French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Rehabilitation Following Nasal Skin Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 346
- 试验地点
- 9
- 主要终点
- Psychometric validation of the French version of Nasal Reconstruction FACE-Q
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Operated patients
Patients with skin cancer in the nasal region who have undergone surgical reconstruction using a flap or rehabilitation using a prosthesis.
干预措施: operated patients (Other)
Control
Patients with no history of surgery or facial trauma
干预措施: Control (Other)
结局指标
主要结局
Psychometric validation of the French version of Nasal Reconstruction FACE-Q
时间窗: 7 days
Test the acceptability, reliability, construct validity, and sensitivity to change of the questionnaire.
次要结局
- Assessment of the post operative functional satisfaction(7 days)