Evaluating quality of life in patients with difficult-to-treat basal cell carcinoma after surgery
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.
This study looks at how surgery affects the daily lives and well-being of people with hard-to-treat basal cell carcinoma on their face.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Roma) |
| Trial ID | NCT06448936 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how surgical treatment affects the quality of life in patients with stage IIA and IIIB difficult-to-treat basal cell carcinoma located on the face. By utilizing patient-reported outcome measures, the study will gather data on the impact of surgery on daily living and overall well-being. Participants will complete questionnaires to provide insights into their experiences and the factors influencing their quality of life post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with stage IIA or IIIB difficult-to-treat basal cell carcinoma on the face who can communicate in Italian.
Not a fit: Patients with inoperable or metastatic basal cell carcinoma or those with psychiatric disorders that hinder compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how surgical interventions can improve the quality of life for patients with challenging facial basal cell carcinoma.
How similar studies have performed: While this approach is observational, similar studies have shown that surgical treatment can significantly impact quality of life in cancer patients, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea Paradisi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Andrea Paradisi
- Email: andrea.paradisi@policlinicogemelli.it
- Phone: +393341904483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.