Catastrophic costs and expenditure and referral pathways influence treatment of Breast cancer in India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,030
- 试验地点
- 2
- 主要终点
- The primary outcome of this study will be catastrophic expenditure at 3 months, 6
研究概览
简要总结
Catastrophic costs and expenditure and referral pathways influence treatment of Breast cancer in India: (CROCODILE-B)
The aim of the study is to identify financial and non-financial barriers to comply with treatment for breast cancer in India. The study will be a mixed-methods study comprising quantitative data from up to 10 tertiary hospitals and qualitative work from interviews with patients and healthcare professionals where the outcome is the incidence of catastrophic expenditure due to out-of-pocket payments for cancer care at 3 months and 6 months and 1 year after breast cancer diagnosis. A mixed method study is being done as we are looking at identifying barriers to adherence to therapy as well as the patient’s ability to cope with the costs of treatment.
Study Setting and design: This study will be run in ten hospitals in India where cancer treatment is available and routinely delivered. This will be a prospective, multicentric, mixed-methods study with two main workstream: 1. Quantitative workstream: a prospective cohort study to determine the catastrophic expenditure 2. Qualitative workstream: to explore patient and professionals perspectives about the barriers to breast cancer treatment compliance.
The primary objective of this study is to identify the proportion of breast cancer patients suffering catastrophic expenditure due to out-of-pocket payments for cancer treatments. The secondary objectives are: 1. To assess the catastrophic expenditure rate at 3 months, 6 months and 1 year after diagnosis. 2. To identify the main drivers of treatment costs in breast cancer treatment.
Sample size: 1030 patients
Duration: 01 year 6 months
Statistical Analysis
All analyses will be conducted using the intention to treat (ITT) principle, which means that patients’ outcomes will be examined in relation to their initial treatment plan (surgery, chemotherapy, radiotherapy). Summary statistics will be supplied for all outcome measures using counts and percentages for categorical variables and means and standard deviations and/or medians and interquartile ranges for continuous variables. To test for differences across comparisons of categorical variables, the Chi square test will be utilized. Welch’s t-test or ANOVA will be used for continuous data that is parametric in character (as visually appraised). The Wilcoxon rank sum or Kruskall-Wallis tests will be employed for non-parametric data. All the analysis will be undertaken using the R studio software (v2023.12.0+369).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adult aged 18 years to 99 Years 2) Consecutive new patients with a histopathology proven breast cancer for whom a CRC treatment plan is made: o In a multi-disciplinary team meeting (MDT).
- •o OR in the outpatient clinic where an MDT is not available (surgery, chemotherapy, or radiation therapy outpatient clinic).
- •Undergoing treatment in the hospital where the MDT took place.
- •Participants must be able to provide written informed consent (signature or a fingerprint).
排除标准
- •Patients with no histopathology available.
- •Patients suffering from double primary cancers 3) Patients for whom a treatment plan is made at recurring hospitals who undergo the full course of treatment in another hospital will be excluded.
- •Patient on Palliative therapy 5) Telephone follow-up not possible.
结局指标
主要结局
The primary outcome of this study will be catastrophic expenditure at 3 months, 6
时间窗: The primary outcome of this study will be catastrophic expenditure at 3 months, 6 | months and 1 year after the treatment decision.
months and 1 year after the treatment decision.
时间窗: The primary outcome of this study will be catastrophic expenditure at 3 months, 6 | months and 1 year after the treatment decision.
次要结局
- 1. Treatment compliance rate at 3 months, 6 months and at 1 year after treatment(decision.)
研究者
Dr Deepak Jain
Christian Medical College & Hospital Ludhiana