Quality of Life in Patients With Difficult-to-Treat Basal Cell Carcinoma: An Evaluation of Impact and Surgical Outcomes.
Assessment of Quality of Life in Patients Undergoing Surgery for Difficult-to-treat Basal Cell Carcinoma of the Face in Stage IIA or IIIB According to the European Association of Dermato-Oncology Classification.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
750 participants
Jun 3, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06448936