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

Green, Sophie M.C. and French, David P. and Graham, Christopher D. and Hall, Louise H. and Rousseau, Nikki and Foy, Robbie and Clark, Jane and Parbutt, Catherine and Raine, Erin and Gardner, Benjamin and Velikova, Galina and Moore, Sally J. L. and Buxton, Jacqueline and Collinson, Michelle and Ellison, Rachel and Wilkes, Hollie and Hartley, Suzanne and Mason, Ellen and Farrin, Amanda and Walwyn, Rebecca and Waller, Jo and Howdon, Daniel and Metherell, Jamie and Smith, Samuel G., ROSETA investigators (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. 1081. ISSN 1472-6963 (https://doi.org/10.1186/s12913-022-08243-4)

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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.

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