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Trial registered on ANZCTR
Registration number
ACTRN12620001003965
Ethics application status
Approved
Date submitted
10/08/2020
Date registered
6/10/2020
Date last updated
25/05/2022
Date data sharing statement initially provided
6/10/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Should I Take Aspirin? The SITA Trial, a randomised controlled trial of a decision aid to support informed choices about taking aspirin to prevent bowel cancer for Australians aged 50 to 70 years
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Scientific title
Should I Take Aspirin? The SITA Trial: an RCT of a decision aid to support informed choices about taking aspirin to prevent bowel cancer and other chronic diseases
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Secondary ID [1]
301994
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None
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Universal Trial Number (UTN)
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Trial acronym
SITA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer prevention
318557
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Cardiovascular disease prevention
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Condition category
Condition code
Cancer
316568
316568
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Cardiovascular
323741
323741
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study aims to test the efficacy of a decision aid, using an expected frequency tree which visually displays statistics and further provides numerical evidence and to present the benefits and harms of low dose aspirin, on informed decision making and uptake of aspirin in general practice.
a) Description of the decision aid: The male and female decision aids are brochures with an accompanying 3-minute video. The video is designed to be talked through with the participants in a consultation with a research assistant and it covers the exact information which is found in the hard copy brochure. The video and brochure formats of the decision aid is designed to communicate the benefits and risks of taking low-dose aspirin, 100 – 300 mg per day, as defined by the Cancer Council Australia, to the participants. Each participant will be given the hard copy of the decision aid to take with them after the consultation with the research assistant. The decision aid also prompts the participants to speak with their general practitioner following their consultation with the research assistant as taking aspirin may or may not be right for them.
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Intervention code [1]
318284
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Prevention
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Comparator / control treatment
The control group participants will be given a bowel cancer prevention information in a brochure which has been modified from the Cancer Council Victoria: ‘How to cut your cancer risk’ sheet and the Bowel Cancer Australia modifiable risk factors website and explain the contents of the brochure. The research assistant will talk through the contents of the control brochure.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome is self-reported daily adherence to aspirin as assessed by a 6 month follow up a questionnaire which has been designed specifically for this study.
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Assessment method [1]
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Timepoint [1]
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6 months after enrollment
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Primary outcome [2]
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The second primary outcome is participants ability to make an informed choice as measured by the validated scale called the Multi-dimensional Measure of Informed Choice asks about participants knowledge, attitudes and behaviour which is asked in the 1-month follow up questionnaire.
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Assessment method [2]
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Timepoint [2]
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1-month after enrollment
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Secondary outcome [1]
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How comfortable the participants are with numbers as measured by the Subjective Numeracy Scale
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Assessment method [1]
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Timepoint [1]
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At baseline, following consent, during the baseline questionnaire
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Secondary outcome [2]
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Conflict in deciding to take low-dose aspirin as measured by the Decisional Conflict Scale
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Assessment method [2]
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Timepoint [2]
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1-month after enrollment
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Secondary outcome [3]
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The proportion of participants who self-reported regular adherence to daily aspirin (i.e., taken five or more out of seven days a week) at one month was assessed in the follow-up questionnaire designed for this trial.
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Assessment method [3]
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Timepoint [3]
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1-month after enrollment
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Secondary outcome [4]
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The proportion of participants who made changes to their diet to reduce their chances of getting bowel cancer since they joined the study at one and six months was assessed in the follow-up questionnaire designed for this trial.
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Assessment method [4]
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Timepoint [4]
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One and six months after enrollment
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Secondary outcome [5]
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The proportion of participants who had a consultation with their general practitioner between baseline and six months was self-reported in the follow-up questionnaires designed for this trial
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Assessment method [5]
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Timepoint [5]
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Six months after enrolment.
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Secondary outcome [6]
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The proportion of participants who talked to their GP about quitting smoking to reduce their chances of getting bowel cancer since they joined the study at one and six months was assessed in the follow-up questionnaire designed for this trial.
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Assessment method [6]
410058
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Timepoint [6]
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One and six months after enrolment.
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Secondary outcome [7]
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The proportion of participants who quit smoking to reduce their chances of getting bowel cancer since they joined the study at one and six months was assessed in the follow-up questionnaire designed for this trial.
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Assessment method [7]
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Timepoint [7]
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One and six months after enrolment.
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Secondary outcome [8]
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The proportion of participants who discussed with their GP screening for CRC by faecal occult blood test (FOBT) or colonoscopy to reduce their chances of getting bowel cancer since they joined the study at one and six months was assessed in the follow-up questionnaire designed for this trial.
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Assessment method [8]
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Timepoint [8]
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One and six months after enrolment.
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Secondary outcome [9]
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The proportion of participants who completed screening for CRC by FOBT or colonoscopy to reduce their chances of getting bowel cancer since they joined the study at one and six months was assessed in the follow-up questionnaire designed for this trial.
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Assessment method [9]
410061
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Timepoint [9]
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One and six months after enrolment.
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Secondary outcome [10]
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The proportion of participants who talked to their GP about taking aspirin to reduce their chances of getting bowel cancer since they joined the study at one and six months was assessed in the follow-up questionnaire designed for this trial.
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Assessment method [10]
410062
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Timepoint [10]
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One and six months after enrolment.
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Eligibility
Key inclusion criteria
Eligible patients will be aged 50-70, able to read English and competent to give informed consent.
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Minimum age
50
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
People with contraindications to aspirin (e.g. previous peptic ulcer, taking anticoagulants) or those using aspirin regularly will be excluded.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All research staff including the researcher who will be conducting the follow-up and analysing the data will be blinded to the allocation of the participants. The only researchers who will be unblinded are the two research assistants delivering the intervention, but the baseline questionnaire will be administered prior to randomisation so all data collection from participants will be blinded. The participants themselves are told that the study is about bowel cancer prevention and that both groups would receive brochures about how to prevent bowel cancer but they aren't told that one receives information about aspirin for bowel cancer prevention specifically. So, the participants are blinded as to which group they are in as well.
The method for allocation concealment is done through the REDCap database using centralised stratified randomisation. The randomisation table was created and uploaded into REDCap by the trial statistician.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated equally (1:1) to the intervention or control group. The allocation sequence will be computer-generated stratified by general practice, using permuted blocks of random sizes. To ensure concealment, the block sizes will not be disclosed. The allocation schedule will be generated by the trial statistician will not be involved in the recruitment of participants or data collection. The allocation schedule will be embedded within the online database, REDCap, which will automatically assign the participant after they complete the baseline survey to either intervention or control group ensuring allocation concealment.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
All randomised patients will be eligible for inclusion in the analysis in accordance with the
intention-to-treat principle. Appropriate methods for dealing with missing endpoint data will be detailed in the statistical analysis plan. Baseline characteristics of the two arms will be summarised using descriptive statistics. The primary analysis will be a comparison between groups on the proportion of participants who are taking regular aspirin at 6 months, using logistic regression with the randomisation stratification factor, general practice, as a covariate. Reasons for ineligibility, refusal to consent and attrition will be recorded, and recruitment and dropout bias assessed.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/11/2020
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Actual
12/10/2020
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Date of last participant enrolment
Anticipated
2/08/2021
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Actual
22/04/2021
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Date of last data collection
Anticipated
18/02/2022
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Actual
23/11/2021
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Sample size
Target
258
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Accrual to date
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Final
264
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
37648
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3142 - Toorak
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Recruitment postcode(s) [2]
37649
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3011 - Footscray
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Recruitment postcode(s) [3]
37650
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3444 - Kyneton
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Recruitment postcode(s) [4]
37651
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3450 - Castlemaine
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Recruitment postcode(s) [5]
37652
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3123 - Hawthorn East
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Recruitment postcode(s) [6]
37653
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3043 - Gladstone Park
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Victorian Cancer Agency
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Address [1]
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50 Lonsdale Street, Melbourne, Victoria 3004
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Melbourne
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Address
Parkville VIC 3010
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
306929
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Address [1]
306929
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Country [1]
306929
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Medicine and Dentistry Human Ethics Sub-Committee
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Ethics committee address [1]
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Alan Gilbert Building Level 5, The University of Melbourne 161 Barry Street, Victoria, 3010
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Ethics committee country [1]
306613
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Australia
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Date submitted for ethics approval [1]
306613
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10/06/2020
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Approval date [1]
306613
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28/07/2020
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Ethics approval number [1]
306613
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2056513
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Summary
Brief summary
Cancer Council Australia recently published evidence-based guidelines which recommend that people aged 50-70 years consider taking aspirin to prevent bowel cancer. The purpose of this study is to determine if a new decision aid is effective in teaching the public about the benefits and risks of taking low dose aspirin and whether there is a change in the use of aspirin. Who is it for? You may be eligible for this study if you are an adult between 50-70 years of age and live in Victoria. Study details Participants in this study will be randomly selected to take part in one of two interventions: 1. The decision aid brochure group, where participants will receive a brochure which explains the benefits and risks of taking low-dose aspirin and 2. The reduce your bowel cancer risk brochure group, where participants will receive a brochure on how to cut your cancer risk and directed to the Cancer Council Victoria and Bowel Cancer Australia modifiable risk factors websites. Participants will then be followed up after 1 and 6 months, at which point they will need to complete a questionnaire on their thoughts, how they feel about numbers and use their of aspirin. It is hoped that this research will help determine if this decisional aid is effective in educating participants in the harms and benefits of the use of low dose aspirin.
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Trial website
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Trial related presentations / publications
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Public notes
Conference Presentation: Implementing the aspirin guidelines into clinical care (I-MAGIC Project) Shakira R Milton, Jennifer McIntosh, Pavrithan Alphonse, Thivagar Yogaparan, Sibel Saya, Napin Karnchanachari, Phyllis Lau, Finlay Macrae, Jon Emery Publication date 2019/11/1 Conference ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY Volume 15 Pages 142-143 Publisher WILEY
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Contacts
Principal investigator
Name
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Prof Jon Emery
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Address
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Victorian Comprehensive Cancer Centre
Level 10, 305 Grattan Street, Melbourne, VIC 3000
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Country
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Australia
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Phone
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+61 417 123 271
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Shakira MIlton
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Address
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Victorian Comprehensive Cancer Centre
Level 10, 305 Grattan Street, Melbourne, VIC 3000
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Country
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Australia
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Phone
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+61 420506330
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Shakira MIlton
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Address
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Victorian Comprehensive Cancer Centre
Level 10, 305 Grattan Street, Melbourne, VIC 3000
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Country
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Australia
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Phone
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+61 420506330
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Undecided IPD
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
16200
Study protocol
Milton, S., McIntosh, J., Macrae, F. et al. An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: a study protocol for the SITA (Should I Take Aspirin?) trial. Trials 22, 452 (2021). https://doi.org/10.1186/s13063-021-05365-8
https://doi.org/10.1186/s13063-021-05365-8
[email protected]
16201
Statistical analysis plan
[email protected]
16202
Statistical analysis plan
[email protected]
380352-(Uploaded-23-05-2022-14-31-54)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: a study protocol for the SITA (Should I Take Aspirin?) trial.
2021
https://dx.doi.org/10.1186/s13063-021-05365-8
N.B. These documents automatically identified may not have been verified by the study sponsor.
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