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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04517032
Acronym
CROCODILE
Enrollment
200
Registered
2020-08-18
Start date
2021-01-01
Completion date
2022-01-01
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Health Care Utilization, Treatment Compliance

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.

Interventions

None listed

Sponsors

NIHR Research Unit on Global Surgery
CollaboratorUNKNOWN
University of Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Catastrophic Expenditure at 6 months6 months after treatment decisionCatastrophic 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

MeasureTime frameDescription
Catastrophic Expenditure at 3 months3 months after treatment decisionCatastrophic 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 weeks6 weeks after treatment decisionA 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 months3 months after treatment decisionA compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.
Catastrophic Expenditure at 6 weeks6 weeks after treatment decisionCatastrophic 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).
Identification of the main drivers of treatment cost6 months after treatment decision5 most expensive items or services during colorectal cancer treatment
Colorectal cancer stage at the time of diagnosisAt the time of colorectal cancer diagnosis (coincident with timing of patient enrolment in the study)AJCC (American Joint Committee on Cancer) guidance - 8th edition
Treatment compliance at 6 months6 months after treatment decisionA compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.

Contacts

Primary ContactAneel Bhangu, PhD
aneel.bhangu@gmail.com+44 (0) 121 3718121
Backup ContactJoana Simoes, Master
simoes.jff@gmail.com+44 (0) 121 3718121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026