Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia

Colorectal Cancer Clinical Trial

— ColonCancer  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785975
• Other study ID #: New Model of Care Hail Cluster
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: The New Model of Care, Hail Health Cluster
• Contact: Fakhralddin Elfakki, Reseach Lead
• Phone: +966530855161
• Email: abbasfakhraddin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2520
• Est. completion date: December 30, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 40 -75

Exclusion Criteria:

• Sever ill patient

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Saudi Arabia	Al Hait General Hospital Zone	Hail

Sponsors (1)

Lead Sponsor	Collaborator
The New Model of Care, Hail Health Cluster

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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