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

Shakira Milton; Jennifer McIntosh; Finlay Macrae; Patty Chondros; Lyndal Trevena; Mark Jenkins; Fiona M Walter; Natalie Taylor; Lucy Boyd; Sibel Saya; Napin Karnchanachari; Kitty Novy; Carmody Forbes; Javiera Martinez Gutierrez; Kate Broun; Sara Whitburn; Sarah McGill; George Fishman; Julie Marker; Max Shub; Jon Emery

doi:10.1186/s13063-021-05365-8

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. 2021 Jul 15;22(1):452. doi: 10.1186/s13063-021-05365-8.

Authors

Shakira Milton^{1

2}, Jennifer McIntosh^{3

4}, Finlay Macrae^{5

6}, Patty Chondros³, Lyndal Trevena⁷, Mark Jenkins⁸, Fiona M Walter^{3

9}, Natalie Taylor^{10

11}, Lucy Boyd^{12

3}, Sibel Saya^{12

3}, Napin Karnchanachari^{12

3}, Kitty Novy^{12

3}, Carmody Forbes^{12

3}, Javiera Martinez Gutierrez^{12

3

13}, Kate Broun¹⁴, Sara Whitburn¹⁵, Sarah McGill¹⁶, George Fishman¹⁷, Julie Marker¹⁷, Max Shub¹⁷, Jon Emery^{12

3

9}

Affiliations

¹ Centre for Cancer Research, University of Melbourne, Melbourne, Australia. [email protected].
² Department of General Practice, University of Melbourne, Melbourne, Australia. [email protected].
³ Department of General Practice, University of Melbourne, Melbourne, Australia.
⁴ Department of Software Systems & Cybersecurity, Monash University, Melbourne, Australia.
⁵ Colorectal Medicine and Genetics, The Royal Melbourne Hospital, Melbourne, Australia.
⁶ Department of Medicine, The University of Melbourne, Melbourne, Australia.
⁷ Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, Australia.
⁸ Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.
⁹ The Primary Care Unit, University of Cambridge, Cambridge, UK.
¹⁰ Behavioral and Implementation Research and Evaluation, Cancer Council NSW, New South Wales, Australia.
¹¹ Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
¹² Centre for Cancer Research, University of Melbourne, Melbourne, Australia.
¹³ Department of Family Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.
¹⁴ Early Detection and Immunisation, Prevention Department, Cancer Council Victoria, Melbourne, Australia.
¹⁵ Belmore Road Medical Clinic, Melbourne, Australia.
¹⁶ Cancer Screening and Prevention, Cancer Institute NSW, St Leonards, Australia.
¹⁷ Primary Care Collaborative Cancer Clinical Trials Group (PC4), Community Advisory Group, University of Melbourne, Melbourne, Australia.

Abstract

Background: Australian guidelines recommend that all people aged 50-70 years old actively consider taking daily low-dose aspirin (100-300 mg per day) for 2.5 to 5 years to reduce their risk of colorectal cancer (CRC). Despite the change of national CRC prevention guidelines, there has been no active implementation of the guidelines into clinical practice. We aim to test the efficacy of a health consultation and decision aid, using a novel expected frequency tree (EFT) to present the benefits and harms of low dose aspirin prior to a general practice consultation with patients aged 50-70 years, on informed decision-making and uptake of aspirin.

Methods: Approximately five to seven general practices in Victoria, Australia, will be recruited to participate. Patients 50-70 years old, attending an appointment with their general practitioner (GP) for any reason, will be invited to participate in the trial. Two hundred fifty-eight eligible participants will be randomly allocated 1:1 to intervention or active control arms using a computer-generated allocation sequence stratified by general practice, sex, and mode of trial delivery (face-to-face or teletrial). There are two co-primary outcomes: informed decision-making at 1-month post randomisation, measured by the Multi-dimensional Measure of Informed Choice (MMIC), and self-reported daily use of aspirin at 6 months. Secondary outcomes include decisional conflict at 1-month and other behavioural changes to reduce CRC risk at both time points.

Discussion: This trial will test the efficacy of novel methods for implementing national guidelines to support informed decision-making about taking aspirin in 50-70-year-olds to reduce the risk of CRC and other chronic diseases.

Trial registration: The Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001003965 . Registered on 10 October 2020.

Keywords: Aspirin; Bowel cancer; Cancer prevention; Chemoprevention; Colorectal cancer; Decision Aid; General practice; Guideline implementation; Informed decision making; Preventive medicine; Primary care.

Publication types

Clinical Trial Protocol

MeSH terms

Aged
Aspirin* / adverse effects
Chronic Disease
Colorectal Neoplasms* / diagnosis
Colorectal Neoplasms* / prevention & control
Decision Support Techniques
Humans
Middle Aged
Randomized Controlled Trials as Topic
Victoria

Substances

Aspirin

Grants and funding

CPSRG19011/Victorian Cancer Agency