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

NCT06448936 | Recruiting

• 1 other identifier: 6722
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Predictive variables

  1 year

• Validation of the NAFEQ score.

  1 year

Interventions

Patient-reported outcome measures (PROMs) OTHER

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.

Also known as: GHQ-12 Questionnaire, Skindex-17 Questionnaire, PRISM Questionnaire, NAFEQ Questionnaire, Skin Cancer Index Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Andrea Paradisi

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Paradisi

CONTACT

+393341904483; andrea.paradisi@policlinicogemelli.it

Arianna Meoni

CONTACT

+393202347290; a.meoni98@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 7, 2024
• Study Start: June 3, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 3, 2025

Record last verified: 2024-05

Locations

IT (1)