Dataset Information

What test is best for you? A bowel cancer family history risk website for patients and their GP’s.

ABSTRACT: 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

DISEASE(S): Public Health-epidemiology,Bowel (colorectal) Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2456990 | 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: 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

What test is best for you? A bowel cancer family history risk website for patients and their GP’s.

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