None listed
Conditions
Brief summary
This study aims to evaluate the effect on risk-appropriate cancer screening of multi-cancer polygenic risk scores and tailored advice on risk-appropriate cancer screening in general practice. Who is it for? People aged 40-59 years old who are able to read and write in English and currently do not have any alarm symptoms or diagnosis of cancer. All participants must be under the care of a General Practitioner who is participating in the trial. Study Details Participants will be randomly allocated into the intervention or control group. The intervention group will receive an individualised cancer risk report and tailored advice for risk-appropriate screening for melanoma, colorectal, and breast or prostate cancer during a consultation with a researcher . The control group will receive the ‘Cut your Cancer Risk’ brochure and information about lifestyle factors that can impact cancer risk during a consultation with a researcher. This study will contribute to what we know about how individualised risk information can impact peoples' cancer screening behaviours.
Interventions
The intervention is a ‘complex intervention’ and contains several components. The main component is a polygenic risk score, with a post-test consultation (approximately 30 minutes in duration) to discuss the participant's personal risk of melanoma, colorectal, breast and prostate cancer with an associated risk report for the participant and their GP.
Participants will attend an appointment (approximately 30 minutes) with a trained researcher to complete consent, collect demographic details an
The intervention is a ‘complex intervention’ and contains several components. The main component is a polygenic risk score, with a post-test consultation (approximately 30 minutes in duration) to discuss the participant's personal risk of melanoma, colorectal, breast and prostate cancer with an associated risk report for the participant and their GP. Participants will attend an appointment (approximately 30 minutes) with a trained researcher to complete consent, collect demographic details and complete a baseline questionnaire regarding family history of cancer and cancer screening activities. Participants in the intervention group will provide a DNA sample using a saliva kit. They will receive the results of the polygenic risk score during a consultation with a research 3-4 weeks later. A polygenic risk score for each cancer will be generated from the presence or absence of each of the SNPs (consisting of those known to be associated with risk of the relevant cancer), using the most up-to-date relative risks of cancer for each DNA variant and the individual’s family history of cancer. Applying Australian age-sex incidence data, a 10-year absolute risk of each cancer will be calculated. Screening recommendations will be generated to correspond to NHMRC-endorsed national guidelines for each cancer. No participant will be recommended less screening than the current NHMRC-endorsed national guidelines. The reports are designed to alter screening and referral behaviours, with details for how participants can action their recommendations (e.g. contact details for BreastScreen Victoria to book a mammogram). Approximately 10% of these consultations will be audio recorded (involving participants who confirmed their consent to being audio recorded in their trial consent form) for quality control purposes. A print-out report summarising the participant’s cancer risks and screening recommendations will be given to the participant and their GP to discuss. The GP will, as required, organise appropriate 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.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
•Are aged between 40 and 59 years •Are able to read and write English and competent to give informed consent •Are contactable over the next 12 months for trial follow-up
Exclusion criteria
•Have been diagnosed with any of breast, prostate, colorectal cancer or melanoma; •Have any alarm symptoms that are potentially indicative of any cancer: Once or more and not investigated: Blood in stool or urine •For more than four weeks and not investigated: Problems with urination Diarrhoea Unexplained weight loss An unusual pain, lump or swelling anywhere in the body A new or changed spot on the skin; •Have a known genetic predisposition to any of the four cancers in question or, a first-/second-degree relative with a genetic predisposition and the participants has not had genetic testing themselves. This includes (but is not limited to) by a pathogenic variant in any of the following genes: CRC: Lynch syndrome (MLH1, PMS2, MSH2, MSH6, EPCAM), familial adenomatous polyposis (APC); BrCa: BRCA1, BRCA2, PALB2, ATM, CHEK2; PrCa: BRCA1, BRCA2, HOXB13; Melanoma: CDKN2A/p16. •Have any health condition or illness that, in the opinion of the participant or researcher, would impact their appropriateness for cancer screening or their ability to participate
Outcome results
None listed