Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia (ColonCancer)

June 22, 2023 updated by: The New Model of Care, Hail Health Cluster

Effectiveness of Modified Integrated Colorectal Cancer Screening System: A Randomized Clustered Trial in Hail, Saudi Arabia.

In order to encourage the population at risk to participate in colorectal cancer screening, this clustered trial intends to determine the efficacy of specific messages(Nudge), single FIT testing, and the primary care physician's clinical judgment on referral to colonoscopy.

It primarily seeks to provide answers to the following questions: How effective is the modified integrated CRC screening system (MICRCSS) for individuals with average colorectal cancer risk? based on the percentage of individuals who had CRC screening, registered for the follow-up, and were discovered to have precancerous CRC issues a year after the program's start, as contrasted to individuals receiving standard medical care? All public government entities in the Hail region will be contacted with invitations to participate in the study (outreach). the organization

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Incidence of colorectal cancer (CRC), which starts in the innermost lining mucosa of the colon or rectum, is third (10.2%) in the globe behind lung and breast cancers (11,6%), according to the Global Cancer Observatory (GCO) 2018. According to a 2010 research, Saudi Arabia had an incidence of 10.4/100,000; regrettably, the incidence among young age groups is greater than that in countries with high incidence.

The majority of colorectal malignancies (CRCs) are first identified as polyps, which are small benign growths or projections seen inside the lumen of the colon. If a polyp is larger than 1 cm, if there are more than two polyps present, or if dysplasia is seen after the polyp is removed, the polyp is considered to be precancerous. Precancerous adenomas, hyperplastic polyps, or inflammatory polyps

Study Type

Interventional

Enrollment (Estimated)

2520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Amir Abdullatif, PCS Lead
  • Phone Number: 00966501277195

Study Locations

  • Saudi Arabia
      • Hail, Saudi Arabia, 12473
        • Recruiting
        • Al Hait General Hospital Zone
        • Contact:
          • Phone Number: 0530955161

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 40 -75

Exclusion Criteria:

  • Sever ill patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine Care for colorectal cancer screening
The comparators will be individuals with an average risk of colorectal cancer of both genders attending the selected health centres / or recruited through a community outreach approach.
Experimental: Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing
The intervention is an integrated system made up of single FIT testing, community outreach (landline call), and specific messages (Nudge). In order to encourage people to attend the screening, a primary care physician will be used in addition to text messages that participants at the outreach get for information, education, and communication (IEC).
Other: Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing
The intervention is an integrated system made up of single FIT testing, community outreach (landline call), and specific messages (Nudge). In order to encourage people to attend the screening, a primary care physician will be used in addition to text messages that participants at the outreach get for information, education, and communication (IEC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the CRC screening enrollment rates between the intervention and control groups.
Time Frame: 6 month from the start of the study
The proportion of people who had CRC screening who were included in the intervention group as opposed to the control group
6 month from the start of the study
To assess if positive subjects are complying with follow-up screening
Time Frame: 6 month from the start of the study
The proportion of participants in the intervention group compared to the control group who tested positive and underwent a colonoscopy as a follow-up.
6 month from the start of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The New Model of Care, Hail Health Cluster

Collaborators

Health Holding Company, Saudi Arabia
Hail Health Cluster, Saudi Arabia

Investigators

  • Study Chair: Khalil I Alshammari, VIP Chief MO, Hail Health Cluster
  • Study Director: Meshari Aljamaani, MOC Lead, New Model of Care, Hail Health Cluser
  • Principal Investigator: Fakhralddin A Elfakki, Research Lead, New Model of Care, Hail Health Cluster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

September 15, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • New Model of Care Hail Cluster

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The research outcome will be shared at the Saudi conference for pathway improvement

IPD Sharing Time Frame

September 2023

IPD Sharing Access Criteria

Data will be available in August 2023

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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