Financial Toxicity and Patient-Reported Outcomes in Italian Patients Affected by Gastroenteropancreatic Neuroendocrine Neoplasms (GEP-NEN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Financial toxicity
研究概览
简要总结
The aim of this study is to evaluate the financial toxicity reported by Italian patients affected by GEP-NEN during the first year of treatment after diagnosis and its correlations with patient-reported outcomes (PROs) and quality of life (QoL).
详细描述
Gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN) are rare tumours whose incidence has increased during the years. However, referral centers specialized in diagnosis and treatment of these diseases are few. So, patients may be forced to travel long distances in order to reach a disease specialized center (ENETS certification) to plan the correct management and receive the better treatment. On the other hand, patients could research different clinical consulting by several medical specialists without clear indication. Moreover, today also advanced disease allows the patients a good prognosis with long survival. The resulting emotional and psychological burden may contribute to the worse quality of life. Therefore, patients with GEP-NEN have a deal with the financial consequences related to the diagnosis and treatment of their disease including out of pocket costs, loss of income and caregiver burden. Financial toxicity, defined as subjective financial concerns of cancer and objective financial consequences, has been investigated in this study in Italian patients affected by GEP-NEN
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •≥18 years of age
- •New diagnosis of gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN)
- •Patients who are candidates for surgical and/or medical treatment [including somatostatin analogues (SAA), peptide recector radionuclide therapy (PRRT), target therapies (everolimus or sunitinib) and chemotherapy];
- •Signed informed consent
排除标准
- •Age < 18 years
- •Patients diagnosed with GEP-NEN who are candidates for a surveillance management.
- •Patients diagnosed with GEP-NEN who are candidates for best supportive care and/or have a life expectancy < 6 months.
结局指标
主要结局
Financial toxicity
时间窗: 12 months
Financial toxicity measured by Comprehensive Score for financial toxicity (COST) and out of pockets.
Quality of Life (QoL)
时间窗: 12 months
Evaluate the QoL of patients affected by GEP-NEN, as measured by the Questionnaires assessing the QoL of Cancer Patients (QLQ-C30)
次要结局
未报告次要终点
研究者
Massimo Falconi
Head od Pancreatic Surgery Unit
IRCCS San Raffaele