Quality of Life in Patients With Difficult-to-Treat Basal Cell Carcinoma: An Evaluation of Impact and Surgical Outcomes. (FACE-QOL)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Basal Cell Carcinoma

Treatments: Other: Patient-reported outcome measures (PROMs)

Study type: Observational

Funder types: Other

Identifiers

NCT06448936

6722

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.