Dataset Information

The MAGPIE Study: Multi-cancer genomic risk assessment to target screening in general practice

ABSTRACT: 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

DISEASE(S): Bowel Cancer,Breast Cancer Screening,Melanoma,Bowel Cancer Screening,Cancer-malignant Melanoma,Cancer-prostate,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Prostate Cancer,Prostate Cancer Screening,Skin Cancer Screening,Breast Cancer,Cancer-breast

PROVIDER: 23145 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: The intervention is a web based Colorectal cancer RISk Prediction tool (CRISP) risk assessment tool utilising a risk model to provide patients with a personalised risk assessment and colorectal cancer screening advice based on their risk. Patients in the intervention group will be invited to complete the risk tool with a trained researcher prior to a consultation with their GP. The tool will take a maximum of 7 minutes and will be completed at baseline only. Participants will receive their risk of colorectal cancer and screening advice based on their risk which they will take with them into their consultation with their GP. All participants will also complete a survey collecting information about cancer risk perception, worry and bowel cancer screening intention and behaviour at baseline, 1 month, 6 months and 12 months after recruitment. The follow up survey should take no more than 15 minutes to complete and will be sent through the post or a link to the online survey will be sent via email. We will ask for permission to access GP records, records from Medicare, Victorian Admissions and Emergency Dataset (VAED) and from the National Bowel Screening Program (NBCSP) 1, 3 and 5 years after the participants enrol to track the colorectal cancer screening they have had. Primary outcome(s): The primary outcome will be the proportion of participants who have had risk-appropriate screening after 12 months’ follow-up. Appropriateness of screening will be determined by their absolute 5-year risk of CRC, using a 1% threshold and completion of FOBT, colonoscopy no screening, or a referral to a Familial Cancer Centre for genetic counselling if indicated by their family history. Patient self-report at 12 months will tell us what screening each patient has had and this will be cross-checked with GP records, records from Medicare, Victorian Admissions and Emergency Dataset (VAED) and from the National Bowel Screening Program (NBCSP)[12 months post recruitment] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Interventions: Individuals from intervention General Practices who opt in to the study will be given a password, allowing them to access the ‘Family History Website’ tool. This online tool will collect information about their family history of colorectal cancer and encourage discussion with their relatives so that they can gather accurate information. Upon completion of the questionnaire, individuals will be assigned to a NHMRC designated risk category for developing CRC, which will be accompanied by the appropriate screening recommendations, with a personalised summary of their information. This information will be accessible to their GP via a shared access facility, and participants will be encouraged to discuss their results with their GP within the following consultation. The completion of the family history website and GP consultation thereafter, is known as Assessment 1 at time = 0. Participants will be followed up 12 months after their completion of the ‘Family History Website’, where they will be required to self report their five year screening behaviour; while their GP’s will complete a file audit and a survey about the utility of the ‘Family History Website’ tool in addition to their knowledge about CRC risk and screening guidelines. This will be known as assessment 2 at time =1 Primary outcome(s): Outcome Aim: Risk appropriate screening uptake as measured by the participants’ five year screening behaviour in relation to their colorectal cancer risk category Five year screening behaviour- All participants will have their five year screening behaviour recorded at time=1 by self report[12 to 18 months after randomisation, t=1];Colorectal cancer risk category- Intervention practice participants will receive a CRC risk category after completing the ‘Family History Website’ tool., at some time within the 12 month time period t=0. However, participants from control practices will asked about their ‘known family history’ at time=1, and will not be allowed access to the ‘Family History Website’ tool, until after that information is collected.[Within 12 months of the intervention , t=0 for the intervention group and one year after randomisation, t=1 for the control group] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Interventions: The SCRIPT intervention is a ‘complex intervention’, that is, it contains several components. The main component is a polygenic risk score, with a post-test consultation (delivered face-to-face or via video call) to discuss the participant s personal risk with an associated risk reports for the participant and their GP. The reports are designed to alter screening and referral behaviours. Participants (recruited from general practice) will attend a consultation (face-to-face or via telephone/post), delivered by a trained researcher, during which their family history of colorectal cancer will be obtained, and brief pre-test counselling about the colorectal cancer polygenic risk score. This will include information about the test and its potential implications, including recommendations about colorectal cancer screening. A DNA sample will be obtained using the cheek swab at the first consultation. A polygenic risk score will be generated from the presence or absence of each of the 45 SNPs, using the relative risk of colorectal cancer for each DNA variant and also the individual’s family history of colorectal cancer. Applying Australian age-sex incidence data, a 10-year absolute risk of colorectal cancer will be calculated. Screening recommendations (faecal occult blood test (FOBT) or colonoscopy) will be generated in accordance with the 2017 NHMRC-endorsed national guidelines which are based on 10-year absolute risks of colorectal cancer. For those with a 10-year risk <1%, the would not require screening; for those with a 10-year risk >1% & <4%, they will be recommended FOBT screening; for those with a 10-year risk >4%, they will be recommended colonoscopic screening; however, no participant will be recommended less screening than the current NHMRC-endorsed n Primary outcome(s): To measure the effect of offering a polygenic risk score for colorectal cancer risk and tailored advice (i.e. the SCRIPT intervention) on risk-appropriate colorectal cancer screening (i.e. the right screening test, FOBT or colonoscopy, based on a person’s 10-year absolute risk of colorectal cancer) compared with generic cancer prevention information.[ 12 months post-recruitment. ] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel

Dataset Information

The MAGPIE Study: Multi-cancer genomic risk assessment to target screening in general practice

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