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. 2023 Aug:70:32-40.
doi: 10.1016/j.breast.2023.05.007. Epub 2023 May 27.

Development of the HT&Me intervention to support women with breast cancer to adhere to adjuvant endocrine therapy and improve quality of life

Affiliations

Development of the HT&Me intervention to support women with breast cancer to adhere to adjuvant endocrine therapy and improve quality of life

Sarah-Jane F Stewart et al. Breast. 2023 Aug.

Abstract

Background: Breast cancer is the most common cancer in women worldwide. Approximately 80% of breast cancers are oestrogen receptor positive (ER+). Patients treated surgically are usually recommended adjuvant endocrine therapy (AET) for 5-10 years. AET significantly reduces recurrence, but up to 50% of women do not take it as prescribed.

Objective: To co-design and develop an intervention to support AET adherence and improve health-related quality-of-life (QoL) in women with breast cancer.

Methods: Design and development of the HT&Me intervention took a person-based approach and was guided by the Medical Research Council framework for complex interventions, based on evidence and underpinned by theory. Literature reviews, behavioural analysis, and extensive key stakeholder involvement informed 'guiding principles' and the intervention logic model. Using co-design principles, a prototype intervention was developed and refined.

Results: The blended tailored HT&Me intervention supports women to self-manage their AET. It comprises initial and follow-up consultations with a trained nurse, supported with an animation video, a web-app and ongoing motivational 'nudge' messages. It addresses perceptual (e.g. doubts about necessity, treatment concerns) and practical (e.g. forgetting) barriers to adherence and provides information, support and behaviour change techniques to improve QoL. Iterative patient feedback maximised feasibility, acceptability, and likelihood of maintaining adherence; health professional feedback maximised likelihood of scalability.

Conclusions: HT&Me has been systematically and rigorously developed to promote AET adherence and improve QoL, and is complemented with a logic model documenting hypothesized mechanisms of action. An ongoing feasibility trial will inform a future randomised control trial of effectiveness and cost-effectiveness.

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Conflict of interest statement

Declaration of competing interest VH reports private work conducted with Bioderma, Lilly, Medscape, Roche and Digistain. RH reports speaker engagement with honoraria for AbbVie, Abbott, Amgen, Astellas, AstraZeneca, Boehringer Ingelheim, Biogen, Gilead Sciences, GlaxoSmithKline, Janssen, Merck Sharp Dohme, Merck, Novartis, Pfizer, Procter & Gamble, Roche, Sanofi, Shire Pharmaceuticals, TEVA, UCB, personal consultancy for Amgen, Abbott, AstraZeneca and Novartis. He is the Founding Director of a UCL-Business company (Spoonful of Sugar Ltd) providing consultancy on treatment engagement and patient support programmes to healthcare policy makers, providers and pharmaceutical industry. ZM reports paid work for UCL Business Company Spoonful of Sugar Ltd.

Figures

Fig. 1
Fig. 1
An overview of the HT&Me intervention development process.
Fig. 2
Fig. 2
The HT&Me logic model of change.

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