TY - JOUR
T1 - An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases
T2 - a study protocol for the SITA (Should I Take Aspirin?) trial
AU - Milton, Shakira
AU - McIntosh, Jennifer
AU - Macrae, Finlay
AU - Chondros, Patty
AU - Trevena, Lyndal
AU - Jenkins, Mark
AU - Walter, Fiona M.
AU - Taylor, Natalie
AU - Boyd, Lucy
AU - Saya, Sibel
AU - Karnchanachari, Napin
AU - Novy, Kitty
AU - Forbes, Carmody
AU - Gutierrez, Javiera Martinez
AU - Broun, Kate
AU - Whitburn, Sara
AU - McGill, Sarah
AU - Fishman, George
AU - Marker, Julie
AU - Shub, Max
AU - Emery, Jon
N1 - Funding Information:
The Primary Care Collaborative Cancer Clinical Trials Group (PC4) has a well-established communication strategy that would include the following: media releases to a health professional and general outlets; Twitter and other social media outlets; PC4 Research Round-up and other health professional and general podcasts; dissemination via the PC4 Consumer Advisory Group and their respective consumer networks. We would use all these approaches to promote the trial results and the decision aid. In addition, at the end of the trial we will hold a Think Tank involving key researchers, clinicians (e.g. GPs, gastroenterologists, practice nurses) and their representative colleges (RACGP, ACCRM, GESA, APNA), consumers and consumer organisations (e.g. Cancer Council Victoria, Bowel Cancer Australia), and health policy makers from the Victorian Department of Health and Human Services Prevention and Population Health Branch, Cancer Institute NSW, and Cancer Australia. We will specifically identify and invite representatives of rural GPs and consumers. At this event, we would present the key findings of the research and plan a range of strategies to promote the results and their uptake into practice. The Think Tank would be funded by PC4.
Funding Information:
The authors would like to acknowledge Primary Care Collaborative Cancer Clinical Trials Group (PC4) for supporting this project. They also acknowledge support by the CanTest Collaborative (funded by Cancer Research UK, C8640/A23385) of which Sibel Saya is affiliated researcher, Jon Emery is an Associate Director and Fiona M. Walter is Director. JE conceived of the study and developed the initial trial design. SM, JM, FM, PC, LT, MJ, FMW, NT, LB, SS, NK, KN, CF, JMG, KB, SW, SM, GF, JM, MS contributed to the study design. JE, MJ, LT, FW, FM, JM, SS, PC, and SM are the grant holders. PC provided statistical expertise in clinical trial design. All authors contributed to refinement of the study protocol and approved the final manuscript This study is funded by a dedicated grant from the Victorian Cancer Agency ID: CPSRG19011. See Supplementary file K for a copy of the original funding document. The University of Melbourne is the sponsor of the present trial. The sponsor had no role in the study design and will not have role or authority during the collection, management, analysis, and interpretation of data, and in the decision to submit the results for publication. The PhD candidate and trial statistician will have access to the final trial dataset.
Funding Information:
The authors would like to acknowledge Primary Care Collaborative Cancer Clinical Trials Group (PC4) for supporting this project. They also acknowledge support by the CanTest Collaborative (funded by Cancer Research UK, C8640/A23385) of which Sibel Saya is affiliated researcher, Jon Emery is an Associate Director and Fiona M. Walter is Director.
Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/7/15
Y1 - 2021/7/15
N2 - 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.
AB - 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.
KW - Aspirin
KW - Bowel cancer
KW - Cancer prevention
KW - Chemoprevention
KW - Colorectal cancer
KW - Decision Aid
KW - General practice
KW - Guideline implementation
KW - Informed decision making
KW - Preventive medicine
KW - Primary care
UR - https://www.scopus.com/pages/publications/85110205829
U2 - 10.1186/s13063-021-05365-8
DO - 10.1186/s13063-021-05365-8
M3 - Article
C2 - 34266464
AN - SCOPUS:85110205829
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 452
ER -
SDG 3 Good Health and Well-being