Colorectal Cancer Screening Based on Predicted Risk

NCT05357508 | Completed

• 1 other identifier: PRESENT STUDY
• Study Type: interventional
• Target: 515
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer Screening; Personalized Risk; Risk Communication; Shared Decision Making; Screening Behavior

Outcome Measures

Primary Outcomes (1)

• Self-reported appropriate screening uptake

  Proportion who completed screening test appropriate to risk level. For low risk (\<3% 15-yr CRC risk), completing a FIT. For intermediate risk (3-6%15-yr CRC risk), completing a FIT, completing a colonoscopy, or having a colonoscopy appointment. For high risk (\>6% 15-yr CRC risk), completing a colonoscopy or having a colonoscopy appointment.

  6-8 months after the intervention

Secondary Outcomes (6)

• Self-reported overall screening participation

  6-8 months after the intervention

• Participation in the randomized trial

  6 weeks after mailed invitations

• Eligibility for the Vaud CRC screening program

  6 weeks after mailed invitations

• Self-reported anxiety

  6 weeks after mailed invitations

• Linkage to Vaud CRC screening program

  3-6 months after measurement of primary outcome

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the Intervention group receive a brochure with their personalized risk score for colorectal cancer and screening recommendations (FIT or colonoscopy) corresponding to their risk level.

Behavioral: Intervention brochure

Usual care group

ACTIVE COMPARATOR

Participants in the Usual care group receive the standard brochure designed by the Vaud screening program. This brochure recommends screening to all individuals beginning at age 50 and presents both FIT and colonoscopy as equal options.

Behavioral: Control brochure

Interventions

Intervention brochure BEHAVIORAL

Provide participants with information about their personalized risk for colorectal cancer and appropriate screening recommendations to facilitate their screening option choice.

Intervention group

Control brochure BEHAVIORAL

Provide participants with general information about options for colorectal cancer screening.

Usual care group

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: lead

Study Sites (1)

Center for Primary Care and Public Health (Unisante)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 25783428 BACKGROUND

• 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.

  PMID: 35353458 BACKGROUND

• 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.

  PMID: 37676720 BACKGROUND

• Plys E, Bulliard JL, Chaouch A, Durand MA, van Duuren LA, Braendle K, Auer R, Froehlich F, Lansdorp-Vogelaar I, Corley DA, Selby K. Colorectal Cancer Screening Based on Predicted Risk: A Randomized Controlled Trial. Am J Gastroenterol. 2025 Oct 1;120(10):2432-2439. doi: 10.14309/ajg.0000000000003311. Epub 2025 Jan 7.

  PMID: 39774118 DERIVED

Related Links

• Risk calculator used

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Kevin Selby, MD, MAS

  Center for Primary Care and Public Health (Unisanté)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 3, 2022
• Study Start: May 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Will become available upon publication of the primary results and remain available 5 years.
• Access Criteria: Reasonable request to the principal investigator

Locations

CH (1)