Clinical trial NCT05357508: Colorectal Cancer Screening Based on Predicted Risk
Official title: Protocol Title: Colorectal Cancer Screening Decisions Based on Predicted Risk: the PREcision ScreENing Randomized Controlled Trial (PRESENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer Screening
Personalized Risk
Risk Communication
Shared Decision Making
Screening Behavior
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 515
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC.

The secondary objectives:

* Assess the feasibility of a subsequent larger RCT designed to detect a change in clinical outcomes;
* Explore the impact of psychological factors (perceived susceptibility for CRC, perceived benefits from and barriers to screening) on appropriate screening uptake and participation rates.

The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of participants' risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to a participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels.

This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance.

Detailed description: Colorectal cancer (CRC) can be effectively prevented by screening. Risk to develop CRC within 15 years is related to increasing age, sex, family history, and lifestyle and, thus, can vary from \<1% to \>15%.

Fecal immunochemical test (FIT) and colonoscopy are the most widely used screening tests. Colonoscopy is the most accurate test, but is related to risks of bleeding and perforation. Colonoscopy resources are limited, and high uptake of screening colonoscopy for low-risk individuals can cause long wait times for those with CRC symptoms or positive FIT. FIT is less costly can be done at home without preparation and, if done regularly, prevents most CRC mortality, especially in moderate and low-risk individuals. To offer the screening options with a reasonable risk-benefit balance, FIT should be recommended to individuals at low (\<3% to develop CRC in 15 years) and moderate (3-6%) risk, and colonoscopy to those at high (\>6%) risk.

The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC.

The secondary objectives:

* Assess the feasibility of a subsequent larger RCT designed to detect a change in clinical outcomes;
* Explore the impact of psychological factors (perceived susceptibility for CRC, perceived benefits from and barriers to screening) on appropriate screening uptake and participation rates.

The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of the participant's risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels.

This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance.

Eligibility criteria: Inclusion Criteria:

* Aged between 50 and 69;
* Residents of the Canton of Vaud;
* Have signed an informed consent (paper or electronic).

Exclusion Criteria:

* Current CRC symptoms;
* Personal CRC history;
* In colonoscopy surveillance for follow-up of high-risk polyp(s);
* Inflammatory bowel disease;
* Having done a colonoscopy within 9 years or a FIT within 1,5 years;
* Planning to leave Switzerland definitively within the next six months.

Primary outcomes:
measure: Self-reported appropriate screening uptake
timeFrame: 6-8 months after the intervention
Secondary outcomes:
measure: Self-reported overall screening participation
timeFrame: 6-8 months after the intervention
measure: Participation in the randomized trial
timeFrame: 6 weeks after mailed invitations
measure: Eligibility for the Vaud CRC screening program
timeFrame: 6 weeks after mailed invitations
measure: Self-reported anxiety
timeFrame: 6 weeks after mailed invitations
measure: Linkage to Vaud CRC screening program
timeFrame: 3-6 months after measurement of primary outcome
measure: Linkage to Vaud tumor registry
timeFrame: 6 months to 10 years after measurement of primary outcome
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Center for Primary Care and Public Health (Unisante)
state: Vaud
Study officials:
affiliation: Center for Primary Care and Public Health (Unisanté)
name: Kevin Selby, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hippisley-Cox J, Coupland C. Development and validation of risk prediction algorithms to estimate future risk of common cancers in men and women: prospective cohort study. BMJ Open. 2015 Mar 17;5(3):e007825. doi: 10.1136/bmjopen-2015-007825.
citation: Samusure J, Horisberger D, Diserens C, Ducros C, Auer R, Bodenmann P, Durand MA, Selby K. [Information materials for colorectal cancer screening for citizens with low health literacy]. Rev Med Suisse. 2022 Mar 30;18(775):616-620. doi: 10.53738/REVMED.2022.18.775.616. French.
citation: Plys E, Bulliard JL, Chaouch A, Durand MA, van Duuren LA, Brandle K, Auer R, Froehlich F, Lansdorp-Vogelaar I, Corley DA, Selby K. Colorectal Cancer Screening Decision Based on Predicted Risk: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 7;12:e46865. doi: 10.2196/46865.