Dataset Information

Colorectal Cancer Screening Based on Predicted Risk

ABSTRACT: 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.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2726491 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: This study is testing the behavioural impact of a ‘complex intervention’ which comprises several parts. The main part is a genomic test - (i.e., a personalised risk estimate determined from the participant’s polygenic risk score - which will be collected via a single saliva collection kit; participants self-reported family history of cancer, age and sex) with personalised screening recommendations derived from this risk. The initial consult whereby the genomic risk will be determined will be followed up 2-3 weeks later, whereby participants will be invited to attend a 20-minute one-on-one visit with a researcher to go through their personal risk report, participants will receive their personal risk score report and be given recommendations for screening for each cancer type. These reports have been developed specifically to inform about risk but also to impact cancer screening behaviour. The risk reports will include clear and succinct written detail about cancer screening recommendations for the four cancers as well as infographics depicting the participants specific risk scores and diagrams that depict the differences in mortality for populations that do and don’t screen for the four cancers. All these diagrams and infographics will be discussed during the results meeting with the researcher. Reports will be given to both participants and GPs by the researcher conducting the results appointments, these will be given to participants and GPs either by hardcopy or provided electronically via email or secure password protected hyperlink The follow-up consultation between participant and researcher will be conducted in person or via telehealth method - whichever is preferrable to the participant, where a discussion around personal risk and screening pa Primary outcome(s): To measure the effect on screening behaviour of a personalised cancer risk estimate for breast cancer (derived from a polygenic risk score) for primary care patients aged 45-59. The primary outcome is the proportion, for breast cancer, who complete risk-appropriate screening of those who require screening within six months follow up post the genomic risk results. Screening behaviour will be determined from participant self-report (from the study-specific follow-up questionnaires) and GP record audit. Risk-appropriate screening is defined as being concordant with the screening recommended as part of the intervention. How the risk-appropriate screening recommendations will be derived from the Australian National Screening Guidelines. Screening behaviour will be obtained from the following sources: 1. Participant self-report; 2. Data from their GP records (results of screening tests for breast cancer e.g. mammogram, breast ultrasound etc.); Processes to obtain consent to access these data will already be established.[Baseline (participant recruitment/DNA test) and 6 months (post-recruitment). 1 month, 2 month and 6 month post recruitment questionnaires. ];To measure the effect on screening behaviour of a personalised cancer risk estimate for bowel cancer (derived from a polygenic risk score) for primary care patients aged 45-59. The primary outcome is the proportion, for bowel cancer, who complete risk-appropriate screening of those who require screening within six months follow up post the genomic risk results. Screening behaviour will be determined from participant self-report (from the study-specific follow-up questionnaires) and GP record audit. Risk-appropriate screening is defined as being concordant with the screening recommended as part of the intervention. How the risk-appropriate screening recommendations will be derived from the Australian National Screening Guidelines. Screening behaviour will be obtained from the following sources: 1. Participant self-report; 2. Data from their GP records (results of screening tests for bowel cancer e.g. iFOBT, colonoscopy etc.); Processes to obtain consent to access these data will already be established.[Baseline (participant recruitment/DNA test) and 6 months (post-recruitment). 1 month, 2 month and 6 month post recruitment questionnaires.];To measure the effect on screening behaviour of a personalised cancer risk estimate for prostate cancer (derived from a polygenic risk score) for primary care patients aged 45-59. The primary outcome is the proportion, for prostate cancer, who complete risk-appropriate screening of those who require screening within six months follow up post the genomic risk results. Screening behaviour will be determined from participant self-report (from the study-specific follow-up questionnaires) and GP record audit. Risk-appropriate screening is defined as being concordant with the screening recommended as part of the intervention. How the risk-appropriate screening recommendations will be derived from the Australian National Screening Guidelines. Screening behaviour will be obtained from the following sources: 1. Participant self-report; 2. Data from their GP records (results of screening tests for prostate cancer e.g. PSA test, prostate biopsy, discussion about consideration of PSA testing etc.); Processes to obtain consent to access these data will already be established.[Baseline (participant recruitment/DNA test) and 6 months (post-recruitment). 1 month, 2 month and 6 month post recruitment questionnaires.] Study Design: Purpose: Prevention; Allocation: Non-randomised trial

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Colorectal Cancer Screening Based on Predicted Risk

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