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

Colorectal Cancer Clinical Trial

— CROCODILE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04517032
• Other study ID #: CROC-20200503
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: August 2020
• Source: University of Birmingham
• Contact: Aneel Bhangu, PhD
• Phone: +44 (0) 121 3718121
• Email: aneel.bhangu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Health Care Utilization
• Treatment Compliance

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	NIHR Research Unit on Global Surgery

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Identification of the main drivers of treatment cost	5 most expensive items or services during colorectal cancer treatment	6 months after treatment decision
Secondary	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)