PMID- 34256828 OWN - NLM STAT- MEDLINE DCOM- 20210715 LR - 20210717 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 22 IP - 1 DP - 2021 Jul 13 TI - Process evaluation of the Bridging the Age Gap in Breast Cancer decision support intervention cluster randomised trial. PG - 447 LID - 10.1186/s13063-021-05360-z [doi] LID - 447 AB - BACKGROUND: The 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. METHODS: Sixteen 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. RESULTS: Eighty-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. CONCLUSIONS: Clinicians 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 REGISTRATION: ISRCTN46099296 . Registered on 11 August 2016-retrospectively registered. CI - (c) 2021. The Author(s). FAU - Burton, Maria AU - Burton M AD - College of Health, Wellbeing & Life Sciences, Sheffield Hallam University, Collegiate Crescent, Sheffield, UK. FAU - Lifford, Kate J AU - Lifford KJ AUID- ORCID: 0000-0002-9782-2080 AD - Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. LiffordKJ@cardiff.ac.uk. FAU - Wyld, Lynda AU - Wyld L AD - Department of Oncology and Metabolism, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK. FAU - Armitage, Fiona AU - Armitage F AD - Department of Oncology and Metabolism, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK. FAU - Ring, Alistair AU - Ring A AD - Breast Unit, Royal Marsden NHS Foundation Trust, London, UK. FAU - Nettleship, Anthony AU - Nettleship A AD - epiGenesys, Floor C, Cathedral Court, 1 Vicar Lane, Sheffield, UK. FAU - Collins, Karen AU - Collins K AD - College of Health, Wellbeing & Life Sciences, Sheffield Hallam University, Collegiate Crescent, Sheffield, UK. FAU - Morgan, Jenna AU - Morgan J AD - Department of Oncology and Metabolism, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK. FAU - Reed, Malcolm W R AU - Reed MWR AD - Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, UK. FAU - Holmes, Geoffrey R AU - Holmes GR AD - Department of Health Economics and Decision Science, School for Health and Related Research, University of Sheffield, Sheffield, UK. FAU - Bradburn, Mike AU - Bradburn M AD - Clinical Trials Research Unit, University of Sheffield, ScHARR, 30 Regent Street, Sheffield, UK. FAU - Gath, Jacqui AU - Gath J AD - Yorkshire and Humberside (formerly North Trent Cancer Network) Consumer Research Panel UK, Sheffield, UK. FAU - Green, Tracy AU - Green T AD - Yorkshire and Humberside (formerly North Trent Cancer Network) Consumer Research Panel UK, Sheffield, UK. FAU - Revell, Deirdre AU - Revell D AD - Yorkshire and Humberside (formerly North Trent Cancer Network) Consumer Research Panel UK, Sheffield, UK. FAU - Brain, Kate AU - Brain K AD - Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. FAU - Edwards, Adrian AU - Edwards A AD - Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. CN - Study Management Team LA - eng GR - RP-PG-1209-10071/Programme Grants for Applied Research/ PT - Journal Article PT - Randomized Controlled Trial DEP - 20210713 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Aged MH - *Breast Neoplasms/therapy MH - Decision Making, Shared MH - Female MH - Humans PMC - PMC8278730 OTO - NOTNLM OT - Breast cancer OT - Decision support OT - Intervention implementation OT - Older women OT - Process evaluation OT - Shared decision-making COIS- The authors declare no conflict of interest. Professors Thompson Robinson and Stephen Walters are National Institute for Health Research (NIHR) Senior Investigators and Jenna Morgan is a NIHR Clinical Lecturer. FIR - Harder, Helena IR - Harder H FIR - Ward, Susan IR - Ward S FIR - Richards, Paul IR - Richards P FIR - Martin, Charlene IR - Martin C FIR - Chater, Tim IR - Chater T FIR - Pemberton, Kirsty IR - Pemberton K FIR - Murray, Christopher IR - Murray C FIR - Walters, Stephen IR - Walters S FIR - Herbert, Esther IR - Herbert E FIR - Robinson, Thompson IR - Robinson T FIR - Cheung, Kwok Leung IR - Cheung KL FIR - Audisio, Riccardo IR - Audisio R EDAT- 2021/07/15 06:00 MHDA- 2021/07/16 06:00 PMCR- 2021/07/13 CRDT- 2021/07/14 05:40 PHST- 2020/09/02 00:00 [received] PHST- 2021/06/07 00:00 [accepted] PHST- 2021/07/14 05:40 [entrez] PHST- 2021/07/15 06:00 [pubmed] PHST- 2021/07/16 06:00 [medline] PHST- 2021/07/13 00:00 [pmc-release] AID - 10.1186/s13063-021-05360-z [pii] AID - 5360 [pii] AID - 10.1186/s13063-021-05360-z [doi] PST - epublish SO - Trials. 2021 Jul 13;22(1):447. doi: 10.1186/s13063-021-05360-z.