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

U

University of Birmingham

Status

Unknown

Conditions

Treatment Compliance
Health Care Utilization
Colorectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04517032
CROC-20200503

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial contacts and locations

0

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Central trial contact

Joana Simoes, Master; Aneel Bhangu, PhD

Data sourced from clinicaltrials.gov

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