Burden of financial toxicity in Breast Cancer patients treated with curative intend: a multi-national study from low-middle income countries (FIT Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Estimate of catastrophic health expenditure (CHE)
研究概览
简要总结
Globally, breast cancer accounts for one-fourth of new cancer cases in women and is also the leading cause of cancer and cancer death in women from low-middle-income countries. Cancer treatment is an expensive affair as it entails higher direct costs and increases indirect costs due to out-of-pocket expenditure and wage loss. It has been found that cancer treatment poses a huge economic burden on the household and results in catastrophic spending which further results in impoverishment of the household. The inequitable distribution of cancer care leads to inaccessibility and unaffordability thereby causing diagnostic delay and inability to receive timely cancer treatment. Prolongation of treatment duration increases the indirect cost of food, travel, and accommodation in addition to loss of productivity. This study will provide an opportunity to assess the incidence of financial toxicity in breast cancer patients from different countries with similar socio-demographic profiles. It will help correlate the risk of financial toxicity with the key quality parameters of the respective cancer diagnostic and treatment modalities. Secondly, the study also aims at assessing quality of life which will be captured using standard instruments. This study will not interfere with the standard treatment of breast cancer. The study team will interview the patient and/or the person accompanying them to capture details concerning social, economic, and living conditions, household income, and medical expenditure incurred for breast cancer treatment. The interview will be conducted during radiotherapy planning or delivery sessions. Single-time assessment of quality of life will also be done.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pathologically confirmed new invasive breast cancer cases b.
- •Invasive breast cancer (AJCC 8th edition) c.
- •Received multi-modality treatment with curative intent.
- •Patient willing to provide all estimates of expenditure before and after coming to the tertiary hospital, share relevant socio-demographic information and fill or respond to QOL instruments.
排除标准
- •Unable or unwilling to give written informed consent b.
- •Recurrent or metastatic disease.
结局指标
主要结局
Estimate of catastrophic health expenditure (CHE)
时间窗: Single interview at the time of radiotherapy treatment planning and review of medical records.
次要结局
- a. Proportion of quality indicators adversely affected(b. Study impact of FIT on quality of life using EQ5D5L and HADS.)
研究者
Dr Tabassum Wadasadawala
Tata Memorial Centre
