Basal Cell Carcinoma
Conditions
Brief summary
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.
Interventions
OTHERPatient-reported outcome measures (PROMs)
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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical or histological diagnosis of difficult-to-treat basal cell carcinoma (DTT-BCC) classified as stage IIA or IIIB according to the EADO classification. * Tumor location: face. * Intervention: surgical treatment of facial stage IIA and IIIB difficult-to-treat basal cell carcinoma. * Sufficient knowledge of spoken and written Italian by the patient.
Exclusion criteria
* Known psychiatric or substance abuse disorders that may interfere with cooperation and compliance with trial requirements. * Inoperable or metastatic difficult-to-treat basal cell carcinoma. * Contraindications to surgery related to the patient's condition. * Previous radiation therapy involving the field of the target lesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgery in difficult-to-treat basal cell carcinoma | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictive variables | 1 year | 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.). |
| Validation of the NAFEQ score. | 1 year | 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. |
Countries
Italy
Contacts
Primary ContactAndrea Paradisi
Backup ContactArianna Meoni
Outcome results
None listed