Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia

NCT05785975 | Unknown

• 1 other identifier: New Model of Care Hail Cluster
• Study Type: interventional
• Target: 2,520
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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

  6 month from the start of the study

• 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.

  6 month from the start of the study

Study Arms (2)

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

EXPERIMENTAL

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

Routine Care for colorectal cancer screening

NO INTERVENTION

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.

Interventions

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

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).

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

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 -75

You may not qualify if:

• Sever ill patient

Sponsors & Collaborators

• The New Model of Care, Hail Health Cluster: lead

Study Sites (1)

Al Hait General Hospital Zone

Hail, 12473, Saudi Arabia

RECRUITING

Related Publications (1)

• Elfakki FAM, Alshammari KI, Aljamani MY, Alshammari WI. A nudge strategy to increase the uptake of colorectal cancer screening in Saudi Arabia: A pragmatic randomized trial in the Hail region. J Family Med Prim Care. 2024 Jan;13(1):163-168. doi: 10.4103/jfmpc.jfmpc_966_23. Epub 2024 Feb 8.

  PMID: 38482290 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Khalil I Alshammari, VIP Chief MO

  Hail Health Cluster

  STUDY CHAIR

• Meshari Aljamaani, MOC Lead

  New Model of Care, Hail Health Cluser

  STUDY DIRECTOR

• Fakhralddin A Elfakki, Research Lead

  New Model of Care, Hail Health Cluster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fakhralddin Elfakki, Reseach Lead

CONTACT

+966530855161; abbasfakhraddin@gmail.com

Amir Abdullatif, PCS Lead

CONTACT

00966501277195

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 27, 2023
• Study Start: June 15, 2023
• Primary Completion: September 15, 2023
• Study Completion: December 30, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: September 2023
• Access Criteria: Data will be available in August 2023

Locations

SA (1)