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

NCT04875793 | Completed

• 1 other identifier: TU-077/019/012
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms; Colorectal Cancer; Colonic Polyp; Occult Bleeding

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The percentage of individuals who screened positive and enrolled in colonoscopy for follow-up in the intervention group vs. control group.

  1 - 12 months

Study Arms (2)

List of health centers that randomly allocated to receive the intervention

EXPERIMENTAL

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

List of health centers that randomly allocated to receive routine care

NO INTERVENTION

The comparators will be individuals with an average risk of colorectal cancer of both genders attending the randomly selected health centres

Interventions

Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups 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.

Also known as: Facilitated appointment to receive a digestive health check and a comprehensive medical checkups

List of health centers that randomly allocated to receive the intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Individuals age less than 40 years or severely ill individuals

Sponsors & Collaborators

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

Study Sites (1)

Public Primary Health Care Centers in the Tabuk City

Tabuk, 71491, Saudi Arabia

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Interventions

Defecation; Occult Blood; Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Preventive Medicine and Epidemiology

Model Details: List of health centres that randomly allocated to receive the intervention

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 6, 2021
• Study Start: June 10, 2021
• Primary Completion: June 10, 2022
• Study Completion: July 10, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

SA (1)