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RecruitingNCT07257094

Nasal Reconstruction FACE-Q : French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Rehabilitation Following Nasal Skin Cancer

French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Rehabilitation Following Nasal Skin Cancer

Status
Recruiting
Phase
Study type
Observational
Enrollment
346 (estimated)
Sponsor
Hôpital NOVO · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study aims to validate a French version of the Nasal Reconstruction FACE-Q questionnaire for patients who have undergone nasal reconstruction or prosthetic rehabilitation after surgery for nasal skin cancer. The questionnaire evaluates appearance, quality of life, and possible side effects related to the reconstruction. The investigators hypothesize that the validated French version will provide a reliable and standardized tool to assess patient satisfaction and health-related quality of life in this context.

Detailed description

Nasal skin cancers often require surgical excision that can result in significant tissue loss. Treatment may involve complex surgical reconstruction or, in some cases, prosthetic rehabilitation. These procedures may have major aesthetic, functional, and psychological consequences. FACE-Q is an internationally recognized, patient-reported outcome instrument designed to assess satisfaction with appearance, health-related quality of life, and treatment-related adverse effects. However, FACE-Q was developed and validated in English and requires cultural and linguistic adaptation for reliable use in French-speaking populations. This non-interventional, multicenter study aims to translate and validate the relevant FACE-Q Aesthetics scales in French for patients who have undergone nasal reconstruction or prosthetic rehabilitation after skin cancer. The selected domains address facial and nasal appearance, psychosocial well-being, social function, satisfaction with outcomes, and procedure-related adverse effects. The expected outcome is to provide a standardized and validated French-language tool that reliably evaluates these patients' satisfaction and quality of life. Such a tool may be applied in clinical practice and future comparative research to improve patient care.

Conditions

Interventions

TypeNameDescription
OTHERoperated patientsResponse to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales : * Appearence : Face overall, nose, nostrils, skin * Health related quality of life (HRQOL) : Early life impact, psychological, social, outcome * Adverse effects : on the nose, on the forehead, eyebrows and scalp * Nasal Obstruction Symptom Evaluation (NOSE) * Short-Form-36 (SF 36)
OTHERControlResponse to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales : * Appearence : Face overall, nose, nostrils, skin impact psychological, impact social, * SF36

Timeline

Start date
2026-01-10
Primary completion
2027-07-30
Completion
2027-07-30
First posted
2025-12-02
Last updated
2026-03-31

Locations

9 sites across 1 country: France

Source: ClinicalTrials.gov record NCT07257094. Inclusion in this directory is not an endorsement.