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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Surgery in difficult-to-treat basal cell carcinoma
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Surgery in difficult-to-treat basal cell carcinoma
时间窗: 1 year
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.
次要结局
- Predictive variables(1 year)
- Validation of the NAFEQ score.(1 year)