NCT04517032

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 11, 2020

Last Update Submit

August 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (7)

  • Catastrophic Expenditure at 6 weeks

    6 weeks after treatment decision

  • Catastrophic Expenditure at 3 months

    3 months after treatment decision

  • Treatment compliance at 6 weeks

    6 weeks after treatment decision

  • Treatment compliance at 3 months

    3 months after treatment decision

  • Treatment compliance at 6 months

    6 months after treatment decision

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with no histopathology available
  • Telephone follow-up not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsPatient CompliancePatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 18, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share