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

NCT ID: NCT04875793

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2022-07-10

Brief Summary

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.

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.

Conditions

Colorectal Neoplasms; Colorectal Cancer; Colonic Polyp; Occult Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups

Intervention Type: DIAGNOSTIC_TEST

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Facilitated appointment to receive a digestive health check and a comprehensive medical checkups

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ein Al-Hayat Medical Complex

UNKNOWN

Sponsor Role: collaborator

The Charitable Society for Health Care in Tabuk

UNKNOWN

Sponsor Role: collaborator

Ministry of Health, Saudi Arabia

OTHER_GOV

Sponsor Role: collaborator

Vision Health Consultancy Firm, Sudan

UNKNOWN

Sponsor Role: collaborator

University of Tabuk

OTHER

Sponsor Role: lead

Responsible Party

Fakhralddin Abbas Mohammed Elfakki

Assistant Professor of Preventive Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Public Primary Health Care Centers in the Tabuk City

Tabuk, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

TU-077/019/012

Identifier Type: -

Identifier Source: org_study_id