ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment (CROCODILE)
2020年8月13日 更新者：University of Birmingham
Observational study to assess barriers for colorectal cancer treatment compliance in India, including quantitative assessment of catastrophic expenditure incidence and qualitative assessment of financial and non-financial barriers.
研究概览
详细说明
Objective: To identify a vulnerable group of colorectal cancer patients in India who cannot afford or are unable to comply with a treatment plan for colorectal cancer.
Aims:
- To identify the proportion of CRC patients suffering catastrophic expenditure due to out-of-pocket payments for cancer treatment.
- To determine the proportion of patients who are unable to comply with the treatment plan for CRC, at 6 weeks, 3 months and 6 months after diagnosis.
- To identify barriers and solutions to CRC treatment compliance. Design: A mixed-methods study comprising quantitative pilot data from 3 tertiary cancer centres and qualitative work from interviews with patients and healthcare professionals.
Participants: Patients diagnosed with primary colorectal cancer.
Outcomes:
Primary outcome:
• Incidence of catastrophic expenditure due to out-of-pocket payments for cancer care at 3 timepoints: 6 weeks, 3 months and 6 months after CRC diagnosis.
Secondary outcomes:
- Compliance to the initial treatment plan at three timepoints: 6 weeks, 3 months and 6 months after CRC diagnosis.
- Patients and healthcare professionals perspectives on patient compliance to CRC treatment.
- Identify the 5 main drivers (items charged to the patient) of CRC treatment cost.
- Colorectal cancer stage at the time of diagnosis.
研究类型
观察性的
注册 (预期的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made.
描述
Inclusion Criteria
- Adults aged 18+ years old. AND
Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made:
- In an multi-disciplinary team meeting (MDT);
- OR in the outpatient clinic where an MDT is not available (surgery, oncology or radiotherapy outpatient clinic).
AND
• Undergoing treatment in the hospital where the MDT took place
Exclusion Criteria
- Patients with no histopathology available
- Telephone follow-up not possible
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Catastrophic Expenditure at 6 months
大体时间：6 months after treatment decision
|
Catastrophic expenditure (CE) will be defined as out of pocket payments for CRC treatment greater than 40% of patient income (assessed by an in-person questionnaire led by a researcher).
|
6 months after treatment decision
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Catastrophic Expenditure at 6 weeks
大体时间：6 weeks after treatment decision
|
Catastrophic expenditure (CE) will be defined as out of pocket payments for CRC treatment greater than 40% of patient income (assessed by an in-person questionnaire led by a researcher).
|
6 weeks after treatment decision
|
|
Catastrophic Expenditure at 3 months
大体时间：3 months after treatment decision
|
Catastrophic expenditure (CE) will be defined as out of pocket payments for CRC treatment greater than 40% of patient income (assessed by an in-person questionnaire led by a researcher).
|
3 months after treatment decision
|
|
Treatment compliance at 6 weeks
大体时间：6 weeks after treatment decision
|
A compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.
|
6 weeks after treatment decision
|
|
Treatment compliance at 3 months
大体时间：3 months after treatment decision
|
A compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.
|
3 months after treatment decision
|
|
Treatment compliance at 6 months
大体时间：6 months after treatment decision
|
A compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.
|
6 months after treatment decision
|
|
Identification of the main drivers of treatment cost
大体时间：6 months after treatment decision
|
5 most expensive items or services during colorectal cancer treatment
|
6 months after treatment decision
|
|
Colorectal cancer stage at the time of diagnosis
大体时间：At the time of colorectal cancer diagnosis (coincident with timing of patient enrolment in the study)
|
AJCC (American Joint Committee on Cancer) guidance - 8th edition
|
At the time of colorectal cancer diagnosis (coincident with timing of patient enrolment in the study)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2021年1月1日
初级完成 (预期的)
2022年1月1日
研究完成 (预期的)
2022年1月1日
研究注册日期
首次提交
2020年8月11日
首先提交符合 QC 标准的
2020年8月13日
首次发布 (实际的)
2020年8月18日
研究记录更新
最后更新发布 (实际的)
2020年8月18日
上次提交的符合 QC 标准的更新
2020年8月13日
最后验证
2020年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.