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dc.contributor.authorSchofield, Penelope
dc.contributor.authorGough, Karla
dc.contributor.authorHyatt, Amelia
dc.contributor.authorWhite, Alan
dc.contributor.authorFrydenberg, Mark
dc.contributor.authorChambers, Suzanne
dc.contributor.authorGordon, Louisa G
dc.contributor.authorGardiner, Robert
dc.contributor.authorMurphy, Declan G
dc.contributor.authorCavedon, Lawrence
dc.contributor.authorRichards, Natalie
dc.contributor.authorMurphy, Barbara
dc.contributor.authorQuinn, Stephen
dc.contributor.authorJuraskova, Ilona
dc.date.accessioned2021-02-22T22:48:27Z
dc.date.available2021-02-22T22:48:27Z
dc.date.issued2021
dc.identifier.issn1745-6215
dc.identifier.doi10.1186/s13063-020-04986-9
dc.identifier.urihttp://hdl.handle.net/10072/402482
dc.description.abstractBackground: Active surveillance (AS) is the disease management option of choice for low-risk prostate cancer. Despite this, men with low-risk prostate cancer (LRPC) find management decisions distressing and confusing. We developed Navigate, an online decision aid to help men and their partners make management decisions consistent with their values. The aims are to evaluate the impact of Navigate on uptake of AS; decision-making preparedness; decisional conflict, regret and satisfaction; quality of illness communication; and prostate cancer-specific quality of life and anxiety. In addition, the healthcare cost impact, cost-effectiveness and patterns of use of Navigate will be assessed. This paper describes the study protocol. Methods: Three hundred four men and their partners are randomly assigned one-to-one to Navigate or to the control arm. Randomisation is electronically generated and stratified by site. Navigate is an online decision aid that presents up-to-date, unbiased information on LRPC tailored to Australian men and their partners including each management option and potential side-effects, and an interactive values clarification exercise. Participants in the control arm will be directed to the website of Australia’s peak national body for prostate cancer. Eligible patients will be men within 3 months of being diagnosed with LRPC, aged 18 years or older, and who are yet to make a treatment decision, who are deemed eligible for AS by their treating clinician and who have Internet access and sufficient English to participate. The primary outcome is self-reported uptake of AS as the first-line management option. Secondary outcomes include self-reported preparedness for decision-making; decisional conflict, regret and satisfaction; quality of illness communication; and prostate cancer-specific quality of life. Uptake of AS 1 month after consent will be determined through patient self-report. Men and their partners will complete study outcome measures before randomisation and 1, 3 and 6 months after study consent. Discussion: The Navigate online decision aid has the potential to increase the choice of AS in LRPC, avoiding or delaying unnecessary radical treatments and associated side effects. In addition, Navigate is likely to reduce patients’ and partners’ confusion and distress in management decision-making and increase their quality of life. Trial registration: Australian and New Zealand Clinical Trial Registry ACTRN12616001665426. Registered on 2 December 2016. All items from the WHO Trial Registration Data set can be found in this manuscript.
dc.description.peerreviewedYes
dc.languageen
dc.publisherSpringer Science and Business Media LLC
dc.relation.ispartofissue1
dc.relation.ispartofjournalTrials
dc.relation.ispartofvolume22
dc.subject.fieldofresearchOncology and Carcinogenesis
dc.subject.fieldofresearchCardiorespiratory Medicine and Haematology
dc.subject.fieldofresearchClinical Sciences
dc.subject.fieldofresearchcode1112
dc.subject.fieldofresearchcode1102
dc.subject.fieldofresearchcode1103
dc.titleNavigate: a study protocol for a randomised controlled trial of an online treatment decision aid for men with low-risk prostate cancer and their partners
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationSchofield, P; Gough, K; Hyatt, A; White, A; Frydenberg, M; Chambers, S; Gordon, LG; Gardiner, R; Murphy, DG; Cavedon, L; Richards, N; Murphy, B; Quinn, S; Juraskova, I, Navigate: a study protocol for a randomised controlled trial of an online treatment decision aid for men with low-risk prostate cancer and their partners, Trials, 2021, 22 (1)
dcterms.licensehttp://creativecommons.org/licenses/by/4.0/
dc.date.updated2021-02-22T22:09:41Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© The Author(s). 2021, corrected publication 2021. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
gro.hasfulltextFull Text
gro.griffith.authorChambers, Suzanne K.


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