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Trial Title:
Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia
NCT ID:
NCT05785975
Condition:
Colorectal Cancer
Colorectal Neoplasms
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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. 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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing
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 group label:
Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 40 -75
Exclusion Criteria:
- Sever ill patient
Gender:
All
Minimum age:
40 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Al Hait General Hospital Zone
Address:
City:
Hail
Zip:
12473
Country:
Saudi Arabia
Status:
Recruiting
Contact:
Phone:
0530955161
Start date:
June 15, 2023
Completion date:
December 30, 2023
Lead sponsor:
Agency:
The New Model of Care, Hail Health Cluster
Agency class:
Other
Source:
The New Model of Care, Hail Health Cluster
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05785975
