FACE-QoL is an observational, prospective, multicenter study aimed at evaluating the impact of surgical treatment on quality of life in patients with stage IIA and IIIB difficult-to-treat basal cell carcinoma of the face, according to the European Academy of Dermato-Oncology classification, using patient-reported outcomes. The main questions the study seeks to answer are: Can surgery, as the gold standard treatment, lead to an improvement in the quality of life of patients with difficult-to-treat basal cell carcinoma in functionally and cosmetically challenging sites of the face (i.e., stage IIA and IIIB)? Which clinical and individual variables have the greatest impact on patients' quality of life? Participants will complete questionnaires assessing their quality of life and the impact of the disease on their daily lives.
Study Type
OBSERVATIONAL
Enrollment
750
Administration of questionnaires investigating the impact of facial difficult-to-treat basal cell carcinoma treated by surgery on patient's quality of life over the course of one year. The questionnaires will be submitted at baseline (i.e., before surgery) and at 3-months follow up.
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
RECRUITINGSurgery in difficult-to-treat basal cell carcinoma
The primary outcome is to assess the change in quality of life in patients with difficult-to-treat basal cell carcinoma (DTT-BCC) of the face (stage IIA and IIIB according to the European Association of Dermato-Oncology classification) before and after surgery, as measured by various questionnaires.
Time frame: 1 year
Predictive variables
A secondary endpoint is to identify which clinical and individual variables have the greatest impact on patients' quality of life (e.g., age, gender, tumor site or size, primary vs. recurrent, type of reconstruction, etc.).
Time frame: 1 year
Validation of the NAFEQ score.
A secondary endpoint is to validate the Italian version of the NAFEQ score (Nasal Appearance and Function Evaluation Questionnaire) to assess the impact of surgery on quality of life in patients with DTT-BCCs of the nose (including various nasal subunits, such as the dorsum, ala, side wall, tip, etc.). The questionnaire consists of 14 questions directed to patients, with a total score ranging from 18 to 66, where a score of 66 indicates post-surgical clinical and aesthetic improvement.
Time frame: 1 year
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