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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
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
Secondary ID [1] 301994 0
None
Universal Trial Number (UTN)
Trial acronym
SITA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer prevention 318557 0
Cardiovascular disease prevention 326468 0
Condition category
Condition code
Cancer 316568 316568 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cardiovascular 323741 323741 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 318284 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 324699 0
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.
Timepoint [1] 324699 0
6 months after enrollment
Primary outcome [2] 325046 0
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.
Timepoint [2] 325046 0
1-month after enrollment
Secondary outcome [1] 385427 0
How comfortable the participants are with numbers as measured by the Subjective Numeracy Scale
Timepoint [1] 385427 0
At baseline, following consent, during the baseline questionnaire
Secondary outcome [2] 386668 0
Conflict in deciding to take low-dose aspirin as measured by the Decisional Conflict Scale
Timepoint [2] 386668 0
1-month after enrollment
Secondary outcome [3] 410055 0
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.
Timepoint [3] 410055 0
1-month after enrollment
Secondary outcome [4] 410056 0
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.
Timepoint [4] 410056 0
One and six months after enrollment
Secondary outcome [5] 410057 0
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
Timepoint [5] 410057 0
Six months after enrolment.
Secondary outcome [6] 410058 0
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.
Timepoint [6] 410058 0
One and six months after enrolment.
Secondary outcome [7] 410059 0
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.
Timepoint [7] 410059 0
One and six months after enrolment.
Secondary outcome [8] 410060 0
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.
Timepoint [8] 410060 0
One and six months after enrolment.
Secondary outcome [9] 410061 0
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.
Timepoint [9] 410061 0
One and six months after enrolment.
Secondary outcome [10] 410062 0
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.
Timepoint [10] 410062 0
One and six months after enrolment.

Eligibility
Key inclusion criteria
Eligible patients will be aged 50-70, able to read English and competent to give informed consent.
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with contraindications to aspirin (e.g. previous peptic ulcer, taking anticoagulants) or those using aspirin regularly will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/11/2020
Actual
12/10/2020
Date of last participant enrolment
Anticipated
2/08/2021
Actual
22/04/2021
Date of last data collection
Anticipated
18/02/2022
Actual
23/11/2021
Sample size
Target
258
Accrual to date
Final
264
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 37648 0
3142 - Toorak
Recruitment postcode(s) [2] 37649 0
3011 - Footscray
Recruitment postcode(s) [3] 37650 0
3444 - Kyneton
Recruitment postcode(s) [4] 37651 0
3450 - Castlemaine
Recruitment postcode(s) [5] 37652 0
3123 - Hawthorn East
Recruitment postcode(s) [6] 37653 0
3043 - Gladstone Park

Funding & Sponsors
Funding source category [1] 306416 0
Government body
Name [1] 306416 0
Victorian Cancer Agency
Country [1] 306416 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 306929 0
None
Name [1] 306929 0
Address [1] 306929 0
Country [1] 306929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306613 0
Medicine and Dentistry Human Ethics Sub-Committee
Ethics committee address [1] 306613 0
Ethics committee country [1] 306613 0
Australia
Date submitted for ethics approval [1] 306613 0
10/06/2020
Approval date [1] 306613 0
28/07/2020
Ethics approval number [1] 306613 0
2056513

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104466 0
Prof Jon Emery
Address 104466 0
Victorian Comprehensive Cancer Centre
Level 10, 305 Grattan Street, Melbourne, VIC 3000
Country 104466 0
Australia
Phone 104466 0
+61 417 123 271
Fax 104466 0
Email 104466 0
jon.emery@unimelb.edu.au
Contact person for public queries
Name 104467 0
Shakira MIlton
Address 104467 0
Victorian Comprehensive Cancer Centre
Level 10, 305 Grattan Street, Melbourne, VIC 3000
Country 104467 0
Australia
Phone 104467 0
+61 420506330
Fax 104467 0
Email 104467 0
shakira.milton@unimelb.edu.au
Contact person for scientific queries
Name 104468 0
Shakira MIlton
Address 104468 0
Victorian Comprehensive Cancer Centre
Level 10, 305 Grattan Street, Melbourne, VIC 3000
Country 104468 0
Australia
Phone 104468 0
+61 420506330
Fax 104468 0
Email 104468 0
shakira.milton@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided IPD


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16200Study protocolMilton, 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/s13063-021-05365-8https://doi.org/10.1186/s13063-021-05365-8shakira.milton@unimelb.edu.au
16201Statistical analysis plan  shakira.milton@unimelb.edu.au
16202Statistical analysis plan  shakira.milton@unimelb.edu.au 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
SourceTitleYear of PublicationDOI
EmbaseAn 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.2021https://dx.doi.org/10.1186/s13063-021-05365-8
N.B. These documents automatically identified may not have been verified by the study sponsor.