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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ABSTRACT: 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 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.
Primary outcome(s): 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.[6 months after enrollment];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. [1-month after enrollment ]
Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy
DISEASE(S): Colorectal Cancer Prevention,Cardiovascular-other Cardiovascular Diseases,Cardiovascular Disease Prevention,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)
PROVIDER: 2471220 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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