Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus

NCT06934759 | Enrolling By Invitation

• 1 other identifier: 2024PI238
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to describe the experiences of parents at the birth of a child with a large or giant congenital melanocytic nevus through semi-structured interviews, and to identify potential intervention strategies to improve their care and support.

Conditions

Congenital Melanocytic Nevi; Congenital Melanocytic Nevus; Parent; Psychology, Social

Keywords

parents; congenital melanocytic nevus; congenital melanocytic nevi; psychology; lived experience

Outcome Measures

Primary Outcomes (1)

• Results of the Semi-Structured Interviews with Parents

  Analysis of the interview transcripts = verbatim analysis Individual semi-structured interviews will be conducted via videoconference, with an estimated duration of 30 minutes to 1 hour. An interview guide has been developed to define the key dimensions to be explored. Each interview will be audio-recorded using a voice recorder and then fully transcribed. The interviews will undergo a thematic content analysis to identify meaningful patterns ("nodes of meaning") within participants' narratives, using an inductive approach. A double coding will be performed by two investigators on five interviews to strengthen the thematic framework. The remaining interviews will be coded by a single investigator

  Socio-demographic data and interview transcripts will be collected during the semi-structured interviews (lasting between 30 minutes and 1 hour), thus at a single time point (Day 1). No follow-up is required.

Study Arms (1)

Children with congenital melanocytic nevus

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

There is no intervention

Children with congenital melanocytic nevus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will include parents of children with a large or giant congenital melanocytic nevus who are being followed at the university hospitals (CHRU) of Nancy, Marseille, Nantes, Dijon, Necker, Nice, Brest, Annecy, Grenoble and Saint Pierre.

You may qualify if:

• Aged 18 years or older
• Willing to participate in a semi-structured interview
• Has received full information about the research and has not objected to participating or to the use of their data
• Able to understand and speak French
• Parent of a child under 18 years of age

You may not qualify if:

• Under 18 years of age
• Not willing to participate
• Currently under legal protection (e.g., guardianship or curatorship)
• Cognitive and/or psychological impairments preventing participation in a semi-structured interview
• Poor understanding and/or expression of the French language
• Parent of a child over 18 years of age

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Assistance Publique Hopitaux De Marseille: collaborator
• Hôpital Necker-Enfants Malades: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• University Hospital, Brest: collaborator
• Annecy Hospital, France: collaborator
• Centre Hospitalier Universitaire Dijon: collaborator
• Nantes University Hospital: collaborator
• University Hospital, Grenoble: collaborator
• Centre Hospitalier Universitaire de la Réunion: collaborator

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Nancy, France, 54035, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Principal Investigator

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (1)