The CRISP (Colorectal cancer RISk Prediction tool) trial: providing personalised advice about bowel cancer screening in primary care..
Ontology highlight
ABSTRACT:
DISEASE(S): Cancer-bowel-small Bowel (duodenum And Ileum),Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)
PROVIDER: 2461847 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
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
| 2464615 | ecrin-mdr-crc
Project description: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
| 2456990 | ecrin-mdr-crc
Project description:PURPOSE: The IRSN-23 model uses DNA microarray analysis of tumor tissue to personalize patients into highly sensitive chemotherapy (Gp-R) or less sensitive (Gp-NR) based on the expression of immune-related genes. This study assessed the reproducibility of the IRSN-23 in prospective independent validation sets and investigated its clinical significance and impact on breast cancer subtype classification. METHODS: Tumour tissues were collected from 146 breast cancer patients undergoing preoperative chemotherapy (paclitaxel-FEC) ± trastuzumab in Osaka University Hospital (OUH). Patients were classified into Gp-R or Gp-NR using IRSN-23, and the model was examined for its ability to predict the pathological complete response (pCR). RESULTS: In the OUH prospective dataset, the pCR rate was significantly higher in the Gp-R group (29·3% (11/41)) than in the Gp-NR group (1·4% (1/71)) not using trastuzumab (P = 1·70E-5). CONCLUSION: This study provides prospective validation of the IRSN-23 in predicting chemotherapy efficacy, demonstrating a high degree of reproducibility.
2023-05-19 | GSE230881 | GEO
Project description:Despite a pathological complete response, risk-of-relapse remains a challenge for most of epithelial ovarian cancer (EOC) patients and an ad-hoc predictor can be a valuable clinical tool. We developed a 35 miRNAs-based predictor of Risk of Ovarian Cancer Relapse (MiROvaR) using a training set of patients from MITO-2 (Multicentre Italian Trials in Ovarian Cancer-2; Pignata S et al. J Clin Oncol. 2011 Sep 20). MiROvaR performance was confirmed in two independent validation cohorts.
2016-10-31 | GSE73582 | GEO
Project description:Despite a pathological complete response, risk-of-relapse remains a challenge for most of epithelial ovarian cancer (EOC) patients and an ad-hoc predictor can be a valuable clinical tool. We developed a 35 miRNAs-based predictor of Risk of Ovarian Cancer Relapse (MiROvaR) using a training set of patients from MITO-2 (Multicentre Italian Trials in Ovarian Cancer-2; Pignata S et al. J Clin Oncol. 2011 Sep 20). MiROvaR performance was confirmed in two independent validation cohorts.
2016-10-31 | GSE73581 | GEO
Project description:Background and study aims
Previous research has shown that providing cancer risk information to people can improve their understanding of their risk of cancer, increase their intention to attend cancer screening, and increase their fruit and vegetable intake and physical activity. A risk calculator has been developed and tested based on modifiable behavioural risk factors, such as weight and smoking, which estimates the risk of an individual developing one of the five most common preventable cancers in the UK over a 10-year period. These cancers are lung, bowel, bladder, kidney and oesophageal cancer for men and breast, lung, bowel, endometrial and kidney cancer for women). Alongside 66 healthcare professionals who have taken part in focus groups and interviews, a web-based tool has been developed which allows people to enter details of their current lifestyle and then see their estimated risk of developing one of the cancers over the next 10 years, the effect changes in their lifestyle would make on that risk, and lifestyle advice. The aim of this study is to use that web-based tool to test whether people given their personalised cancer risk estimate in combination with lifestyle advice are more motivated to make changes in their behaviour than people given lifestyle advice alone. The study also compares different ways of presenting the risk information.
Who can participate?
Men and women aged 30-74 who do not have a past history of cancer
What does the study involve?
Participants answer a set of questions about their diet, lifestyle and beliefs about their risk of cancer. They are then randomly allocated to be presented with their personalised 10-year cancer risk and lifestyle advice, or go straight to the lifestyle advice without seeing their personalised risk. The cancer risk is presented in one of three formats. The first format is a bar chart, the second format is pictures of either 1000 or 100 faces depending on the individual's estimated risk, and the third format is a bar with a scale from below average to above average with arrows. Participants then answer a further set of questions about their thoughts about their risk of cancer and motivation to make lifestyle change. They are then asked if they agree to take part in a follow-up task 3 months later where they answer a similar set of questions to check how their lifestyle and ideas about cancer risk have changed with time. After completing that task, if they are one of the people who did not see their personalised risk in the first task, they are offered the opportunity to see it then.
| 2412635 | ecrin-mdr-crc
Project description:Interventions: Patients at Footscray Hospital will receive a personalised care plan summary which has the following components including Cancer stage, Planned treatment, Planned follow-up visits and Cancer helpline resources. The care plan summary will be generated and provided to the patient during their second consultation with the oncology clinician.
The consultation with the clinician will usually take approximately 30 minutes where they are provided the care plan and informed that they will be asked to complete a survey about how useful the care plan is in 6 months. The patient will be approached to complete the survey at a further consultation with the clinician.
The care plan summary will be generated from a HREC approved colorectal registry which all colorectal cancer patients at Footscray Hospital are entered into.
This study utilised a waiver of consent approach where the participants will be told about the study and a questionnaire which will be provided to them for completion after they have completed their first course of the treatment. No written consent will be obtained from the participants.
The duration of the study is approximately 7 months.
The plan is to roll this out to other centres and for other tumour streams if determined to be an effective communication tool.
Primary outcome(s): The successful development of electronically generated care plan for Colorectal Cancer (CRC) patients. This outcome will be assessed by running a report from the database on how many patients receive the care plan from the oncologist. We can measure this by comparing with the total number of patients entered onto the database.[Patients will receive their personalised care plan at their second clinic visit];Patient feedback and level of satisfaction with the information provided on their care plan and at their initial oncology clinic visits. This will be assessed through a patient survey that patients will be asked to complete.
The name of the survey developed for this study is Bowel Cancer Patient Information Survey’[At completion of patient’s treatment];To evaluate and analyse General Practitioner (GP) satisfaction of the care plan through an evaluation survey. The care plan will be uploaded to the hospital system and sent out electronically to GPs,
The name of the survey developed for this study is ‘GP Care Plan Evaluation Survey’[The evaluation of GPs will take place as soon as possible after the GP has received the care plan.]
Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective
| 2470149 | ecrin-mdr-crc
Project description:Subjects underwent endothelial testing and blood sampling at baseline and after 3 months of exercise training. Microarray and flow cytometry-based characterization of cells from an endothelial progeniator colony assay was consistent with T lymphocytes, but not endothelial cells. Experiment Overall Design: blood samples from 12 healthy subjects at baseline (A) and after 3 months (B) of exercise.
2009-01-13 | E-GEOD-12155 | biostudies-arrayexpress
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.
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Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel
| 2471685 | ecrin-mdr-crc
Project description:Interventions: This study is testing the behavioural impact of a ‘complex intervention’ which comprises several parts. The main part is a genomic test - (i.e., a personalised risk estimate determined from the participant’s polygenic risk score - which will be collected via a single saliva collection kit; participants self-reported family history of cancer, age and sex) with personalised screening recommendations derived from this risk. The initial consult whereby the genomic risk will be determined will be followed up 2-3 weeks later, whereby participants will be invited to attend a 20-minute one-on-one visit with a researcher to go through their personal risk report, participants will receive their personal risk score report and be given recommendations for screening for each cancer type.
These reports have been developed specifically to inform about risk but also to impact cancer screening behaviour. The risk reports will include clear and succinct written detail about cancer screening recommendations for the four cancers as well as infographics depicting the participants specific risk scores and diagrams that depict the differences in mortality for populations that do and don’t screen for the four cancers. All these diagrams and infographics will be discussed during the results meeting with the researcher.
Reports will be given to both participants and GPs by the researcher conducting the results appointments, these will be given to participants and GPs either by hardcopy or provided electronically via email or secure password protected hyperlink
The follow-up consultation between participant and researcher will be conducted in person or via telehealth method - whichever is preferrable to the participant, where a discussion around personal risk and screening pa
Primary outcome(s): To measure the effect on screening behaviour of a personalised cancer risk estimate for breast cancer (derived from a polygenic risk score) for primary care patients aged 45-59. The primary outcome is the proportion, for breast cancer, who complete risk-appropriate screening of those who require screening within six months follow up post the genomic risk results.
Screening behaviour will be determined from participant self-report (from the study-specific follow-up questionnaires) and GP record audit. Risk-appropriate screening is defined as being concordant with the screening recommended as part of the intervention. How the risk-appropriate screening recommendations will be derived from the Australian National Screening Guidelines.
Screening behaviour will be obtained from the following sources:
1. Participant self-report;
2. Data from their GP records (results of screening tests for breast cancer e.g. mammogram, breast ultrasound etc.); Processes to obtain consent to access these data will already be established.[Baseline (participant recruitment/DNA test) and 6 months (post-recruitment).
1 month, 2 month and 6 month post recruitment questionnaires.
];To measure the effect on screening behaviour of a personalised cancer risk estimate for bowel cancer (derived from a polygenic risk score) for primary care patients aged 45-59. The primary outcome is the proportion, for bowel cancer, who complete risk-appropriate screening of those who require screening within six months follow up post the genomic risk results.
Screening behaviour will be determined from participant self-report (from the study-specific follow-up questionnaires) and GP record audit. Risk-appropriate screening is defined as being concordant with the screening recommended as part of the intervention. How the risk-appropriate screening recommendations will be derived from the Australian National Screening Guidelines.
Screening behaviour will be obtained from the following sources:
1. Participant self-report;
2. Data from their GP records (results of screening tests for bowel cancer e.g. iFOBT, colonoscopy etc.); Processes to obtain consent to access these data will already be established.[Baseline (participant recruitment/DNA test) and 6 months (post-recruitment).
1 month, 2 month and 6 month post recruitment questionnaires.];To measure the effect on screening behaviour of a personalised cancer risk estimate for prostate cancer (derived from a polygenic risk score) for primary care patients aged 45-59. The primary outcome is the proportion, for prostate cancer, who complete risk-appropriate screening of those who require screening within six months follow up post the genomic risk results.
Screening behaviour will be determined from participant self-report (from the study-specific follow-up questionnaires) and GP record audit. Risk-appropriate screening is defined as being concordant with the screening recommended as part of the intervention. How the risk-appropriate screening recommendations will be derived from the Australian National Screening Guidelines.
Screening behaviour will be obtained from the following sources:
1. Participant self-report;
2. Data from their GP records (results of screening tests for prostate cancer e.g. PSA test, prostate biopsy, discussion about consideration of PSA testing etc.); Processes to obtain consent to access these data will already be established.[Baseline (participant recruitment/DNA test) and 6 months (post-recruitment).
1 month, 2 month and 6 month post recruitment questionnaires.]
Study Design: Purpose: Prevention; Allocation: Non-randomised trial
| 23145 | ecrin-mdr-crc