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

NCT ID: NCT04517032

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-01-01

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Treatment Compliance Health Care Utilization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NIHR Research Unit on Global Surgery

UNKNOWN

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Aneel Bhangu, PhD

Role: CONTACT

+44 (0) 121 3718121

Joana Simoes, Master

Role: CONTACT

+44 (0) 121 3718121

Other Identifiers

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CROC-20200503

Identifier Type: -

Identifier Source: org_study_id

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