Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Colorectal Cancer, Colorectal Neoplasms

Intervention / Treatment
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* Other: Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 -75 Exclusion Criteria: Sever ill patient

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention is an integrated system built on the concept of nudging and made up of a trained family doctor, community outreach (using landline calls, and a single FIT test for occult blood. Together with the information, education, and communication (IEC) texts that were sent to the outreach participants by SMS. four screening healthcare zones that included 34 public primary care facilities in the Hail region. The total sample size for the two trial arms is 2520 individuals. The calculation was done using the STATA version 15 data analysis software, the sample size command, and the cluster sizes of m1 = (60), m2 = (60), a control-group rate of (0.4), an experimental group rate of (0.6), the intraclass correlation coefficient (rho) of (0.02), a power beta of (0.8), and a sample of N1 = (1260), N2 = (1260).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing<br>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<br>* 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).<br>|
| No Intervention: Routine Care for colorectal cancer screening<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the CRC screening enrollment rates between the intervention and control groups. | 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 | 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 |