ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment
CROCODILE
1 other identifier
observational
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 18, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedAugust 18, 2020
August 1, 2020
1 year
August 11, 2020
August 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Catastrophic Expenditure at 6 weeks
6 weeks after treatment decision
Catastrophic Expenditure at 3 months
3 months after treatment decision
Treatment compliance at 6 weeks
6 weeks after treatment decision
Treatment compliance at 3 months
3 months after treatment decision
Treatment compliance at 6 months
6 months after treatment decision
- +2 more secondary outcomes
Eligibility Criteria
Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made.
You may qualify if:
- 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
You may not qualify if:
- Patients with no histopathology available
- Telephone follow-up not possible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Birminghamlead
- NIHR Research Unit on Global Surgerycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
August 18, 2020
Study Start
January 1, 2021
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
August 18, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share