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

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

Optimization of an information leaflet to influence medication beliefs in women with breast cancer: a randomized factorial experiment

Most women with breast cancer are prescribed adjuvant endocrine therapy (AET) to prevent recurrence and mortality, but adherence is suboptimal. Negative beliefs about the necessity of AET and high concerns are barriers to adherence. We aimed to optimize the content of an information leaflet intervention, to support AET beliefs. We conducted an online screening experiment using a 2^5 factorial design to optimize the leaflet. The leaflet had five components, each with two levels; 1) diagrams about AET mechanisms (on/off); 2) infographics displaying AET benefits (enhanced/basic); 3) AET side-effects (enhanced/basic); 4) answers to AET concerns (on/off); 5) breast cancer survivor (patient) input: quotes and photographs (on/off). Healthy adult women (n=1604), recruited via a market research company, were randomized to one of 32 experimental conditions, which determined the levels of components received. Participants completed the beliefs about medicines questionnaire before and after viewing the leaflet. Note: This dataset only contains data for the primary outcome (beliefs about AET). A dataset containing secondary outcome data will be shared in due course

Developing theory-based text messages to support retention in clinical trials: A mixed methods approach

Background: Returning a trial questionnaire is a behaviour affected by a range of psychological and contextual factors. Previously tested Short Message Service (SMS) messages to prompt questionnaire return have not addressed these factors, and have not been characterised by established taxonomies of behaviour change techniques (BCTs). Purpose: We aimed to develop acceptable theory-based SMS messages, with fidelity to four BCTs, to support participant understanding of the consequences of not returning trial questionnaires. Methods and Results: We initially developed 32 messages. Ten behaviour change experts assessed message fidelity to the intended BCT (Study 1a). All messages had appropriate fidelity to the intended BCT (mean ratings = 6.8/10 [SD = 0.6) to 7.5/10 [SD = 0.3]). Study 1b, a focus group with five patient representatives, recommended removing the BCT ‘comparative imagining of future outcomes’ (4 messages), two further messages be removed, and amendments to five messages. In Study 1c, 60 breast cancer survivors rated all remaining 26 messages as acceptable (mean = 3.8/5 [SD = 1.2] to 4.3/5 [SD = 0.8]). Twelve behaviour change experts rated the fidelity of the 26 messages to intended BCTs (Study 1d); all messages had appropriate fidelity (mean ratings = 6.1/10 [SD = 2.4] to 6.9/10 [SD = 1.4]). Conclusions: In these studies, we developed 26 SMS messages that were acceptable to the intended recipients and had sufficient fidelity to the intended BCTs. This approach could be taken to design interventions supporting behaviours needed for the successful delivery of clinical trials. The messages are available to research teams who can evaluate them in Studies within Trials

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

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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12913-022-08243-4