Evidence map›Paper›PMID 34256828›Full record

Trial reportTrials2021

Process evaluation of the Bridging the Age Gap in Breast Cancer decision support intervention cluster randomised trial.

Maria Burton, Kate J Lifford, Lynda Wyld, Fiona Armitage, Alistair Ring, Anthony Nettleship, Karen Collins, Jenna Morgan, Malcolm W R Reed, Geoffrey R Holmes and 7 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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. Review
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Maria Burton *College of Health, Wellbeing & Life Sciences, Sheffield Hallam University, Collegiate Crescent, Sheffield, UK.
Kate J Lifford *Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. LiffordKJ@cardiff.ac.uk.ORCID http://orcid.org/0000-0002-9782-2080
Lynda WyldDepartment of Oncology and Metabolism, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.
Fiona ArmitageDepartment of Oncology and Metabolism, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.
Alistair RingBreast Unit, Royal Marsden NHS Foundation Trust, London, UK.
Anthony NettleshipepiGenesys, Floor C, Cathedral Court, 1 Vicar Lane, Sheffield, UK.
Karen CollinsCollege of Health, Wellbeing & Life Sciences, Sheffield Hallam University, Collegiate Crescent, Sheffield, UK.
Jenna MorganDepartment of Oncology and Metabolism, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.
Malcolm W R ReedBrighton and Sussex Medical School, University of Sussex, Falmer, Brighton, UK.
Geoffrey R HolmesDepartment of Health Economics and Decision Science, School for Health and Related Research, University of Sheffield, Sheffield, UK.
Mike BradburnClinical Trials Research Unit, University of Sheffield, ScHARR, 30 Regent Street, Sheffield, UK.
Jacqui GathYorkshire and Humberside (formerly North Trent Cancer Network) Consumer Research Panel UK, Sheffield, UK.
Tracy GreenYorkshire and Humberside (formerly North Trent Cancer Network) Consumer Research Panel UK, Sheffield, UK.
Deirdre RevellYorkshire and Humberside (formerly North Trent Cancer Network) Consumer Research Panel UK, Sheffield, UK.
Kate BrainDivision of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Adrian EdwardsDivision of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Study Management Team

Funding

Programme Grants for Applied Research RP-PG-1209-10071
6 · The paper itself

Abstract

backgroundThe Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial (n = 1339 patients), two decision support interventions (DESIs). Both DESIs were used in the intervention arm and each comprised an online risk prediction model, brief decision aid and information booklet. One DESI supported the decision to have either primary endocrine therapy (PET) or surgery with adjuvant therapies and the second supported the decision to have adjuvant chemotherapy after surgery or not.

methodsSixteen sites were randomly selected to take part in the process evaluation. Multiple methods of data collection were used. Medical Research Council (MRC) guidelines for the evaluation of complex interventions were used.

resultsEighty-two patients, mean age 75.5 (range 70-93), provided data for the process evaluation. Seventy-three interviews were completed with patients. Ten clinicians from six intervention sites took part in telephone interviews. Dose: Ninety-one members of staff in the intervention arm received intervention training. Reach: The online tool was accessed on 324 occasions by 27 clinicians. Reasons for non-use of the online tool were commonly that the patient had already made a decision or that there was no online access in the clinic. Of the 32 women for whom there were data available, fifteen from the intervention arm and six from the usual care arm were offered a choice of treatment. Fidelity: Clinicians used the online tool in different ways, with some using it during the consultation and others checking the online survival estimates before the consultation. Adaptation: There was evidence of adaptation when using the DESIs. A lack of infrastructure, e.g. internet access, was a barrier to the use of the online tool. The brief decision aid was rarely used. Mediators: Shared decision-making: Most patients felt able to contribute to decision-making and expressed high levels of satisfaction with the process. Participants' responses to intervention: Six patients reported the DESIs to be very useful, one somewhat useful and two moderately useful.

conclusionsClinicians who participated were mainly supportive of the interventions and had attempted some adaptations to make the interventions applicable, but there were practical and engagement barriers that led to sub-optimal adoption in routine practice.

trial registrationISRCTN46099296 . Registered on 11 August 2016-retrospectively registered.

Indexed as

Breast NeoplasmsAgedDecision Making, SharedFemaleHumansBreast cancerDecision supportIntervention implementationOlder womenProcess evaluationShared decision-making

Identifiers

PMID34256828
PMCPMC8278730

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.