Condition category
Cancer
Date applied
15/04/2019
Date assigned
19/04/2019
Last edited
18/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Colorectal cancer incidence is the third, globally, after lung and breast cancer; unfortunately, there is rising incidence, especially among young age groups in Saudi Arabia in the last 18 years due to changes in diet that mimic western countries. On the other hand, there is a great gap in the screening service that matches the current context in Saudi Arabia; this is reflected by the lack of a well-structured screening service that encourages participation and adherence. Low awareness about the importance of screening, fear of cancer, and the absence of a clear vision on how to implement and provide the service are the main obstacles for a successful screening program. This study aims to test the effectiveness of a new system for colorectal cancer screening composed of an integrated network of professionals. This system is expected to facilitate participation by providing psychological support, health education and testing at the health facility level and outreach using community mobilization, health education campaigns, and media.

Who can participate?
Individuals of both genders, aged 40 and over, who are at risk of colorectal cancer attending the selected hospitals (King Fahad and King Khalid Hospitals in Tabuk) in addition to 18 public health centers

What does the study involve?
Participating facilities are randomly allocated to either the intervention or the control group. The control group receive routine care. The intervention is an integrated system composed of a psychologist, an endoscopy physician, a family physician, and audiovisuals in the waiting area; in addition to text messages of information, education and communication (IEC) delivered to the participants at the hospital center, outreach, and education campaigns in order to mobilize the individuals going for screening. Trained health staff provide counseling and education; likewise, well-designed IEC materials and videos are displayed on the waiting area screen, as well as social media and short text messages. Participants attend two counseling and educational sessions: an initial session with a psychologist to educate participants on the importance of the screening and to discuss the screening methods; illiterate participants are given pictorial IEC messages. Experts in IEC prepare and pilot all materials.

What are the possible benefits and risks of participating?
Participants receive a free integrated screening service (counseling, education, and testing for colorectal cancer). No harms or risks are expected.

Where is the study run from?
University of Tabuk (Saudi Arabia)

When is the study starting and how long is it expected to run for?
June 2019 to September 2022

Who is funding the study?
1. Ministry of Education (Saudi Arabia)
2. University of Tabuk (Saudi Arabia)
3. Ain Alhayt Medical Center, Tabuk (Saudi Arabia)

Who is the main contact?
Dr Fakhralddin Elfakki
f-elfakki@ut.edu.sa

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fakhralddin Elfakki

ORCID ID

Contact details

Tabuk University
Doba Street
PO Box 741
Tabuk
71491
Saudi Arabia
+966 (0)535817539
f-elfakki@ut.edu.sa

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Effectiveness of a new integrated colorectal cancer screening system in Saudi Arabia: a randomized clustered trial

Acronym

Study hypothesis

Hypothesis 2: H0: There is no difference in the detection rate between the intervention groups that use ICRCSS and the control group that use routine care.
Hypothesis 1: H0: The application of an ICRCSS at the public hospital centers has no effect on supporting, educating, and mobilizing people with average risk participating colorectal cancer screening.

Ethics approval

Approval pending, University of Tabuk Ethics Research Committee

Study design

Clustered double-blinded randomized trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Colorectal cancer

Intervention

Randomization:
Participants will be randomly allocated to either the intervention or the control group. The study will cover the big two public hospitals (King Fahad and Ain Alhayat Hospitals) and all health centers in Tabuk city (18 health centers). Cluster-based randomization will be generated and each trial arm is composed of 10 clusters selected from a list of 18 health centers and two big hospitals. Random number generator software is used from: https://www.random.org/. The randomization will be held centrally by the research team and selected health centers will be identified prior to the starting date of the trial. Selected centers will be maintained throughout the trial and no change is allowed. Contacts will be held with the selected health centers authorities to obtain permission. Half of the facilities will be the intervention sites and the other half will be the control sites with no intervention.

Intervention:
The intervention is an integrated system composed of a psychologist, an endoscopy physician, a family physician, and audiovisuals in the waiting area; in addition to text messages of information, education and communication (IEC) delivered to the participants at the hospital center, outreach, and education campaigns in order to mobilize the individuals going for screening; there are 18 public primary health care centers in the Tabuk city that will be used for both intervention and control groups. Eligible people from the Saudi Public Pension Agency (PPA) in the Tabuk will be mobilized to participate in the study. Trained health staff will provide counseling and education; likewise, well-designed IEC materials and videos to be visualized on the waiting area screen, as well as social media and short text messages. Participants are planned to attend two counseling and educational sessions: an initial session with a psychologist to educate participants on the importance of the screening and to discuss the screening methods; illiterate participants will be given pictorial IEC messages. Experts in IEC will prepare and pilot all materials.

Comparators:
The comparators will be individuals with risk of colorectal cancer of both genders attending the selected hospital center at (King Fahad or Ain Alhayat private hospital plus 9 public health centers in Tabuk) receiving routine care.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

The effectiveness of an Integrated Colo-rectal Cancer Screening System (ICRCSS) as measured by the percentage of individuals with average risk of CRC who:
1. Underwent CRC screening
2. Enrolled for follow-up after screening
3. Screened positive for signs of a precancerous CRC condition
compared with individuals receiving routine care at 3 years after the start of the program.

Secondary outcome measures

The effectiveness of an Integrated Colo-rectal Cancer Screening System (ICRCSS) as measured by the percentage of individuals with a high risk of CRC who:
1. Underwent CRC screening
2. Enrolled for follow-up after screening
3. Screened positive for signs of a precancerous CRC condition
compared with individuals receiving routine care at 3 years after the start of the program.

Overall trial start date

01/06/2019

Overall trial end date

01/09/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Individuals of both genders at risk of colorectal cancer attending the selected hospitals (King Fahad Hospital and Ain Alhayat Medical Center in Tabuk) in addition to 18 public health centers
2. Aged 40 years and above
3. Saudi citizens and non-Saudis who are eligible to receive free public health services. Those who are not eligible to use the free public health service will be excluded
4. The participants will be interviewed at the start to collect baseline data about their risk of colorectal cancer

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

440

Participant exclusion criteria

1. Those who are not eligible to use the free public health service in the Kingdom of Saudi Arabia
2. Patients who are already diagnosed or under follow-up with colorectal cancer care

Recruitment start date

01/09/2019

Recruitment end date

01/12/2019

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

University of Tabuk
Doba Street PO Box 741
Tabuk
71491
Saudi Arabia

Sponsor information

Funders

Funder type

Government

Funder name

Ministry of Education Saudi Arabia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Tabuk

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ain Alhayt Medical Center, Tabuk

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A systematic review plus three to four publications on the trial outcomes and experience will be published in a high impact journal in order to share knowledge with others who are concerned with the development of screening programs all over the globe.

IPD sharing statement
The datasets generated during and/or analyzed during the current study will be available upon request from Fakhralddin Abbas Elfakki (abbasfakhraddin@gmail.com). The data will be available after three months of the start of the trial.

Intention to publish date

01/09/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/04/2019: Trial's existence confirmed by Ain Alhayt Medical Center.