Colorectal Cancer Screening Based on Predicted Risk (PRESENT)

Protocol Title: Colorectal Cancer Screening Decisions Based on Predicted Risk: the PREcision ScreENing Randomized Controlled Trial (PRESENT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Intervention brochure; Behavioral: Control brochure

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.

• Study Type: Interventional
• Enrollment (Actual): 515
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin Selby, MD, MAS; Phone Number: +41795566753; Email: kevin.selby@unisante.ch
• Study Contact Backup: Name: Ekaterina Plys, PhD; Email: ekaterina.plys@unisante.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Center for Primary Care and Public Health (Unisante)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Provide participants with information about their personalized risk for colorectal cancer and appropriate screening recommendations to facilitate their screening option choice.
Active Comparator: Usual care group; 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; Provide participants with general information about options for colorectal cancer screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported overall screening participation	Proportion who completed any CRC screening test (FIT, colonoscopy, colonoscopy appointment, CT colonography, blood test, etc.	6-8 months after the intervention
Participation in the randomized trial	Proportion of those invited with completed paper or electronic consent	6 weeks after mailed invitations
Eligibility for the Vaud CRC screening program	Proportion of those who returned the baseline questionnaire who are eligible for the Vaud screening program (i.e. not up-to-date with screening, not in colonoscopy surveillance, no personal CRC history, etc.)	6 weeks after mailed invitations
Self-reported anxiety	Mean anxiety score using adapted questions from a standardized questionnaire (STAI Fr)	6 weeks after mailed invitations
Linkage to Vaud CRC screening program	Proportion of study participants who consent and whose screening status are obtained from the Vaud CRC screening program	3-6 months after measurement of primary outcome
Linkage to Vaud tumor registry	Proportion of study participants who consent and whose cancer status are obtained from the Vaud tumor registry. Long time frame chosen given considerable delay in updating the tumor registry and interest in cancer outcomes several years after measurement of primary outcome.	6 months to 10 years after measurement of primary outcome

Collaborators and Investigators

• Sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
• Investigators: Principal Investigator: Kevin Selby, MD, MAS, Center for Primary Care and Public Health (Unisante)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Study website
• Risk calculator used

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Shared Decision Making; Colorectal Cancer Screening; Risk Communication; Personalized Risk; Screening Behavior
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PRESENT STUDY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon publication of the primary results, the data that support the findings of this study will be available from the corresponding author upon reasonable request.
• IPD Sharing Time Frame: Will become available upon publication of the primary results and remain available 5 years.
• IPD Sharing Access Criteria: Reasonable request to the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No