A community pharmacy intervention development to improve patients’ adherence and quality of life
Annually, 55,900 women are diagnosed with invasive breast cancer. After completing surgery, chemotherapy or radiation, around 44,720 (80%) are prescribed hormone therapy (HT) drugs. These drugs help in preventing the cancer coming back (recurrence) or spreading to other parts of the body (metastasis).
When patients are prescribed HT they take it as a daily tablet, usually for five years and in some cases for up to ten. HT medication produces a considerable amount of side effects: hot flashes, depression, low sexual desire, joint pain, low energy and tiredness among other bothersome symptoms.
There are many factors that influence women to completely stop or not take their HT drugs as indicated. Our preliminary research has identified that changing the medication brand name (generics) can be challenging for patients. This can negatively impact many patients, who experience new or worsening side effects and often encounter disbelief from healthcare professionals when raising concerns. This affects in turn women’s confidence in taking their medication, e.g. when women search for their preferred brand, they do not take the medication or stop taking it if they cannot find a brand that suits them.
We aim to make a meaningful contribution to addressing patients’ concerns with HT generic switching. Supported by a breast cancer patient advisory group and key stakeholders, we will co-produce an intervention to improve medication consultations about HT brand changes.
Project team
Research associate
This project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (NIHR206589).
The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
More information
Hormone therapy (HT) drugs (tamoxifen, letrozole, anastrozole, and exemestane) are prescribed for 5 to 10 years to reduce the risk of recurrence and mortality. These drugs are known to cause several side effects and have been consistently identified in the literature as a key factor of non-adherence and poor quality of life. By the fifth year of treatment, adherence to HT is suboptimal for around 50% of women.
Clinical studies on women’s experiences with HT medications revealed that the use of generic drugs either to replace the proprietary name (generic substitution) or to switch amongst generic brands (generic switching) can have a negative impact on patients’ side effects, attitudes and acceptance of certain generic brands.
Medication concerns undermine patients’ self-efficacy (skills and confidence) for medication-taking behaviours and have an impact on adherence and persistence.
Our intervention addresses key priorities in cancer research identified by the National Cancer Research Institute and the James Lind Alliance urging new interventions to manage long-term side effects, and the NHS Long Term Plan cancer ambitions to improve quality of life, patient experience outcomes, and to reduce inequalities.
The aim of the project is to co-produce with breast cancer patients and pharmacists an intervention to improve medication brand change consultations for women with breast cancer in community pharmacy settings.
Achieving this will identify the communication and advice strategies that can be used by pharmacists in discussing HT medication brands and the delivery of a patient-centred approach that could improve adherence and quality of life. We will assess the acceptability of the intervention to patients and pharmacists to inform the design of a future feasibility study.
Our objectives are to:
- Co-develop intervention content using co-production workshops with patients and pharmacists
- Design and deliver an e-learning resource targeting behaviour change components in pharmacy staff to improve HT medication-taking in women with breast cancer
- Explore with pharmaceutical professional bodies and owners of community pharmacies (chain and independent) the barriers and facilitators of implementing the intervention in community pharmacies
- Assess patient and pharmacist’s perceptions of the intervention and its acceptability
- Integrate feedback to refine the ENABLE intervention and the design of a feasibility study protocol
Our theoretical approach is informed by:
- The Person-Based Approach, an evidence-, theory- and person- based method for developing interventions that focuses on user-centred design to ensure that interventions are as acceptable, engaging, and feasible as possible, and ultimately effective in their implementation
- Co-production research to inform the intervention development process, thus extending the stakeholder involvement in our initial stages of the project
- Behaviour change theory, including the Theoretical Domains Framework for behavioural analysis, and the Behaviour Change Techniques, linked to their mechanism of action in intervention development
The study has obtained a favourable opinion from the NHS Health Research Authority, West Midlands - South Birmingham Research Ethics Committee, reference 24/WM/0137.
Prof. Yolanda Eraso is Professor of Health Studies in the School of Social Sciences and Professions and and Director of the Health and Behaviour Research Centre at London Metropolitan University. She is the Chief Investigator of the ENABLE study. Her expertise is in behavioural approaches to support breast cancer medication adherence.
Prof. Ruth Edwards is Professor of Pharmacy Education at the University of Wolverhampton and a co-applicant. She is an experienced pharmacist and academic with expertise in pharmacy education.
Prof. Duncan Stewart is Professor of Applied Health Research, London Metropolitan University, and co-applicant. He has extensive experience in research about discussing alcohol consumption during medication reviews in community pharmacies.
Carrol Lamouline is Patient and Public Involvement-lead in the ENABLE study. She has participated in many studies representing the patient’s perspective, most recently, as co-chair for the NIHR - Multimorbidity, Patient Data and Artificial Intelligence.
Jacqueline Cochrane is Research Associate. She has a background in health psychology and expertise in the complex impacts of mastectomy on women’s lives beyond physiological recovery. She currently teaches at the Open University.
The web-development team for the e-learning resource is based in the School of Computing and Digital Media, London Metropolitan University:
Patient advisory group: Five breast cancer patients with experience in HT medication provide feedback to different components of the study and plan the dissemination and engagement strategy.
Steering committee: Members include an oncologist, a GP, a breast cancer nurse, an NHS cancer services commissioner, and a breast cancer patient.
Publications
Preliminary work before we started the ENABLE study included an exploration by the Chief Investigator on women’s perspectives of extending HT to 10 years, based on data from patients in an online breast cancer forum. Reading patients’ concerns with treatment continuation is where medication brand changes first emerged as a research topic:
- Eraso, Y., Stefler, D., Moon, Z., Rossi, L., Assefa, S. (2021) Extending adjuvant endocrine therapy for 10 years. A mixed-methods analysis of women’s decision making in an online breast cancer forum. Healthcare. 2021; 9(6):688.
This was followed by a qualitative study exploring breast cancer patients’ experiences with changing medication brands:
- Eraso, Y., Moon, Z., Steinberga, I. Patients' Experience of Medication Brand Changes during Hormone Therapy for Breast Cancer-An Interpretative Phenomenological Analysis. Healthcare. 2022; 10(12):2558.
E-learning resource
We have developed the ENABLE e-learning resource to train community pharmacists on the necessary skills to deliver medication consultations with breast cancer patients concerned with medication brand changes.
Prof. Yolanda Eraso and Prof. Ruth Edwards led on the content for this resource, while a team from London Met's School of Computing and Digital Media developed the web page, videos and animations (Lisa Constantinou, Stefani Mineva, Alexandra Gabriela Leiseca, Sowmya Balasubramanian, and Jaiden Hunter).
This clip shows part of a summary of the content corresponding to one of the blocks of the e-learning.
Find out more
You can read more about the ENABLE study here:
- ISRCTN - The UK’s Clinical Study Registry: ENABLE: Medication brand changes in hormone therapy for breast cancer
- London Met Research Hub: London Met researchers secure grant to help breast cancer patients receive the best treatment
