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

Primary Purpose

Colorectal Neoplasms, Colorectal Cancer, Colonic Polyp

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups
Sponsored by
University of Tabuk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasms

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Public Primary Health Care Centers in the Tabuk City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

List of health centers that randomly allocated to receive the intervention

List of health centers that randomly allocated to receive routine care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
May 1, 2021
Last Updated
December 6, 2022
Sponsor
University of Tabuk
Collaborators
Ein Al-Hayat Medical Complex, The Charitable Society for Health Care in Tabuk, Ministry of Health, Saudi Arabia, Vision Health Consultancy Firm, Sudan
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1. Study Identification

Unique Protocol Identification Number
NCT04875793
Brief Title
Effectiveness of an Integrated Colorectal Cancer Screening in Saudi Arabia: A Pragmatic Randomized Trial
Acronym
CRCScreen
Official Title
Effectiveness of an Integrated Colorectal Cancer Screening System in Saudi Arabia: A Pragmatic Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
July 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tabuk
Collaborators
Ein Al-Hayat Medical Complex, The Charitable Society for Health Care in Tabuk, Ministry of Health, Saudi Arabia, Vision Health Consultancy Firm, Sudan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Colorectal Cancer, Colonic Polyp, Occult Bleeding

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
List of health centres that randomly allocated to receive the intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
List of health centers that randomly allocated to receive the intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
List of health centers that randomly allocated to receive routine care
Arm Type
No Intervention
Arm Description
The comparators will be individuals with an average risk of colorectal cancer of both genders attending the randomly selected health centres
Intervention Type
Diagnostic Test
Intervention Name(s)
Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups
Other Intervention Name(s)
Facilitated appointment to receive a digestive health check and a comprehensive medical checkups
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percentage of individuals who screened positive in the intervention group vs. control group.
Description
The comparison of rate positive screening between the intervention and routine care
Time Frame
1 - 12 months
Title
The enrollment rate of individuals who underwent CRC screening in the intervention group vs. control group
Description
The comparison of the enrollment rate between the intervention and routine care
Time Frame
1 - 12 months
Secondary Outcome Measure Information:
Title
The percentage of individuals who screened positive and enrolled in colonoscopy for follow-up in the intervention group vs. control group.
Description
Per cent of enrollment in colonoscopy appointment and future follow-up
Time Frame
1 - 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Public Primary Health Care Centers in the Tabuk City
City
Tabuk
ZIP/Postal Code
71491
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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