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临床试验/CTRI/2019/07/020142
CTRI/2019/07/020142已完成不适用

Health expenditure on breast cancer treatment in women: a study from public sector tertiarycancer centre

Womens cancer initiative1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2019年7月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
700
试验地点
1
主要终点
Estimation of direct cost and out of pocket (OOP) expenditure incurred by women for breast cancer treatment at public sector tertiary care hospital in India.

研究概览

简要总结

Breast cancer is the leading cause of cancer and cancer death in Indian women. Cancer treatment poses a huge economic burden over the household and results in impoverishment of the household. Till date no study in India has looked at the amount of expenditure that the household incurs for treatment of breast cancer. This study aims to collect data on expenditure of treatment of breast cancer for patients who are registered at Tata Memorial Centre (TMC) and undergoing active treatment at TMC. Secondly, the study also aims at measuring the well-being of women and is captured using standard instruments like the EQ 5D, WHODAS and EORTC QLQ 30 & BR23. The study will not interfere with the standard treatment for breast cancer. The study team members will interview the patient or the person accompanying her for obtaining household details on social, economic and living conditions, household consumption and medical expenditure. A detailed medical and treatment history that the patient would undergo at TMC will be recorded. In addition, a detailed record of the spending for treatment will be maintained on regular basis. Data will be collected over a period of one year in order to capture the treatment period entirely. Patients will also be served the three instruments as mentioned earlier to get information about the impact of cancer treatment on daily activities and quality of life.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Pathologically confirmed new invasive breast cancer cases 2) Non-metastatic invasive breast cancer (AJCC 8th edition) 3) Intending to receive entire treatment at TMC 4) Planned for multi-modality treatment comprising of surgery, chemotherapy and radiotherapy with or without hormone therapy or targeted therapy 5) Age > 18 years 6) Patient willing to provide all estimates of expenditure before and after coming to the tertiary hospital.
  • Patient willing to share relevant socio-demographic information.
  • Willing to fill or respond to QOL instruments.

排除标准

  • Unable or unwilling to give written informed consent 2) Inability to follow up after treatment completion.
  • Not willing for follow up till 2 years.
  • Recurrent or progressive disease.

结局指标

主要结局

Estimation of direct cost and out of pocket (OOP) expenditure incurred by women for breast cancer treatment at public sector tertiary care hospital in India.

时间窗: After the last accrued patient completes entire treatment

次要结局

  • 1) Mean difference in expenditure in INR between two categories of patients (general and private)(2) Proportion of patients in each category experiencing catastrophic expenditure (expenditure exceeding 10% of household income) in different cohorts.)

研究者

发起方
Womens cancer initiative
申办方类型
Other [ngo]

研究点 (1)

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