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Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia (ColonCancer)

Primary Purpose

Colorectal Cancer, Colorectal Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing
Sponsored by
The New Model of Care, Hail Health Cluster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 40 -75 Exclusion Criteria: Sever ill patient

Sites / Locations

  • Al Hait General Hospital ZoneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing

Routine Care for colorectal cancer screening

Arm Description

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).

The comparators will be individuals with an average risk of colorectal cancer of both genders attending the selected health centres / or recruited through a community outreach approach.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2023
Last Updated
June 22, 2023
Sponsor
The New Model of Care, Hail Health Cluster
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1. Study Identification

Unique Protocol Identification Number
NCT05785975
Brief Title
Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia
Acronym
ColonCancer
Official Title
Effectiveness of Modified Integrated Colorectal Cancer Screening System: A Randomized Clustered Trial in Hail, Saudi Arabia.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The New Model of Care, Hail Health Cluster

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
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
Detailed 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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention is an integrated system built on the concept of nudging and made up of a trained family doctor, community outreach (using landline calls, and a single FIT test for occult blood. Together with the information, education, and communication (IEC) texts that were sent to the outreach participants by SMS. four screening healthcare zones that included 34 public primary care facilities in the Hail region. The total sample size for the two trial arms is 2520 individuals. The calculation was done using the STATA version 15 data analysis software, the sample size command, and the cluster sizes of m1 = (60), m2 = (60), a control-group rate of (0.4), an experimental group rate of (0.6), the intraclass correlation coefficient (rho) of (0.02), a power beta of (0.8), and a sample of N1 = (1260), N2 = (1260).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing
Arm Type
Experimental
Arm Description
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).
Arm Title
Routine Care for colorectal cancer screening
Arm Type
No Intervention
Arm Description
The comparators will be individuals with an average risk of colorectal cancer of both genders attending the selected health centres / or recruited through a community outreach approach.
Intervention Type
Other
Intervention Name(s)
Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing
Intervention Description
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).
Primary Outcome Measure Information:
Title
To compare the CRC screening enrollment rates between the intervention and control groups.
Description
The proportion of people who had CRC screening who were included in the intervention group as opposed to the control group
Time Frame
6 month from the start of the study
Title
To assess if positive subjects are complying with follow-up screening
Description
The proportion of participants in the intervention group compared to the control group who tested positive and underwent a colonoscopy as a follow-up.
Time Frame
6 month from the start of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 40 -75 Exclusion Criteria: Sever ill patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fakhralddin Elfakki, Reseach Lead
Phone
+966530855161
Email
abbasfakhraddin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Abdullatif, PCS Lead
Phone
00966501277195
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalil I Alshammari, VIP Chief MO
Organizational Affiliation
Hail Health Cluster
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Meshari Aljamaani, MOC Lead
Organizational Affiliation
New Model of Care, Hail Health Cluser
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fakhralddin A Elfakki, Research Lead
Organizational Affiliation
New Model of Care, Hail Health Cluster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Hait General Hospital Zone
City
Hail
ZIP/Postal Code
12473
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
Phone
0530955161

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The research outcome will be shared at the Saudi conference for pathway improvement
IPD Sharing Time Frame
September 2023
IPD Sharing Access Criteria
Data will be available in August 2023

Learn more about this trial

Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia

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