Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Financial Toxicity
研究概览
简要总结
Objectives:
- Assess the extent of financial burden of patients undergoing radiotherapy
- Identify clinical and socio-economical factors correlated with the occurrence and extent of financial toxicity
- Design a structured social consultation to reduce financial burden induced by radiotherapy
Inclusion criteria:
- age ≥ 18 years of age
- indication for radiation treatment of a malignant disease
- Karnofsky Performance score (KPS) ≥ 70%
- Life expectancy ≥ 3 months
Exclusion criteria:
- Inability to provide informed consent
- Inability to attend study visits and fulfill data collection requirements
- Simultaneous participation in other studies which could interfere with this study Primary outcome: Financial burden as expressed by the COST score, measured at baseline and 3 months after completion of radiotherapy
Secondary outcomes:
- Socio-Economic factors at baseline
- Health-related quality of life (EORTC QLQ-C30) at baseline and 3 months
- Depression (PHQ-9) at baseline and 3 months
- Coping mechanisms to address financial burden
Primary Endpoint: Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months.
Secondary Endpoints:
- Changes in the COST-Score over time
- Changes in PHQ-9 over time
- Changes in EORTC QLQ-C30 over time
This is an exploratory pilot study. To assess the compliance and effectiveness of the used methods all patients willing to participate in the given time period will be enrolled.
To be assessed for eligibility: n = 300 To be allocated/randomised (if applicable) to trial: n = 150 To be analysed: n = 120
详细描述
The study is designed as a multicenter longitudinal exploratory study of 150 patients. Further details regarding study timetable, inclusion and exclusion criteria and intervention schedule are explained in the destined subsections of this form.
Data is recorded digitally using an electronic case report forms (eCRF). All data is stored pseudonymized in a REDCap® database.
Before enrolment in register, patients will be informed that participation is voluntary and that they may withdraw at any time without having to give reasons and without penalty or loss of benefits to which the subject is otherwise entitled.
In addition, the subject will be given a "Subject Information Sheet", which contains all the important information in writing.
Findings obtained in the course of the cohort study will be stored on electronic media and treated in strict confidence. For the protection of these data, organisational measures have been taken to prevent disclosure to unauthorised third parties.
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
- •cancer diagnosis with indication for radiation
- •Karnofsky index minimum 70%
- •able to consent
- •minimum 18 years old
排除标准
- •Inability to provide informed consent
- •Inability to attend study visits and fulfill data collection requirements
- •Simultaneous participation in other studies which could interfere with this study
结局指标
主要结局
Financial Toxicity
时间窗: 4 months
Measure instrument: Comprehensive Score for financial Toxicity COST score. COST score ranges from 0 (severe) to 44 points (no effect). Primary endpoint: Changes in COST-Score over time. Assessment before radiation therapy, after and 3 months after.
次要结局
- Factors that may influence the occurrence or extent of financial burden(4 months)
研究者
Prof. Dr. Rami El Shafie
Chief of UMG Radiotherapy
University Medical Center Goettingen