Supporting endocrine therapy adherence in women with breast cancer: findings from the ROSETA pilot fractional factorial randomized trial

Samuel G. Smith; Sophie M.C. Green; Emma McNaught; Christopher D. Graham; Robbie Foy; Pei Loo Ow; David P. French; Louise H. Hall; Hollie Wilkes; Christopher Taylor; Rachel Ellison; Erin Raine; Rebecca Walwyn; Daniel Howdon; Jane Clark; Nikki Rousseau; Jacqueline Buxton; Sally J.L. Moore; Jo Waller; Catherine Parbutt; Galina Velikova; Amanda Farrin; Michelle Collinson

doi:10.1093/abm/kaaf003

Supporting endocrine therapy adherence in women with breast cancer: findings from the ROSETA pilot fractional factorial randomized trial

Samuel G. Smith, Sophie M.C. Green, Emma McNaught, Christopher D. Graham, Robbie Foy, Pei Loo Ow, David P. French, Louise H. Hall, Hollie Wilkes, Christopher Taylor, Rachel Ellison, Erin Raine, Rebecca Walwyn, Daniel Howdon, Jane Clark, Nikki Rousseau, Jacqueline Buxton, Sally J.L. Moore, Jo Waller, Catherine ParbuttGalina Velikova, Amanda Farrin, Michelle Collinson

Psychology

Research output: Contribution to journal › Article › peer-review

Abstract

Adherence to adjuvant endocrine therapy (AET) in women with breast cancer is poor. Multicomponent intervention packages are needed to address adherence barriers. Optimizing these packages prior to definitive evaluation can increase their effectiveness, affordability, scalability, and efficiency. To pilot procedures for an optimization-randomized controlled trial (O-RCT) of the 'Refining and Optimizing Strategies to support Endocrine Therapy Adherence' (ROSETA) intervention. This was a multisite individually randomized external pilot trial using a 24-1 fractional factorial design (ISRCTN10487576). Breast cancer survivors prescribed AET were recruited from 5 hospitals and randomized to one of 8 conditions, each comprising a combination of 4 intervention components set to "on" or "off" (SMS messages, information leaflet, guided self-help, and self-management website). We set criteria to inform the decision to progress to an O-RCT for consent rate, component adherence, and availability of outcome measures, with predefined cutoffs for "green" (proceed), "amber" (minor changes), and "red" (major changes). Among 141 eligible patients, 54 (38.3%) consented (green range). At least 50.0% of participants adhered to the minimum threshold set for each intervention component (green range). Data for one of the 3 medication adherence measures were available (amber range). Most (86.8%) participants were satisfied with their trial experience. Exploratory analysis indicated some evidence of a negative main effect of the information leaflet on medication adherence (adjusted mean difference = 0.088, 95% CI, 0.018, 0.158). Progression to a fully powered O-RCT of the ROSETA intervention package is feasible, but review of medication adherence measures is required.

Original language	English
Article number	kaaf003
Number of pages	12
Journal	Annals of Behavioural Medicine
Volume	59
Issue number	1
DOIs	https://doi.org/10.1093/abm/kaaf003
Publication status	Published - 31 Jan 2025

Funding

This report is independent research supported by the National Institute for Health Research NIHR Advanced Fellowship, S.G.S. NIHR300588. S.G.S. also acknowledges funding support from a Yorkshire Cancer Research University Academic Fellowship (L389SS). D.F. is funded in part by the NIHR Manchester Biomedical Research Centre (IS-BRC-1215-20007 and NIHR203308). C.G. acknowledges funding support from NIHR Health Technology Assessment (NIHR134141; NIHR134257), and NIHR Programme Grants for Applied Research (RP-PG-1016-20005). R.F. acknowledges funding support from NIHR Health and Social Care Delivery Research (NIHR151848; NIHR158442; NIHR155714; NIHR131948), NIHR Patient Safety Research Collaboration (NIHR204293), NIHR Applied Research Collaboration (NIHR200166), NIHR Blood Transfusion Research Unit (NIHR203334), and NIHR Programme Grants for Applied Research (RP-PG-0216-20003). R.W. acknowledges funding from an NIHR Advanced Fellowship (NIHR301709). M.C. acknowledges funding support from Macmillan Cancer Support (6488035) Yorkshire Cancer Research (L417, L426, L428), Breast Cancer Now (2019DecPR1367), British Lung Foundation (APP11/1), NIHR Research for Patient Benefit (PB-PG-0816-20015), NIHR Programme Grants for Applied Research (RP-PG-1016-20007, RP-PG-0216-20003), NIHR Public Health Research (NIHR135081), NIHR Health Technology Assessment (15/43/07, NIHR155936). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The funders had no role in the design of the study, data collection, analysis, interpretation of data, and in the writing of this manuscript.

Keywords

breast cancer
endocrine therapy
medication adherence

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

Smith, S. G., Green, S. M. C., McNaught, E., Graham, C. D., Foy, R., Ow, P. L., French, D. P., Hall, L. H., Wilkes, H., Taylor, C., Ellison, R., Raine, E., Walwyn, R., Howdon, D., Clark, J., Rousseau, N., Buxton, J., Moore, S. J. L., Waller, J., ... Collinson, M. (2025). Supporting endocrine therapy adherence in women with breast cancer: findings from the ROSETA pilot fractional factorial randomized trial. Annals of Behavioural Medicine , 59(1), Article kaaf003. https://doi.org/10.1093/abm/kaaf003

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abstract = "Adherence to adjuvant endocrine therapy (AET) in women with breast cancer is poor. Multicomponent intervention packages are needed to address adherence barriers. Optimizing these packages prior to definitive evaluation can increase their effectiveness, affordability, scalability, and efficiency. To pilot procedures for an optimization-randomized controlled trial (O-RCT) of the 'Refining and Optimizing Strategies to support Endocrine Therapy Adherence' (ROSETA) intervention. This was a multisite individually randomized external pilot trial using a 24-1 fractional factorial design (ISRCTN10487576). Breast cancer survivors prescribed AET were recruited from 5 hospitals and randomized to one of 8 conditions, each comprising a combination of 4 intervention components set to {"}on{"} or {"}off{"} (SMS messages, information leaflet, guided self-help, and self-management website). We set criteria to inform the decision to progress to an O-RCT for consent rate, component adherence, and availability of outcome measures, with predefined cutoffs for {"}green{"} (proceed), {"}amber{"} (minor changes), and {"}red{"} (major changes). Among 141 eligible patients, 54 (38.3%) consented (green range). At least 50.0% of participants adhered to the minimum threshold set for each intervention component (green range). Data for one of the 3 medication adherence measures were available (amber range). Most (86.8%) participants were satisfied with their trial experience. Exploratory analysis indicated some evidence of a negative main effect of the information leaflet on medication adherence (adjusted mean difference = 0.088, 95% CI, 0.018, 0.158). Progression to a fully powered O-RCT of the ROSETA intervention package is feasible, but review of medication adherence measures is required.",

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Smith, SG, Green, SMC, McNaught, E, Graham, CD, Foy, R, Ow, PL, French, DP, Hall, LH, Wilkes, H, Taylor, C, Ellison, R, Raine, E, Walwyn, R, Howdon, D, Clark, J, Rousseau, N, Buxton, J, Moore, SJL, Waller, J, Parbutt, C, Velikova, G, Farrin, A & Collinson, M 2025, 'Supporting endocrine therapy adherence in women with breast cancer: findings from the ROSETA pilot fractional factorial randomized trial', Annals of Behavioural Medicine , vol. 59, no. 1, kaaf003. https://doi.org/10.1093/abm/kaaf003

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T1 - Supporting endocrine therapy adherence in women with breast cancer

T2 - findings from the ROSETA pilot fractional factorial randomized trial

AU - Smith, Samuel G.

AU - Green, Sophie M.C.

AU - McNaught, Emma

AU - Graham, Christopher D.

AU - Foy, Robbie

AU - Ow, Pei Loo

AU - French, David P.

AU - Hall, Louise H.

AU - Wilkes, Hollie

AU - Taylor, Christopher

AU - Ellison, Rachel

AU - Raine, Erin

AU - Walwyn, Rebecca

AU - Howdon, Daniel

AU - Clark, Jane

AU - Rousseau, Nikki

AU - Buxton, Jacqueline

AU - Moore, Sally J.L.

AU - Waller, Jo

AU - Parbutt, Catherine

AU - Velikova, Galina

AU - Farrin, Amanda

AU - Collinson, Michelle

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N2 - Adherence to adjuvant endocrine therapy (AET) in women with breast cancer is poor. Multicomponent intervention packages are needed to address adherence barriers. Optimizing these packages prior to definitive evaluation can increase their effectiveness, affordability, scalability, and efficiency. To pilot procedures for an optimization-randomized controlled trial (O-RCT) of the 'Refining and Optimizing Strategies to support Endocrine Therapy Adherence' (ROSETA) intervention. This was a multisite individually randomized external pilot trial using a 24-1 fractional factorial design (ISRCTN10487576). Breast cancer survivors prescribed AET were recruited from 5 hospitals and randomized to one of 8 conditions, each comprising a combination of 4 intervention components set to "on" or "off" (SMS messages, information leaflet, guided self-help, and self-management website). We set criteria to inform the decision to progress to an O-RCT for consent rate, component adherence, and availability of outcome measures, with predefined cutoffs for "green" (proceed), "amber" (minor changes), and "red" (major changes). Among 141 eligible patients, 54 (38.3%) consented (green range). At least 50.0% of participants adhered to the minimum threshold set for each intervention component (green range). Data for one of the 3 medication adherence measures were available (amber range). Most (86.8%) participants were satisfied with their trial experience. Exploratory analysis indicated some evidence of a negative main effect of the information leaflet on medication adherence (adjusted mean difference = 0.088, 95% CI, 0.018, 0.158). Progression to a fully powered O-RCT of the ROSETA intervention package is feasible, but review of medication adherence measures is required.

AB - Adherence to adjuvant endocrine therapy (AET) in women with breast cancer is poor. Multicomponent intervention packages are needed to address adherence barriers. Optimizing these packages prior to definitive evaluation can increase their effectiveness, affordability, scalability, and efficiency. To pilot procedures for an optimization-randomized controlled trial (O-RCT) of the 'Refining and Optimizing Strategies to support Endocrine Therapy Adherence' (ROSETA) intervention. This was a multisite individually randomized external pilot trial using a 24-1 fractional factorial design (ISRCTN10487576). Breast cancer survivors prescribed AET were recruited from 5 hospitals and randomized to one of 8 conditions, each comprising a combination of 4 intervention components set to "on" or "off" (SMS messages, information leaflet, guided self-help, and self-management website). We set criteria to inform the decision to progress to an O-RCT for consent rate, component adherence, and availability of outcome measures, with predefined cutoffs for "green" (proceed), "amber" (minor changes), and "red" (major changes). Among 141 eligible patients, 54 (38.3%) consented (green range). At least 50.0% of participants adhered to the minimum threshold set for each intervention component (green range). Data for one of the 3 medication adherence measures were available (amber range). Most (86.8%) participants were satisfied with their trial experience. Exploratory analysis indicated some evidence of a negative main effect of the information leaflet on medication adherence (adjusted mean difference = 0.088, 95% CI, 0.018, 0.158). Progression to a fully powered O-RCT of the ROSETA intervention package is feasible, but review of medication adherence measures is required.

KW - breast cancer

KW - endocrine therapy

KW - medication adherence

U2 - 10.1093/abm/kaaf003

DO - 10.1093/abm/kaaf003

M3 - Article

SN - 0883-6612

VL - 59

JO - Annals of Behavioural Medicine

JF - Annals of Behavioural Medicine

IS - 1

M1 - kaaf003

ER -

Supporting endocrine therapy adherence in women with breast cancer: findings from the ROSETA pilot fractional factorial randomized trial

Abstract

Funding

Keywords

UN SDGs

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