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

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.

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 Overview

• Status: Recruiting
• Conditions: Basal Cell Carcinoma
• Intervention / Treatment: Other: Patient-reported outcome measures (PROMs)

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Andrea Paradisi; Phone Number: +393341904483; Email: andrea.paradisi@policlinicogemelli.it
• Study Contact Backup: Name: Arianna Meoni; Phone Number: +393202347290; Email: a.meoni98@gmail.com

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Andrea Paradisi; Phone Number: +393341904483; Email: andrea.paradisi@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Sequential recruitment of 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 (EADO) classification.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery 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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.).	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.	1 year

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Andrea Paradisi, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: 6722

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No