ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment

Conditions
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Colorectal Cancer, Treatment Compliance, Health Care Utilization

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catastrophic Expenditure at 6 months | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catastrophic Expenditure at 6 weeks | 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 | 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 | 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 | 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 | 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 | 5 most expensive items or services during colorectal cancer treatment | 6 months after treatment decision | 
| Colorectal cancer stage at the time of diagnosis | 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) |