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| ID | Type | Description | Link |
|---|---|---|---|
| CHRD 1424 | Other Identifier | HOPITAL NOVO |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operated patients | Patients with skin cancer in the nasal region who have undergone surgical reconstruction using a flap or rehabilitation using a prosthesis. |
| |
| Control | Patients with no history of surgery or facial trauma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| operated patients | Other | Response to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales :
|
| Measure | Description | Time Frame |
|---|---|---|
| Psychometric validation of the French version of Nasal Reconstruction FACE-Q | Test the acceptability, reliability, construct validity, and sensitivity to change of the questionnaire. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
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PATIENTS
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CONTROL
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Patients / Controls
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| Name | Affiliation | Role |
|---|---|---|
| Khaled AL TABAA, Doctor | Hôpital NOVO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen | Not yet recruiting | Caen | 14000 | France |
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| Control | Other | Response to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales :
|
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| Centre Antoine Lacassagne | Recruiting | Nice | 06000 | France |
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| Institut Curie | Not yet recruiting | Paris | 75005 | France |
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| Hôpital Lariboisière (AP-HP) | Not yet recruiting | Paris | 75010 | France |
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| Hôpital Bichat (APHP) | Not yet recruiting | Paris | 75018 | France |
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| Hopital Novo | Recruiting | Pontoise | 95300 | France |
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| HNIA Toulon | Recruiting | Toulon | 83000 | France |
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| CHU Toulouse | Not yet recruiting | Toulouse | 31400 | France |
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| Institut Gustave Roussy | Recruiting | Villejuif | 94800 | France |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |
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