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FIT for purpose: personalised surveillance colonoscopy for people at increased risk of colorectal cancer.

ABSTRACT: Interventions: Colorectal cancer (CRC) prevention programs are tailored to the degree of risk and within the Australian public health system with surveillance by colonoscopy usually reserved for those in the above average risk category. Different levels of risk, average, moderately increased and high, are recognised for population sub-groups. All potential participants will be taken from the ‘Southern Cooperative Program for the Prevention of Colorectal Cancer’ (SCOOP) which is a clinical database which consisting of individuals with a family history of CRC or a personal history of neoplasia, and who have their surveillance colonoscopies through two South Australian public hospitals and selected private hospitals. Commencing in 1999, this program currently has 7000 people enrolled and is made up of gastroenterologists, geneticists, nurses and support administrative staff and is coordinated from the Bowel health Service (BHS) at Flinders Centre for Innovation in Cancer (FCIC), Flinders Medical Centre. SCOOP also has a research arm to help improve the program and improve patient outcomes. It is estimated that there will be 4,500 eligible individuals from the SCOOP population, who will have a surveillance colonoscopy planned between the 2019 and 2023. Colonoscopy intervals are decided by the SCOOP team of specialists in conjunction with the National Health and Medical Research Council (NHMRC) ‘Clinical practice guidelines for surveillance colonoscopy’ 2018. As part of the program, SCOOP individuals are provided with a ‘Faecal Immunochemical Test’ (FIT) kit in the interval between their 3 or 5 yearly colonoscopies. Those with a 3 year colonoscopy interval will have an offer of FIT at 1 year and those with a 5 year colonoscopy interval will have an offer of FIT at 1 yea Primary outcome(s): To determine the safety of extending colonoscopy schedules by one-third, in intervention arm, by including interval Faecal Immunochemical Test (FIT) as evidenced by the decreased presence of advanced neoplasia as assessed by colonoscopy.[Group 1: Intervention arm - Assessed 6 months post colonoscopy.];Burden of having a colonoscopy as assessed by study-specific colonoscopy costing survey. [All participants in Group 1 only: Assessed 6 months post colonoscopy.] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Efficacy

DISEASE(S): Bowel Cancer Surveillance,Public Health-health Service Research,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2470177 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Colorectal cancer (CRC) prevention programs are tailored to the degree of risk and within the Australian public health system with surveillance by colonoscopy usually reserved for those in the above average risk category. Different levels of risk, average, moderately increased and high, are recognised for population sub-groups. People with known genetic syndromes (eg familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC, also known as Lynch Syndrome] are considered to be at high risk for CRC and are advised to undergo regular (every 1-2 years) colonoscopic surveillance. We propose to conduct this uncontrolled observational study, where patients self-select to the treatment group based on their participation in a colonoscopy surveillance program - the ‘Southern Cooperative Program for the prevention of colorectal cancer’ (SCOOP), run through Flinders Medical Centre and Noarlunga Hosptial. We will approach SCOOP patients and offer a FIT (Faecal Occult Blood Test) to be completed 1 - 2 weeks prior to their scheduled colonoscopy to determine the positive predictive value (PPV), negative predictive value (NPV), specificity and sensitivity for neoplasia of FIT, in comparison to colonoscopy. The FIT kit including an invitation letter, two collection tubes, instructions and a reply paid envelope, will be posted to study invitees. Participants will be required to self-collect two small stool samples (approximately 10mg of stool which is smaller than a grain of rice) with the provided collection devices. The samples will then be placed in the collection tubes, placed in a reply paid envelope and posted back to the testing laboratory. Following return to the testing laboratory, samples will be analysed for levels of faecal haemo Primary outcome(s): Faecal haemoglobin level as assessed by FIT test.[assessed within 1 - 2 weeks before the colonoscopy] Study Design: Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective

Project description:Interventions: We propose to conduct a prospective observational study to investigate how change in diet and lifestyle patterns over time impacts the development of precancerous colorectal lesions or colorectal cancer in individuals at above average risk of colorectal cancer and undergoing a colonoscopy surveillance - the ‘Southern Cooperative Program for the prevention of colorectal cancer’ (SCOOP). Data regarding patients’ colonoscopies will be extracted from the SCOOP database. Participants enrolled in the SCOOP program will be invited to complete the diet and lifestyle survey over the period of three years (in years 1 (baseline survey), 2 and 3 (follow-up surveys)). The survey can be completed by the participants either online, by clicking on a provided link or scanning a QR code. It is expected that each survey will require around 40-50 minutes to be filled out. The exposure variables include: -Dietary intake (using a validated food frequency questionnaire from the Australian Eating Survey), -Physical activity (using the International Physical Activity Questionnaire (IPAQ-L)), -Sleep patterns (Pittsburgh Sleep Quality Index (PSQI), Obstructive sleep apnoea screening questionnaire (OSAS), and Insomnia Severity Index questionnaire, -Smoking status, -Body mass index (BMI), -Aspirin intake, and -Comorbidities including diabetes. Primary outcome(s): The primary outcome of this study will be the dietary pattern that will be assessed using a validated food frequency questionnaire. [This will be assessed at baseline (year 1), years 2 and 3 at anytime during the three year observation period. Individuals whose colonoscopies are due within one year will receive only one diet survey (baseline), while those whose colonoscopies are due in two years’ time will receive only two diet surveys before their next scheduled colonoscopy. Most patients under surveillance will receive regular colonoscopies at intervals of 3 or 5 years, and they will be able to take part in all three diet surveys until the next scheduled colonoscopy.];Another primary outcome of this study will be sleep quality assessed by a validated International Physical Activity Questionnaire (IPAQ-L). [This will be assessed at baseline (year 1), years 2 and 3 at anytime during the three year observation period. Individuals whose colonoscopies are due within one year will receive only one physical activity survey (baseline), while those whose colonoscopies are due in two years’ time will receive only two physical activity surveys before their next scheduled colonoscopy. Most patients under surveillance will receive regular colonoscopies at intervals of 3 or 5 years, and they will be able to take part in all three physical activity surveys until the next scheduled colonoscopy.];Another primary outcome of this study will be sleep quality assessed by a validated Pittsburgh Sleep Quality Index (PSQI). [This will be assessed at baseline (year 1), years 2 and 3 at anytime during the three year observation period. Individuals whose colonoscopies are due within one year will receive only one sleep survey (baseline), while those whose colonoscopies are due in two years’ time will receive only two sleep surveys before their next scheduled colonoscopy. Most patients under surveillance will receive regular colonoscopies at intervals of 3 or 5 years, and they will be able to take part in all three sleep surveys until the next scheduled colonoscopy.] Study Design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective

Project description:Interventions: Over recent years there has been an increase in the development of new blood tests for the use in detection, monitoring and surveillance of cancers. It is important that acceptability to cancer surveillance with blood biomarkers is identified through a range of approaches. This research will use focus groups to identify acceptability of blood biomarker tests, as well as other methods such as CT scans and colonoscopy, for use in cancer surveillance. This will be done with: (1) people who have undergone treatment for the different cancers (oesophageal, stomach or bowel), (2) their carers or support persons, and (3) clinicians who are involved in cancer treatment. Individuals who have undergone treatment for oesophageal, stomach, or bowel cancer during the prior three years will be identified via the gastrointestinal cancer clinic lists at the Flinders Medical Centre for invitation into a focus group, along with their nominated support person. Clinicians will be invited into the focus groups through an information session or email. Prior to the focus group, consented individuals will be contacted by a member of the research team to collect baseline characteristics (e.g., demographics, details about cancer stage and treatment, roles covered as a support person or clinician). Focus groups will be held in person at Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, or via a web-based option such as Zoom or Microsoft TEAMS. The focus group will take approximately 45 minutes and each participant will only participate in one focus group. Separate focus groups will be held for patients, carers and clinicians, with approximately 6 people invited into each session. The focus groups will be led by facilitators (study researchers) who will follow a sem Primary outcome(s): Knowledge of clinical tests to monitor cancer treatment and surveillance, which will be assessed using qualitative, audio recorded, 45-minute focus group discussions which will be semi-structured based upon a study-specific discussion guide.[1 month after recruitment (during the focus group)];Trust in clinical tests to monitor cancer treatment and surveillance, which will be assessed using qualitative, audio recorded, 45-minute focus group discussions which will be semi-structured based upon a study-specific discussion guide.[1 month after recruitment (during the focus group)];Experience of clinical tests to monitor cancer treatment and surveillance, which will be assessed using qualitative, audio recorded, 45-minute focus group discussions which will be semi-structured based upon a study-specific discussion guide.[1 month after recruitment (during the focus group)] Study Design: Purpose: Psychosocial;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective

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FIT for purpose: personalised surveillance colonoscopy for people at increased risk of colorectal cancer.

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