Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy

ROSETA investigators; Sophie M.C. Green; David P. French; Christopher D. Graham; Louise H. Hall; Nikki Rousseau; Robbie Foy; Jane Clark; Catherine Parbutt; Erin Raine; Benjamin Gardner; Galina Velikova; Sally J. L. Moore; Jacqueline Buxton; Michelle Collinson; Rachel Ellison; Hollie Wilkes; Suzanne Hartley; Ellen Mason; Amanda Farrin; Rebecca Walwyn; Jo Waller; Daniel Howdon; Jamie Metherell; Samuel G. Smith

doi:10.1186/s12913-022-08243-4

Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy

ROSETA investigators, Sophie M.C. Green, David P. French, Christopher D. Graham, Louise H. Hall, Nikki Rousseau, Robbie Foy, Jane Clark, Catherine Parbutt, Erin Raine, Benjamin Gardner, Galina Velikova, Sally J. L. Moore, Jacqueline Buxton, Michelle Collinson, Rachel Ellison, Hollie Wilkes, Suzanne Hartley, Ellen Mason, Amanda FarrinRebecca Walwyn, Jo Waller, Daniel Howdon, Jamie Metherell, Samuel G. Smith^*

^*Corresponding author for this work

Psychology

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

20 Citations (Scopus)

14 Downloads (Pure)

Abstract

Background: Adjuvant endocrine therapy (AET) reduces the risk of breast cancer recurrence and mortality. However, up to three-quarters of women with breast cancer do not take AET as prescribed. Existing interventions to support adherence to AET have largely been unsuccessful, and have not focused on the most salient barriers to adherence. This paper describes the process of developing four theory-based intervention components to support adherence to AET. Our aim is to provide an exemplar of intervention development using Intervention Mapping (IM) with guidance from the Multiphase Optimisation Strategy (MOST). Methods: Iterative development followed the six-stage IM framework with stakeholder involvement. Stage 1 involved a literature review of barriers to adherence and existing interventions, which informed the intervention objectives outlined in Stage 2. Stage 3 identified relevant theoretical considerations and practical strategies for supporting adherence. Stage 4 used information from Stages 1-3 to develop the intervention components. Stages 1-4 informed a conceptual model for the intervention package. Stages 5 and 6 detailed implementation considerations and evaluation plans for the intervention package, respectively. Results: The final intervention package comprised four individual intervention components: Short Message Service to encourage habitual behaviours surrounding medication taking; an information leaflet to target unhelpful beliefs about AET; remotely delivered Acceptance and Commitment Therapy-based guided self-help to reduce psychological distress; and a website to support self-management of AET side-effects. Considerations for implementation within the NHS, including cost, timing and mode of delivery were outlined, with explanation as to how using MOST can aid this. We detail our plans for the final stage of IM which involve feasibility testing. This involved planning an external exploratory pilot trial using a 2^4-1 fractional factorial design, and a process evaluation to assess acceptability and fidelity of intervention components. Conclusions: We have described a systematic and logical approach for developing a theoretically informed intervention package to support medication adherence in women with breast cancer using AET. Further research to optimise the intervention package, guided by MOST, has the potential to lead to more effective, efficient and scalable interventions.

Original language	English
Article number	1081
Number of pages	21
Journal	BMC Health Services Research
Volume	22
DOIs	https://doi.org/10.1186/s12913-022-08243-4
Publication status	Published - 24 Aug 2022

Funding

This report is independent research supported by the National Institute for Health Research NIHR Advanced Fellowship, Dr. Samuel Smith NIHR300588. DF is funded in part by the NIHR Manchester Biomedical Research Centre (IS-BRC-1215-20007). 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. We would like to thank all patient representatives for their contributions. We would also like to thank Health Creatives at University College London for designing the information leaflet and website intervention components. ROSETA Investigators: Samuel G. Smith1, Sophie M. C. Green1, David P. French2, Christopher D. Graham3, Louise H. Hall1, Nikki Rousseau4, Robbie Foy1, Jane Clark5, Catherine Parbutt5, Erin Raine1, Benjamin Gardner6, Galina Velikova7,8, Sally Moore1, Jacqueline Buxton1, Michelle Collinson4, Rachel Ellison4, Hollie Wilkes4, Suzanne Hartley4, Ellen Mason4, Amanda Farrin4, Rebecca Walwyn4, Jo Waller9, Daniel Howdon10, Jamie Metherell49. Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King’s College London, UK 10. Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK

Keywords

breast cancer
intervention mapping
medication adherence
multiphase optimisation strategy

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ROSETA investigators, Green, S. M. C., French, D. P., Graham, C. D., Hall, L. H., Rousseau, N., Foy, R., Clark, J., Parbutt, C., Raine, E., Gardner, B., Velikova, G., Moore, S. J. L., Buxton, J., Collinson, M., Ellison, R., Wilkes, H., Hartley, S., Mason, E., ... Smith, S. G. (2022). Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy. BMC Health Services Research , 22, Article 1081. https://doi.org/10.1186/s12913-022-08243-4

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title = "Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy",

abstract = "Background: Adjuvant endocrine therapy (AET) reduces the risk of breast cancer recurrence and mortality. However, up to three-quarters of women with breast cancer do not take AET as prescribed. Existing interventions to support adherence to AET have largely been unsuccessful, and have not focused on the most salient barriers to adherence. This paper describes the process of developing four theory-based intervention components to support adherence to AET. Our aim is to provide an exemplar of intervention development using Intervention Mapping (IM) with guidance from the Multiphase Optimisation Strategy (MOST). Methods: Iterative development followed the six-stage IM framework with stakeholder involvement. Stage 1 involved a literature review of barriers to adherence and existing interventions, which informed the intervention objectives outlined in Stage 2. Stage 3 identified relevant theoretical considerations and practical strategies for supporting adherence. Stage 4 used information from Stages 1-3 to develop the intervention components. Stages 1-4 informed a conceptual model for the intervention package. Stages 5 and 6 detailed implementation considerations and evaluation plans for the intervention package, respectively. Results: The final intervention package comprised four individual intervention components: Short Message Service to encourage habitual behaviours surrounding medication taking; an information leaflet to target unhelpful beliefs about AET; remotely delivered Acceptance and Commitment Therapy-based guided self-help to reduce psychological distress; and a website to support self-management of AET side-effects. Considerations for implementation within the NHS, including cost, timing and mode of delivery were outlined, with explanation as to how using MOST can aid this. We detail our plans for the final stage of IM which involve feasibility testing. This involved planning an external exploratory pilot trial using a 24-1 fractional factorial design, and a process evaluation to assess acceptability and fidelity of intervention components. Conclusions: We have described a systematic and logical approach for developing a theoretically informed intervention package to support medication adherence in women with breast cancer using AET. Further research to optimise the intervention package, guided by MOST, has the potential to lead to more effective, efficient and scalable interventions.",

keywords = "breast cancer, intervention mapping, medication adherence, multiphase optimisation strategy",

author = "{ROSETA investigators} and Green, {Sophie M.C.} and French, {David P.} and Graham, {Christopher D.} and Hall, {Louise H.} and Nikki Rousseau and Robbie Foy and Jane Clark and Catherine Parbutt and Erin Raine and Benjamin Gardner and Galina Velikova and Moore, {Sally J. L.} and Jacqueline Buxton and Michelle Collinson and Rachel Ellison and Hollie Wilkes and Suzanne Hartley and Ellen Mason and Amanda Farrin and Rebecca Walwyn and Jo Waller and Daniel Howdon and Jamie Metherell and Smith, {Samuel G.}",

year = "2022",

month = aug,

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doi = "10.1186/s12913-022-08243-4",

language = "English",

volume = "22",

journal = "BMC Health Services Research ",

issn = "1472-6963",

publisher = "BioMed Central",

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ROSETA investigators, Green, SMC, French, DP, Graham, CD, Hall, LH, Rousseau, N, Foy, R, Clark, J, Parbutt, C, Raine, E, Gardner, B, Velikova, G, Moore, SJL, Buxton, J, Collinson, M, Ellison, R, Wilkes, H, Hartley, S, Mason, E, Farrin, A, Walwyn, R, Waller, J, Howdon, D, Metherell, J & Smith, SG 2022, 'Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy', BMC Health Services Research , vol. 22, 1081. https://doi.org/10.1186/s12913-022-08243-4

Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy. / ROSETA investigators; Green, Sophie M.C.; French, David P. et al.
In: BMC Health Services Research , Vol. 22, 1081, 24.08.2022.

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

TY - JOUR

T1 - Supporting adjuvant endocrine therapy adherence in women with breast cancer

T2 - the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy

AU - ROSETA investigators

AU - Green, Sophie M.C.

AU - French, David P.

AU - Graham, Christopher D.

AU - Hall, Louise H.

AU - Rousseau, Nikki

AU - Foy, Robbie

AU - Clark, Jane

AU - Parbutt, Catherine

AU - Raine, Erin

AU - Gardner, Benjamin

AU - Velikova, Galina

AU - Moore, Sally J. L.

AU - Buxton, Jacqueline

AU - Collinson, Michelle

AU - Ellison, Rachel

AU - Wilkes, Hollie

AU - Hartley, Suzanne

AU - Mason, Ellen

AU - Farrin, Amanda

AU - Walwyn, Rebecca

AU - Waller, Jo

AU - Howdon, Daniel

AU - Metherell, Jamie

AU - Smith, Samuel G.

PY - 2022/8/24

Y1 - 2022/8/24

N2 - Background: Adjuvant endocrine therapy (AET) reduces the risk of breast cancer recurrence and mortality. However, up to three-quarters of women with breast cancer do not take AET as prescribed. Existing interventions to support adherence to AET have largely been unsuccessful, and have not focused on the most salient barriers to adherence. This paper describes the process of developing four theory-based intervention components to support adherence to AET. Our aim is to provide an exemplar of intervention development using Intervention Mapping (IM) with guidance from the Multiphase Optimisation Strategy (MOST). Methods: Iterative development followed the six-stage IM framework with stakeholder involvement. Stage 1 involved a literature review of barriers to adherence and existing interventions, which informed the intervention objectives outlined in Stage 2. Stage 3 identified relevant theoretical considerations and practical strategies for supporting adherence. Stage 4 used information from Stages 1-3 to develop the intervention components. Stages 1-4 informed a conceptual model for the intervention package. Stages 5 and 6 detailed implementation considerations and evaluation plans for the intervention package, respectively. Results: The final intervention package comprised four individual intervention components: Short Message Service to encourage habitual behaviours surrounding medication taking; an information leaflet to target unhelpful beliefs about AET; remotely delivered Acceptance and Commitment Therapy-based guided self-help to reduce psychological distress; and a website to support self-management of AET side-effects. Considerations for implementation within the NHS, including cost, timing and mode of delivery were outlined, with explanation as to how using MOST can aid this. We detail our plans for the final stage of IM which involve feasibility testing. This involved planning an external exploratory pilot trial using a 24-1 fractional factorial design, and a process evaluation to assess acceptability and fidelity of intervention components. Conclusions: We have described a systematic and logical approach for developing a theoretically informed intervention package to support medication adherence in women with breast cancer using AET. Further research to optimise the intervention package, guided by MOST, has the potential to lead to more effective, efficient and scalable interventions.

AB - Background: Adjuvant endocrine therapy (AET) reduces the risk of breast cancer recurrence and mortality. However, up to three-quarters of women with breast cancer do not take AET as prescribed. Existing interventions to support adherence to AET have largely been unsuccessful, and have not focused on the most salient barriers to adherence. This paper describes the process of developing four theory-based intervention components to support adherence to AET. Our aim is to provide an exemplar of intervention development using Intervention Mapping (IM) with guidance from the Multiphase Optimisation Strategy (MOST). Methods: Iterative development followed the six-stage IM framework with stakeholder involvement. Stage 1 involved a literature review of barriers to adherence and existing interventions, which informed the intervention objectives outlined in Stage 2. Stage 3 identified relevant theoretical considerations and practical strategies for supporting adherence. Stage 4 used information from Stages 1-3 to develop the intervention components. Stages 1-4 informed a conceptual model for the intervention package. Stages 5 and 6 detailed implementation considerations and evaluation plans for the intervention package, respectively. Results: The final intervention package comprised four individual intervention components: Short Message Service to encourage habitual behaviours surrounding medication taking; an information leaflet to target unhelpful beliefs about AET; remotely delivered Acceptance and Commitment Therapy-based guided self-help to reduce psychological distress; and a website to support self-management of AET side-effects. Considerations for implementation within the NHS, including cost, timing and mode of delivery were outlined, with explanation as to how using MOST can aid this. We detail our plans for the final stage of IM which involve feasibility testing. This involved planning an external exploratory pilot trial using a 24-1 fractional factorial design, and a process evaluation to assess acceptability and fidelity of intervention components. Conclusions: We have described a systematic and logical approach for developing a theoretically informed intervention package to support medication adherence in women with breast cancer using AET. Further research to optimise the intervention package, guided by MOST, has the potential to lead to more effective, efficient and scalable interventions.

KW - breast cancer

KW - intervention mapping

KW - medication adherence

KW - multiphase optimisation strategy

U2 - 10.1186/s12913-022-08243-4

DO - 10.1186/s12913-022-08243-4

M3 - Article

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AN - SCOPUS:85136508720

SN - 1472-6963

VL - 22

JO - BMC Health Services Research

JF - BMC Health Services Research

M1 - 1081

ER -

ROSETA investigators, Green SMC, French DP, Graham CD, Hall LH, Rousseau N et al. Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy. BMC Health Services Research . 2022 Aug 24;22:1081. doi: 10.1186/s12913-022-08243-4