Clinical trial NCT04517032: ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment
Official title: ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Treatment Compliance
Health Care Utilization
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: NIHR Research Unit on Global Surgery
First posted: 2020-08-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made.

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.

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:

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.

Eligibility 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

Primary outcomes:
measure: Catastrophic Expenditure at 6 months
timeFrame: 6 months after treatment decision
Secondary outcomes:
measure: Catastrophic Expenditure at 6 weeks
timeFrame: 6 weeks after treatment decision
measure: Catastrophic Expenditure at 3 months
timeFrame: 3 months after treatment decision
measure: Treatment compliance at 6 weeks
timeFrame: 6 weeks after treatment decision
measure: Treatment compliance at 3 months
timeFrame: 3 months after treatment decision
measure: Treatment compliance at 6 months
timeFrame: 6 months after treatment decision
measure: Identification of the main drivers of treatment cost
timeFrame: 6 months after treatment decision
measure: Colorectal cancer stage at the time of diagnosis
timeFrame: At the time of colorectal cancer diagnosis (coincident with timing of patient enrolment in the study)
Other outcomes:
Locations:
Study officials:
References: