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

ConditionCarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital NOVO

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • operated patients

    Other intervention

    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)

  • Control

    Other intervention

    Response 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

346 Participants
are divided into 2 treatment groups
Group A: Operated patients1 intervention
Group B: Control1 intervention

Trial outcomes

Primary outcomes

1

Psychometric validation of the French version of Nasal Reconstruction FACE-Q

Test the acceptability, reliability, construct validity, and sensitivity to change of the questionnaire.

Time frame
7 days

Secondary outcomes

1

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.

Time frame
7 days

Other outcomes

Sponsors and contacts

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