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

Sponsor

The New Model of Care, Hail Health Cluster (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05785975

Collaborator

Health Holding Company, Saudi Arabia (Other), Hail Health Cluster, Saudi Arabia (Other)

440

Enrollment

Arms

7.5

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Colorectal Neoplasms	Other: Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

440 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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. There were also educational efforts to encourage people to go for screenings. 26 public primary healthcare facilities are available in Hail City, and both the intervention and control groups will be housed there.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. There were also educational efforts to encourage people to go for screenings. 26 public primary healthcare facilities are available in Hail City, and both the intervention and control groups will be housed there.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effectiveness of Modified Integrated Colorectal Cancer Screening System: A Randomized Clustered Trial in Hail, Saudi Arabia.

Anticipated Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

Sep 15, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing 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).	Other: Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing 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).
No Intervention: Routine Care for colorectal cancer screening 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.

Arm

Intervention/Treatment

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

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).

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

No Intervention: Routine Care for colorectal cancer screening

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.

Outcome Measures

Primary Outcome Measures

To compare the CRC screening enrollment rates between the intervention and control groups. [6 month from the start of the study]
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 [6 month from the start of the study]
The proportion of participants in the intervention group compared to the control group who tested positive and underwent a colonoscopy as a follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 40 -75

Exclusion Criteria:

Sever ill patient

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The New Model of Care, Hail Health Cluster
Health Holding Company, Saudi Arabia
Hail Health Cluster, Saudi Arabia

Investigators

Study Chair: Khalil I Alshammari, VIP Chief MO, Hail Health Cluster
Study Director: Meshari Aljamaani, MOC Lead, New Model of Care, Hail Health Cluser
Principal Investigator: Fakhralddin A Elfakki, Research Lead, New Model of Care, Hail Health Cluster

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The New Model of Care, Hail Health Cluster

ClinicalTrials.gov Identifier:

NCT05785975

Other Study ID Numbers:

New Model of Care Hail Cluster

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 28, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Mar 28, 2023