ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment
- Conditions
- Treatment ComplianceColorectal CancerHealth Care Utilization
- Registration Number
- NCT04517032
- Lead Sponsor
- University of Birmingham
- Brief Summary
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
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:
1. To identify the proportion of CRC patients suffering catastrophic expenditure due to out-of-pocket payments for cancer treatment.
2. 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.
3. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Catastrophic Expenditure at 6 months 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).
- Secondary Outcome Measures
Name Time Method Identification of the main drivers of treatment cost 6 months after treatment decision 5 most expensive items or services during colorectal cancer treatment
Colorectal cancer stage at the time of diagnosis 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
Catastrophic Expenditure at 6 weeks 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).
Catastrophic Expenditure at 3 months 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).
Treatment compliance at 6 weeks 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.
Treatment compliance at 3 months 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.
Treatment compliance at 6 months 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.