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Clinical Trials/NCT05785975
NCT05785975
Recruiting
Not Applicable

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

The New Model of Care, Hail Health Cluster1 site in 1 country2,520 target enrollmentJune 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
The New Model of Care, Hail Health Cluster
Enrollment
2520
Locations
1
Primary Endpoint
To compare the CRC screening enrollment rates between the intervention and control groups.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
June 15, 2023
End Date
December 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The New Model of Care, Hail Health Cluster
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 40 -75

Exclusion Criteria

  • Sever ill patient

Outcomes

Primary Outcomes

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

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.

Study Sites (1)

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