operated for a craniosynostosis at least 10 years ago Group 3 : * Parents of newly diagnosed children for a craniosynostosis who will be operated * Children aged 15 who were operated for a craniosynostosis at least 10 years ago Exclusion Criteria: * nothing to declare

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

measure by questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)

Timeframe: 5 months

Trial details

NCT IDNCT02287805

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Craniosynostosis trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.