ColoRectal Cancer in India: catastrOphiC expenDIture and... | NCT04517032

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

NCT04517032

Sponsor

University of Birmingham

Status

Unknown status

Last Update Posted

Aug 18, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Colorectal Cancer
Treatment Compliance
Health Care Utilization

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Estimated

Primary Completion Date

Jan 1, 2022Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Aug 11, 2020

First Submission Date that Met QC Criteria

Aug 13, 2020

First Posted Date

Aug 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2020

Last Update Posted Date

Aug 18, 2020Actual

Name	Class
NIHR Research Unit on Global Surgery	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Catastrophic Expenditure at 3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aneel Bhangu, PhD	Contact	+44 (0) 121 3718121		aneel.bhangu@gmail.com
Joana Simoes, Master	Contact	+44 (0) 121 3718121		simoes.jff@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D010349	Patient Compliance
D010342	Patient Acceptance of Health Care

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided