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Personalised risk information and its impact on informed choice and intention to undergo colonoscopy in the Scottish Bowel Screening Programme

ABSTRACT: Background and study aims This early phase study aims to assess what patient responses would be if they were given personalised risk information about their chances of having colorectal (bowel) cancer. In Scotland the existing bowel screening test (the guaiac Faecal Occult Blood test) is being replaced by a new test, called the Faecal Immunochemical Test (FIT), which requires a single stool sample. This test is easier to do and also gives more accurate information about an individual’s risk of having colorectal cancer, based on their age and sex. The aim of this study is to test whether giving individuals personalised information on their risk of colorectal cancer, would help them to decide what is best for them, when weighed up alongside the risks of having further investigation via a colonoscopy (i.e. a test where a tiny camera is inserted into the bowel to check for anything which is out of the ordinary). It will also assess whether this would lead to more or fewer people deciding to have a colonoscopy and aims to find out the best way of presenting this information, so that people can fully understand it. Who can participate? Adults aged 50-74 registered on the Scottish Bowel Screening database. What does the study involve? Participants are randomised to one of three groups to receive information about their risk of cancer following a hypothetical result for detected faecal haemoglobin concentration (amount of blood in their stool sample), based on their age, gender and faecal haemoglobin concentration: 1) personalised risk information in numeric form (e.g. 1 in 100), 2) personalised information described as ‘high’, ‘medium’ or ‘low’ risk, and 3) as a ‘positive’ test result, as is currently given to people. The best methods to present this information is determined by this study, with the help of members of the public, two of who are part of the project team. Each participant is sent the information by letter and asked to say whether or not they would intend to take up the offer of a colonoscopy for each level of risk. The groups are compared on whether or not their decision was based on a sound understanding of the information (informed choice), whether or not they intend to have a colonoscopy, and how satisfied they are with their decision.

DISEASE(S): Colorectal Cancer Screening

PROVIDER: 2410632 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Colorectal cancer often arises from adenomatous polyps. Polyps can grow and progress to cancer, but may also remain static in size, regress, or resolve. Prediciting which progress to cancer and which remain benign is difficult. We developed a long-lived murine model of colorectal cancer with tumors that can be followed by colonoscopy. Our aim was to assess whether these tumors have similar growth patterns and histologic fates to human colorectal polyps to identify features to aid in risk stratification of colonic tumors. Long-lived Apcin/+ mice were treated with 4% dextran sodium sulfate to promote colonic tumorigenesis. Tumor growth patterns were characterized by serial colonoscopy, and pathology was determined. Serial biopsies of tumors were obtained for immunohistochemistry and gene expression profiling by microarray analysis with Affymetrix Whole Genome array. Tumors (n=424) grew, remained static, regressed, or resolved over time with different relative frequencies. Newly developed tumors demonstrated dynamic growth patterns with higher rates of growth and resolution, while more established tumors tended to remain static in size. Colonic tumors were hyperplastic lesions (3%), adenomas (73%), intramucosal carcinomas (20%), or adenocarcinomas (3%). Differentially expressed genes between adenomas and intramucosal carcinomas were identified. We did not identify differentially expressed genes between early and late biopsies from the same tumor. This novel murine model of intestinal tumorigenesis develops colonic tumors that can be monitored by serial colonoscopy, mirror growth patterns seen in human colorectal polyps, and progress to colorectal cancer. Further characterization of cellular and molecular features are needed to determine which features can be used to risk-stratify polyps for progress to colorectal cancer and potentially guide prevention strategies. F1 (SWR x C57BL/6) Apcin/+ mice who had been given two treatments of 4% dextran sodium sulfate in drinking water at weaning underwent colonoscopy around 80 days of age. Those with distal colonic tumors amenable to biopsy had two biopsies taken at that time. Tumors were monitored by colonoscopy every 14 days. Every 28 days, two additional biopsies were taken of each tumor. This protocol was repeated until mice were moribund. Six tumors were removed after sacrifice. The earliest and latest biopsies of each tumor were selected for RNA extraction and Affymetrix hybridization.

Project description:Interventions: Eligible people (n = 240) within the SCOOP program (a colonoscopy surveillance program for individuals at higher risk for bowel cancer) at Repatriation General Hospital or Flinders Medical Centre who do not screen for bowel cancer via the standard means (ie. faecal testing), will be sent a letter to invite them to screen for bowel cancer with a blood test (Colovantage Plasma), as well as a short survey to ascertain their demographic details and their screening history. Anyone interested in taking up the blood screening test will be asked to fill in the consent form and request form and send them back (in the provided reply paid envelope) to the Bowel Health Service. Following receipt of the blood test request form, the study enrolee will then be sent further information on the blood test (including information on the accuracy of the test, where they can get their blood collected, and when they will receive their test results) and a test referral. They can then take up the offer of the free screening blood test at one of four local blood collection centres (Healthscope). They do not need to be fasted and appointments do not need to be made. Reminder letters will be sent after 6 weeks to those people who have not taken up the blood test screening offer. Screening participation rate with the blood test and demographic factors that influence uptake, will be assessed at the 12 week time point. Primary outcome(s): The primary outcome is to determine how many people within 12 weeks following the invitation letter have a blood sample collected for bowel cancer screening (ie. outcome = blood test participation rate). The number that complete the blood test will be expressed as a percentage of the invited cohort (ie. 240)[12 weeks after invitation to screen.];An additional primary outcome will be to determine the factors that predict screening uptake with the blood test, ie. age, gender, risk status for bowel cancer, reasons for not participating with faecal testing. This information will be established via a short survey (designed specifically for this study) that is provided with the original study invitation letter.[12 weeks after invitation to screen.] Study Design: Purpose: Prevention; Allocation: Non-randomised trial

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Personalised risk information and its impact on informed choice and intention to undergo colonoscopy in the Scottish Bowel Screening Programme

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