Effectiveness of an Integrated Colorectal Cancer Screening in Saudi Arabia: A Pragmatic Randomized Trial (CRCScreen)

Effectiveness of an Integrated Colorectal Cancer Screening System in Saudi Arabia: A Pragmatic Randomized Trial

The global burden of colorectal cancer (CRC) incidence among young age groups is rising and overwhelming. This new trend of young-onset CRC incidence is evident in western countries. Unfortunately, Asian countries have shown the same epidemic shift in the past few years. As a consequence, this situation might necessitate revisiting the current screening program in this region.

Saudi Arabia has a two-fold increase in CRC incidence among young age groups in the last 18 years (9.6/100000 for male versus 9.3/100000 for female). This rising incidence ascribed to the lack of a screening program and suggested lowering CRC screening to 40.

The low awareness about risk factors, signs, and symptoms of the disease causes late presentation of CRC cases. Therefore, most presenting cases are associated with a poor prognosis and short survival. Educational and screening programs are, by no means, considered valuable and essential as CRC tends to affect younger age groups.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Colonic Polyp; Occult Bleeding
• Intervention / Treatment: Diagnostic test: Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups

Detailed Description

CRC is cancer that starts in the innermost lining mucosa of the colon or rectum. According to the global cancer Observatory (GCO) 2018, CRC incidence is the third (10.2%) globally, after lung and breast cancers (11.6%). In Saudi Arabia, 2010 report, the incidence was 10.4/100,000 that slightly higher in male groups. Unfortunately, the incidence among young age groups is more than that in countries with high incidence.

Most of the CRCs initially found as small benign growth or projections known as polyps inside the lumen of colorectal space. A polyp is precancerous if it is >1 cm or the presence of more than two polyps, or if dysplasia present after the polyp removal. There are two main types of polyps: precancerous and hyperplastic polyps or inflammatory polyps, which are not precancerous. The early resection will prevent future cancer development and total cure.

Different lifestyle factors that could increase CRC's risk include lack of regular physical exercise, a diet low in fruit and vegetables, a low-fibre and high-fat diet, diary intake during adolescence, overweight and obesity, alcohol consumption and tobacco use. Adherence to CRC screening is essential to limit CRC cancer incidence and improve population health; and then, health providers need to understand the stages of the disease to recommend effective screening strategies.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Tabuk, Saudi Arabia, 71491
    • Public Primary Health Care Centers in the Tabuk City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The participants will be individuals with an average risk of colorectal cancer, age: 40 years and above of both genders

Exclusion Criteria:

• Individuals age less than 40 years or severely ill individuals

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: List of health centers that randomly allocated to receive the intervention; The intervention is the integrated system which is composed of psychologist, endoscopy physician, family physician, community outreach, and audiovisuals in the waiting area. In addition to text messages of information, education and communication (IEC) delivered to the participants at the outreach, and education campaigns to mobilize individuals going for screening.	Diagnostic test: Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups; participants will be drawn from all public government institutions inside Tabuk city(outreach). The institution head will be requested to give wellness cards to the eligible employee to receive comprehensive testing for free in addition to CRC test in selected public health centres.; Other Names: Facilitated appointment to receive a digestive health check and a comprehensive medical checkups
No Intervention: List of health centers that randomly allocated to receive routine care; The comparators will be individuals with an average risk of colorectal cancer of both genders attending the randomly selected health centres

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of individuals who screened positive in the intervention group vs. control group.	The comparison of rate positive screening between the intervention and routine care	1 - 12 months
The enrollment rate of individuals who underwent CRC screening in the intervention group vs. control group	The comparison of the enrollment rate between the intervention and routine care	1 - 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of individuals who screened positive and enrolled in colonoscopy for follow-up in the intervention group vs. control group.	Per cent of enrollment in colonoscopy appointment and future follow-up	1 - 12 months

Collaborators and Investigators

• Sponsor: University of Tabuk
• Collaborators: Ministry of Health, Saudi Arabia; Ein Al-Hayat Medical Complex; The Charitable Society for Health Care in Tabuk; Vision Health Consultancy Firm, Sudan

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: May 1, 2021
• First Submitted That Met QC Criteria: May 1, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Polyps; Intestinal Polyps; Colorectal Neoplasms; Colonic Polyps
• Other Study ID Numbers: TU-077/019/012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No