Valutazione Della "Financial Toxicity" Nei Pazienti Sottoposti a Radioterapia: Uno Studio Multicentrico Italiano Promosso da yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Financial toxicity (PROFFIT financial score and "determinants")
研究概览
简要总结
Non- profit, multicenter, prospective, observational study. The study aims to assess financial toxicity (FT) in patients undergoing radiotherapy for oncological diseases, assessed with a validated questionnaire (Patient Reported Outcome for Fighting FInancial Toxicity-PROFFIT- questionnaire).
详细描述
PROFFIT questionnaire is an Italian instrument for evaluating FT in cancer patients in the Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT financial score) and 9 measuring possible determinants of FT. The primary objective of the study is to assess FT in patients undergoing radiotherapy for oncological diseases and compare FT in different patients group defined according to baseline characteristics (oncologic disease, type of radiotherapy and treatment, age and sex).
Primary comparison will be based on PROFFIT questionnaire fulfilled at baseline (before starting radiotherapy), at the end of RT treatment, at first follow-up visit (1-2 months after the end of RT).
Exploratory analyses will be conducted to verify whether changes in the FT score during treatment are correlated with QOL (EORTC QLQ-C30 questionnaire), toxicity (PRO-CTCAE), and overall survival.
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
- •Patients older than 18 years of age.
- •Histological diagnosis of malignancy for which the patient requires radiotherapy treatment.
排除标准
- •Patient refusal to complete the questionnaire.
结局指标
主要结局
Financial toxicity (PROFFIT financial score and "determinants")
时间窗: baseline (before starting RT), periprocedural (end of radiotherapy treatment, average of 1-2 months); 1-2 months after the end of RT(first follow-up visit) up to 12 months.
PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire. It will be calculated according to published rules (Riva S, et al. BMJ Open. 2019 Sep;9(9):e031485). The baseline score for determinants (items 8-16) and their change during treatment
次要结局
未报告次要终点
研究者
Valerio Nardone
Clinical Professor
University of Campania Luigi Vanvitelli