Carcinoma
Conditions
Keywords
Basal Cell carcinoma, Squamous Cell carcinoma, Rhinectomy, Reconstructive Surgical Procedures, Prosthesis Implantation, FACE-Q, Quality of Life
Brief 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.
Interventions
OTHERoperated patients
Response 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)
OTHERControl
Response to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales : * Appearence : Face overall, nose, nostrils, skin impact psychological, impact social, * SF36
Sponsors
Hôpital NOVO
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychometric validation of the French version of Nasal Reconstruction FACE-Q | 7 days | Test the acceptability, reliability, construct validity, and sensitivity to change of the questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the post operative functional satisfaction | 7 days | 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. |
Countries
France
Contacts
STUDY_DIRECTORKhaled AL TABAA, Doctor
Hôpital NOVO
Outcome results
None listed