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

March 26, 2026 updated by: Hôpital NOVO

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

346

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Not yet recruiting
        • CHU Caen
        • Contact:
      • Nice, France, 06000
      • Paris, France, 75005
        • Not yet recruiting
        • Institut Curie
        • Contact:
      • Paris, France, 75010
        • Not yet recruiting
        • Hôpital Lariboisière (AP-HP)
        • Contact:
      • Paris, France, 75018
        • Not yet recruiting
        • Hôpital Bichat (APHP)
        • Contact:
      • Pontoise, France, 95300
        • Recruiting
        • Hôpital NOVO
        • Contact:
      • Toulon, France, 83000
      • Toulouse, France, 31400
      • Villejuif, France, 94800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients / Controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Patients with no history of surgery or facial trauma
Other: Control

Response to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales :

  • Appearence : Face overall, nose, nostrils, skin impact psychological, impact social,
  • SF36
Operated patients
Patients with skin cancer in the nasal region who have undergone surgical reconstruction using a flap or rehabilitation using a prosthesis.
Other: operated 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychometric validation of the French version of Nasal Reconstruction FACE-Q
Time Frame: 7 days
Test the acceptability, reliability, construct validity, and sensitivity to change of the questionnaire.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the post operative functional satisfaction
Time Frame: 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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital NOVO

Investigators

  • Study Director: Khaled AL TABAA, Doctor, Hôpital NOVO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A02195-44
  • CHRD 1424 (Other Identifier: HOPITAL NOVO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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