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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001003965
Acronym
SITA
Enrollment
264
Registered
2020-10-06
Start date
2020-10-12
Completion date
2021-04-22
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

The University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

Eligible patients will be aged 50-70, able to read English and competent to give informed consent.

Exclusion criteria

People with contraindications to aspirin (e.g. previous peptic ulcer, taking anticoagulants) or those using aspirin regularly will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 16, 2026