About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Patient who has undergone excision of a cutaneous, mucocutaneous, or vestibular nasal cancer with surgical reconstruction using a flap or prosthetic rehabilitation, performed more than 4 months ago, with stable results, and less than 3 years ago
Patient informed of the study and not opposed to participation
Disqualifiers
Patient under anticoagulant or antiplatelet therapy Non-French-speaking patient
Patient under legal protection (e.g., guardianship, legal safeguard) or with limited legal capacity
Patient unlikely to cooperate with the study and/or poor anticipated compliance as judged by the investigator (including psychiatric disorders other than depressive disorder or cognitive impairment)
Pregnant or breastfeeding woman
Trial population
Patients / Controls
Trial design
Case-control
Prospective
Treatments tested in this trial
operated patients
Other interventionResponse 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)
Control
Other interventionResponse to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales : * Appearence : Face overall, nose, nostrils, skin impact psychological, impact social, * SF36
Treatment groups
Trial outcomes
Primary outcomes
Psychometric validation of the French version of Nasal Reconstruction FACE-Q
Test the acceptability, reliability, construct validity, and sensitivity to change of the questionnaire.
Secondary outcomes
Assessment of the post operative functional satisfaction
Evaluation of postoperative functional satisfaction using the Nasal Obstruction Symptom Evaluation (NOSE) questionnaire, which measures the severity of nasal breathing obstruction. Correlations will then be calculated between the NOSE and each of the FACE-Q.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.