Colorectal CancerColonCancerNCT05785975
Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia
A study testing Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing in people with Colorectal Cancer and Colorectal Neoplasms, run by The New Model of Care, Hail Health Cluster at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms
- What is being tested?
- Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,520 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jun 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40 -75
Who cannot join
- Sever ill patient
Trial locations and contacts
1 site in 1 country.
Amir Abdullatif, PCS Lead contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
Al Hait General Hospital Zone
Ha'il, 12473
0530955161
About this study
Official title: Effectiveness of Modified Integrated Colorectal Cancer Screening System: A Randomized Clustered Trial in Hail, Saudi Arabia.
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
Read the 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
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Being tested
- Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certain ommunications(Nudge), community-outreach(landline call), and single FIT testingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 6 month from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start15 Jun 2023
- Primary completion15 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 2,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New Model of Care, Hail Health Cluster
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Khalil I Alshammari, VIP Chief MO, Study chair, The New Model of Care, Hail Health ClusterMeshari Aljamaani, MOC Lead, Study director, New Model of Care, Hail Health CluserFakhralddin A Elfakki, Research Lead, Principal investigator, New Model of Care, Hail Health Cluster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785975
- Sponsor's protocol ID
- New Model of Care Hail Cluster
- Acronym
- ColonCancer
- Status last verified
- Jun 2023
- First submitted
- 27 Feb 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research outcome will be shared at the Saudi conference for pathway improvement
Publications
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.
PubMed 38482290
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Modified Integrated Colorectal Cancer Screening System: A Randomized Clustered Trial in Hail, Saudi Arabia.
- ClinicalTrials.gov ID
- NCT05785975
- Acronym / sponsor ID
- ColonCancer / New Model of Care Hail Cluster
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,520 participants (estimated)
- Lead sponsor
- The New Model of Care, Hail Health ClusterOther government
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing | Experimental | Other: Certain ommunications(Nudge), community-outreach(landline call), and single FIT testingThe 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 | 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 40 -75
Key exclusion criteria (1 listed)
- Sever ill patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certain ommunications(Nudge), community-outreach(landline call), and single FIT testingThe 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 |
Primary outcome
To compare the CRC screening enrollment rates between the intervention and control groups.
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Derived from this study: PubMed 38482290Elfakki 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.
- Individual participant dataSharing planned: Yes. The research outcome will be shared at the Saudi conference for pathway improvement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Abdullatif, PCS Lead contact
Khalil I Alshammari, VIP Chief MO study chair
The New Model of Care, Hail Health Cluster
Meshari Aljamaani, MOC Lead study director
New Model of Care, Hail Health Cluser
Fakhralddin A Elfakki, Research Lead principal investigator
New Model of Care, Hail Health Cluster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Certain ommunications(Nudge), community-outreach(landline call), and single FIT testing in people with Colorectal Cancer and Colorectal Neoplasms, run by The New Model of Care, Hail Health Cluster at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fakhralddin Elfakki, Reseach Lead (+966530855161, abbasfakhraddin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the CRC screening enrollment rates between the intervention and control groups. (time frame: 6 month from the start of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05785975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.