Around 38,500 UK women each year are prescribed hormone-blocking pills after breast cancer surgery, but many stop taking them too early, raising their risk of the cancer returning or proving fatal. This research tackles a persistent and costly problem: low adherence to adjuvant endocrine therapy (AET). Roughly 70% of women with invasive breast cancer are offered AET, yet many do not persist with the daily medication for the full five to ten years. The reasons are varied—forgetfulness, troubling side effects, or doubts about whether the drug is necessary. Current support is patchy and rarely tested rigorously. The researcher will test four low-cost components—SMS reminders, written information, a group-based Acceptance and Commitment Therapy programme, and a self-management website—using a factorial trial design with 404 women. Components that improve adherence by a meaningful amount and remain cost-effective will be bundled into an optimised package. If successful, the intervention could be rolled out across the NHS at minimal cost, reducing recurrence and mortality without requiring new drugs or expensive infrastructure. The programme also prepares a definitive trial to confirm those benefits at scale.
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BACKGROUND Women with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have an increased risk of mortality, recurrence, and reduced quality-adjusted life-years. AET is offered to approximately 70% of women with invasive breast cancer (~38500 UK women per year). Low adherence and persistence is an unsolved and widespread problem. AIMS AND OBJECTIVES To prepare and optimise a low cost complex behavioural intervention to support medication adherence among women taking AET using the Multiphase Optimisation Strategy. My overall goal is focussed on reducing overall mortality and risk of breast cancer recurrence. Objectives: Preparation phase To develop / adapt four intervention components that target determinants of adherence to AET; To pilot an optimisation trial testing these four components in a fractional factorial design with a nested qualitative study; Optimisation phase To optimise the intervention package using a factorial trial design to evaluate which components improve adherence for a maximum pre-specified cost; To undertake a causal pathway analysis to test the conceptual model; To undertake a mixed-methods longitudinal process evaluation to monitor treatment fidelity. Impact and dissemination phase To disseminate and create impact through push, pull, and linkage and exchange activities; To prepare a protocol and funding application for a definitive RCT. METHODS Preparation phase: I will design and evaluate four intervention components that support medication adherence. Components have been selected to target the mechanisms of action within a conceptual model developed using intervention mapping and with patient input: SMS text reminders (target: memory), Written information (target: medication beliefs), A group-based Acceptance and Commitment Therapy (ACT) programme (target: psychological flexibility) Self-management website (target: living with side-effects). The components will be finalised in a series of mixed-methods studies. A pilot trial (n=80) using a 24-1 fractional factorial design with a nested qualitative study will: 1) examine the feasibility of undertaking such a trial within the NHS and 2) ascertain the availability of outcome data. Optimisation phase: I will optimise the intervention components using a 24 factorial trial design (n=404) with an internal pilot. The planned primary outcome is adherence, assessed by NHS dispensing data. Components will be retained within the intervention package if they demonstrate an effect of d≥0.28 with the primary outcome, and the overall package can be delivered for a cost likely to meet NICE cost-effectiveness thresholds ( TIMELINE FOR DELIVERY I will complete the Fellowship over 75 months (0.8FTE) to provide opportunities for development outside the Fellowship, and to accommodate trial follow-up. Preparation phase. Months 1-36 Intervention component development (months 1-6) Pilot 24-1 trial with nested qualitative study (months 1-36) Optimisation phase. Months 25-75 24 factorial trial (25-75) Longitudinal mixed-methods process evaluation (months 46-75) Impact and dissemination. Months 19-75 Push activities (e.g. Publications) (months 19-75) Pull activities (e.g. Parliamentary Fellowship) (months 19-24) Linkage and exchange (e.g. Strengthening stakeholder networks) (months 22-75)
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