Validate a French Nasal Reconstruction FACE-Q quality-of-life questionnaire
French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Rehabilitation Following Nasal Skin Cancer
This project tests a French version of the Nasal Reconstruction FACE-Q questionnaire with adults who had nasal reconstruction or prosthetic rehabilitation after nasal skin cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 346 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hôpital NOVO Academic / other |
| Locations | 9 sites (Caen and 8 other locations) |
| Trial ID | NCT07257094 on ClinicalTrials.gov |
What this trial studies
This non-interventional, multicenter project will translate and culturally adapt selected FACE-Q Aesthetics scales into French and then collect patient-reported responses to test reliability and validity. Adults who had nasal excision for skin cancer followed by reconstructive flap surgery or prosthetic rehabilitation between 4 months and 3 years prior will complete the questionnaires at participating centers. A control group of older adults without prior facial surgery will provide comparative normative data. The goal is to produce a standardized French-language instrument that reliably measures appearance, psychosocial well-being, social function, satisfaction with outcomes, and procedure-related adverse effects.
Who should consider this trial
Good fit: Adults (≥18 years), French-speaking, who had excision of nasal skin cancer followed by surgical reconstruction with a flap or prosthetic rehabilitation between 4 months and 3 years ago and who can give informed consent are ideal candidates.
Not a fit: Non-French-speaking patients, those with surgery less than 4 months or more than 3 years ago, patients under anticoagulant/antiplatelet therapy, those under legal protection or with limited capacity, pregnant or breastfeeding women, and patients unlikely to cooperate are not expected to benefit from participation.
Why it matters
Potential benefit: If successful, clinicians and researchers will have a reliable French tool to measure patient satisfaction and quality of life after nasal reconstruction, improving follow-up care and enabling standardized comparisons across studies.
How similar studies have performed: FACE-Q instruments have been successfully translated and validated in other languages and aesthetic/reconstructive settings, so this French nasal reconstruction adaptation follows an established and previously successful approach.
Eligibility criteria
Show full inclusion / exclusion criteria
PATIENTS Inclusion Criteria * 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 Exclusion Criteria * 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 CONTROL Inclusion Criteria * Age ≥ 65 years * Subject informed and not opposed to participating in the study * Subject who has never undergone facial trauma or surgery, and without major comorbidity, defined as follows: * No heart failure (moderate or severe heart failure, history of heart attack within the last 6 months); * No severe chronic respiratory disease (no stage III-IV COPD, no prolonged oxygen therapy); * No uncontrolled diabetes or associated severe complications; * No active immunosuppressive diseases or high-dose immunosuppressive treatment; * No unstable or severe facial dermatological conditions; * No comorbidities seriously affecting quality of life or respiratory function (at the investigator's discretion). Exclusion Criteria * Non-English speaking subject * Subject under guardianship or legal protection, legally incompetent or with limited legal capacity * Subject unlikely to cooperate in the study and/or anticipated low cooperation by the investigator (particularly those with psychiatric disorders other than depression or cognitive disorders) * Pregnant or breastfeeding women
Where this trial is running
Caen and 8 other locations
- CHU Caen — Caen, France (Not_yet_recruiting)
- Centre Antoine Lacassagne — Nice, France (Recruiting)
- Institut Curie — Paris, France (Not_yet_recruiting)
- Hôpital Lariboisière (AP-HP) — Paris, France (Not_yet_recruiting)
- Hôpital Bichat (APHP) — Paris, France (Not_yet_recruiting)
- Hopital Novo — Pontoise, France (Recruiting)
- HNIA Toulon — Toulon, France (Recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
- Institut Gustave Roussy — Villejuif, France (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.