Colorectal cancer screening based on predicted risk: a pilot randomized controlled trial

Abstract

Background & Aims: Colorectal cancer (CRC) screening relies primarily on colonoscopy and fecal immunochemical testing (FIT). Aligning utilization of these options with individual CRC risk (i.e. personalized screening) may maximize benefit with lower risks, individual burdens, and societal costs. We studied the effect of communicating personalized CRC risk and corresponding screening recommendations on appropriate screening uptake in an organized screening setting. Methods: Pilot randomized controlled trial among residents aged 50-69 years old not yet invited for screening in Vaud, Switzerland. The intervention was a mailed brochure communicating individual 15-year CRC risk and corresponding screening recommendation. The control group received a brochure comparing FIT and colonoscopy. The primary outcome was self-reported risk-appropriate screening (FIT if <3% risk, FIT or colonoscopy if ≥3% and <6%, colonoscopy if ≥6%), assessed by a mailed questionnaire at 6 months. A secondary outcome was overall screening uptake. Results: Of 5396 invitations, 1059 people responded (19%), of whom 258 were randomized to intervention and 257 to control materials (average 15-year risk 1.4% (SD 0.5), age 52.2 years (SD 2.2), 51% women). Risk-appropriate screening completion was 37% in the intervention group and 23% in the control group (absolute difference 14%, 95%CI 6%-22%, p<0.001). Overall screening uptake was 50% in the intervention and 49% in the control group (absolute difference 1%, 95CI -7%-10%, p=0.758). Conclusions: In a population not known to be at elevated CRC risk, brochures providing personalized CRC risk and screening recommendations improved risk-appropriate screening without impacting overall screening uptake. This approach could be helpful for aligning screening methods, risks, and benefits with cancer risk. Trial registration: Clinicaltrials.gov NCT05357508.

Competing Interest Statement

Marie-Anne Durand has contributed to the development of Option Grid patient decision aids. EBSCO Information Services sells subscription access to Option Grid patient decision aids. She receives consulting income from EBSCO Health, and royalties. No other competing interests declared from her or the other investigators.

Clinical Trial

NCT05357508

Clinical Protocols

https://www.researchprotocols.org/2023/1/e46865

Funding Statement

This study was financed by a grant from the Swiss Cancer Research Foundation (KLS 5111-08-2020). The salary of Kevin Selby is paid in part by the Fondation Leenaards.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The trial was monitored by an institutional monitoring team and received approval from the Ethics committee of the canton of Vaud on March 2, 2022 (project ID 2021-02431).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

The data generated and analyzed during this study are available from the corresponding author on reasonable request.

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