Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia
NCT ID: NCT05785975
Last Updated: 2023-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2520 participants
INTERVENTIONAL
2023-06-15
2023-12-30
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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).
PREVENTION
NONE
Study Groups
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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).
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).
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.
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
75 Years
ALL
Yes
Sponsors
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The New Model of Care, Hail Health Cluster
OTHER_GOV
Responsible Party
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Principal Investigators
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Khalil I Alshammari, VIP Chief MO
Role: STUDY_CHAIR
Hail Health Cluster
Meshari Aljamaani, MOC Lead
Role: STUDY_DIRECTOR
New Model of Care, Hail Health Cluser
Fakhralddin A Elfakki, Research Lead
Role: PRINCIPAL_INVESTIGATOR
New Model of Care, Hail Health Cluster
Locations
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Al Hait General Hospital Zone
Hail, , Saudi Arabia
Countries
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Central Contacts
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Amir Abdullatif, PCS Lead
Role: CONTACT
Facility Contacts
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Role: primary
References
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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.
Other Identifiers
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New Model of Care Hail Cluster
Identifier Type: -
Identifier Source: org_study_id
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