Evidence map›Paper›PMID 33430950›Full record

ArticleTrials2021

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.

Penelope Schofield, Karla Gough, Amelia Hyatt, Alan White, Mark Frydenberg, Suzanne Chambers, Louisa G Gordon, Robert Gardiner, Declan G Murphy, Lawrence Cavedon and 4 more

Erratum issuedAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Penelope SchofieldDepartment of Psychology, Swinburne University of Technology, Melbourne, Victoria, Australia. pschofield@swin.edu.au.ORCID https://orcid.org/0000-0001-9495-9543
Karla GoughBehavioural Science Unit, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Amelia HyattBehavioural Science Unit, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Alan WhiteBehavioural Science Unit, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Mark FrydenbergDepartment of Urology, Cabrini Institute, Cabrini Health, Malvern, Australia.
Suzanne ChambersFaculty of Health, University of Technology Sydney, Sydney, Australia.
Louisa G GordonPopulation Health Department, Health Economics, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.
Robert GardinerSchool of Medicine, University of Queensland, Brisbane, Queensland, Australia.
Declan G MurphySir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Victoria, Australia.
Lawrence CavedonSchool of Science, RMIT University, Melbourne, Victoria, Australia.
Natalie RichardsBehavioural Science Unit, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Barbara MurphyDepartment of Psychology, The University of Melbourne, Parkville, Victoria, Australia.
Stephen QuinnDepartment of Health Science and Biostatistics, Swinburne University of Technology, Melbourne, Victoria, Australia.
Ilona JuraskovaSchool of Psychology, Faculty of Science, Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), University of Sydney, Sydney, New South Wales, Australia.

Funding

National Health and Medical Research Council 1079720
6 · The paper itself

Abstract

backgroundActive 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.

methodsThree 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 registrationAustralian 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.

Indexed as

Prostatic NeoplasmsQuality of LifeAustraliaDecision MakingDecision Support TechniquesHumansMaleNew ZealandRandomized Controlled Trials as TopicActive surveillanceDecision aidDistressLow-risk prostate cancerManagement decisionQuality of lifeRCTTreatment decision

Identifiers

PMID33430950
PMCPMC7802237

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.