Colorectal CancerCROCODILENCT04517032
ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment
An observational study of Colorectal Cancer and Treatment Compliance, run by University of Birmingham.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Treatment Compliance, Health Care Utilization
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made.
Who may be able to join
- 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
Who cannot join
- Patients with no histopathology available
- Telephone follow-up not possible
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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:
- 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.
- Medical subject headings
- Colorectal Neoplasms, Patient Compliance, Patient Acceptance of Health Care
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months after treatment decision
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after treatment decision
Identification of the main drivers of treatment cost
5 most expensive items or services during colorectal cancer treatment
Measured: 6 months after treatment decision
Colorectal cancer stage at the time of diagnosis
AJCC (American Joint Committee on Cancer) guidance - 8th edition
Measured: At the time of colorectal cancer diagnosis (coincident with timing of patient enrolment in the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- NIHR Research Unit on Global Surgery
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517032
- Sponsor's protocol ID
- CROC-20200503
- Acronym
- CROCODILE
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment
- ClinicalTrials.gov ID
- NCT04517032
- Acronym / sponsor ID
- CROCODILE / CROC-20200503
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- NIHR Research Unit on Global Surgery
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made.
Key inclusion criteria (6 listed)
- Adults aged 18+ years old. AND
- Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made:
- AND
- Undergoing treatment in the hospital where the MDT took place
Key exclusion criteria (2 listed)
- Patients with no histopathology available
- Telephone follow-up not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Catastrophic Expenditure at 6 months
Time frame: 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).
7 secondary outcomes
Catastrophic Expenditure at 6 weeks
Time frame: 6 weeks after treatment decision
Catastrophic Expenditure at 3 months
Time frame: 3 months after treatment decision
Treatment compliance at 6 weeks
Time frame: 6 weeks after treatment decision
Treatment compliance at 3 months
Time frame: 3 months after treatment decision
Treatment compliance at 6 months
Time frame: 6 months after treatment decision
Identification of the main drivers of treatment cost
Time frame: 6 months after treatment decision
Colorectal cancer stage at the time of diagnosis
Time frame: At the time of colorectal cancer diagnosis (coincident with timing of patient enrolment in the study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Treatment Compliance, run by University of Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aneel Bhangu, PhD (+44 (0) 121 3718121, aneel.bhangu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catastrophic Expenditure at 6 months (time frame: 6 months after treatment decision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.