None listed
Conditions
Brief summary
The SCRIPT Trial: A study of DNA testing to tailor bowel cancer screening in primary care. What is the purpose of this research? In Australia anyone aged 50-74 should have some sort of bowel cancer screening. People at increased rick of bowel cancer should start screening earlier. Screening is a highly effective way to diagnose bowel cancer earlier and save your life. There are two main ways you can be screened for bowel cancer, by FOBT (or poo test) or colonoscopy. Depending on your risk of getting bowel cancer, the age when you start and the type of bowel cancer screening will vary. Who is this for? People with a GP appointment at participating General Practices, aged 45 to 70 years who have not previously been diagnosed with bowel cancer. Study Details: Once agreed and consented to take part, the researcher will ask some health questions then provide a DNA test to inform of bowel cancer risk. The researcher will discuss this test with the participant beforehand and the DNA sample is by a self collected mouth swab. After this the participant is placed at random into one of two groups. Randomisation means that you are put into a group by chance, like the toss of a coin. Neither the participant or their doctors can chose which group. If in the intervention group, after 2-3 weeks the participant will meet with the researcher at the GP practice or by phone to discuss the DNA test results. They will be given a report summarising their bowel cancer risk and screening recommendations to be discussed with their GP. For the control group, they will have a consultation with the researcher to discuss cancer risk, lifestyle factors and bowel cancer screening options. They will be given the option to receive their bowel cancer risk results after 12 months from recruitment. Follow up questionnaires will be sent to all participants at 1, 6 and 12 months after recruitment.
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/pos
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 national guidelines Participants in the intervention arm will return 2-3 weeks after their pre-test consultation/recruitment to discuss the results of their polygenic risk score with the researcher. Due to the global pandemic and ongoing government restrictions, participants may complete this in person at their general practice or via video call. A print-out summarising the participant’s colorectal cancer risk and screening recommendations will be given to them to discuss with their GP who will, if required, organise appropriate colorectal cancer screening. The risk report is designed to increase response efficacy for screening (a person’s belief that the behaviour will reduce their disease risk). Those who are due for an FOBT kit will be given a test kit and a brief demonstration on its use to increase their self-efficacy to perform the test. Intervention participants will complete a baseline questionnaire at recruitment and another at 1, 6 and 12 months post recruitment either online or by hardcopy.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
•Eligible participants for the trial are aged between 45 and 70 years old •Participants able to read and write English and competent to give informed consent •Participants who are contactable over the next 12 months for the study follow-up Inclusion restricted to patients that are potentially due for some form of bowel cancer screening within the next 12 months, i.e.: o All patients aged 45-50 will be, included as we will not know their genomic risk pre-recruitment. Some will be at increased risk and therefore be recommended early screening in the study; o Those aged 50-70 years of age who report not having an FOBT in last 2 years.
Exclusion criteria
•Patients with a previous diagnosis of colorectal cancer are excluded •Patients with at least one grandparent was born in Africa or is of African ethnicity are ineligible to participate due to the specificity of the DNA test •Patients with a known genetic predistortion to colorectal cancer or a family history of cancer that requires referral for assessment of a genetic predisposition to colorectal cancer are excluded (according to the NHMRC guidelines). This includes: o Those confirmed as carrying a pathogenic mutation in a gene associated with a high-risk familial syndrome o Those with a relative confirmed as carrying a pathogenic mutation in a gene associated with a high-risk familial syndrome, who have not themselves been tested o Those with or those with a relative with familial adenomatous polyposis o Those with a relative with multiple colorectal cancers o Those with at least three first-degree or second-degree relatives with a Lynch syndrome-related cancer (colorectal, endometrial, ovarian, stomach, small bowel, renal pelvis or ureter, biliary tract, brain) with at least one diagnosed before age 55 years). Patients with recent rectal bleeding or inflammatory bowel disease are excluded and referred for assessment by their GP because they may require colonoscopy as a diagnostic rather than screening procedure.
Outcome results
None listed