Clinical trial NCT05785975: Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia
Official title: Effectiveness of Modified Integrated Colorectal Cancer Screening System: A Randomized Clustered Trial in Hail, Saudi Arabia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Colorectal Neoplasms
Lead sponsor: The New Model of Care, Hail Health Cluster
Sponsor class: OTHER_GOV
First posted: 2023-03-27
Enrollment: 2520
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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. 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).
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

* Age 40 -75

Exclusion Criteria:

* Sever ill patient

Primary outcomes:
measure: To compare the CRC screening enrollment rates between the intervention and control groups.
timeFrame: 6 month from the start of the study
measure: To assess if positive subjects are complying with follow-up screening
timeFrame: 6 month from the start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: Al Hait General Hospital Zone
Study officials:
affiliation: Hail Health Cluster
name: Khalil I Alshammari, VIP Chief MO
role: STUDY_CHAIR
affiliation: New Model of Care, Hail Health Cluser
name: Meshari Aljamaani, MOC Lead
role: STUDY_DIRECTOR
affiliation: New Model of Care, Hail Health Cluster
name: Fakhralddin A Elfakki, Research Lead
role: PRINCIPAL_INVESTIGATOR
References: