Planning and Developing a Symptom Diary Intervention for Breast Cancer Survivors With Concerns About Medication Brands (ENABLE Study): User-Centered Design Approach.

backgroundApproximately 80% of breast cancers are estrogen receptor positive, and following initial tumor treatment, patients are prescribed hormone therapy (HT) drugs (tamoxifen, letrozole, anastrozole, and exemestane) for 5-10 years. These drugs are known to cause several side effects. Additionally, a small number of studies have identified that changing medication brands (generics) can negatively affect patients' side effects, attitudes, and acceptance of HT. However, no effective intervention currently exists to address patients' concerns about generic switching.

objectiveThis study explores whether a symptom diary appears to be an acceptable approach for patients and pharmacists to address brand concerns, and provides a detailed report of the planning and development stages of a coproduced diary intervention.

methodsThis paper presents the studies conducted during the planning and development stages of the symptom diary, following the person-based approach, which combines theory-, evidence-, and person-based approaches to ensure interventions are acceptable and easy to implement. The study included the following stages: (1) the planning stage, which involved analysis of an online patient forum (n=277), interviews with patients (n=9), and interviews with pharmacists (n=7). Data triangulation was used to present an integrated set of findings. (2) The development stage, which involved a rapid scoping review of the literature on the use of diaries among patients with cancer, coproduction workshops with patients and pharmacists (n=17), pharmacist interviews (n=11), and consultation with our patient advisory group (n=5). Analysis was informed by evidence synthesis, behavior change analyses, and iterative stakeholder consultations.

resultsIn the intervention planning stage, patients and pharmacists perceived community pharmacies as the ideal setting for HT medication consultations. Both groups proposed using a patient diary to support awareness and attribution of drug-related symptoms. Pharmacists described patients' requests for specific brands as difficult to manage, whereas patients reported that switching brands undermined confidence in medication-taking. In the development stage, the scoping review (n=29 papers) identified barriers and facilitators related to diary use, and workshops explored diary format and content. These findings informed the intervention planning table and the first diary prototype. Pharmacist interviews and patient feedback informed the development of 2 further prototypes. The symptom diary is a self-monitoring tool designed to enhance self-efficacy in HT medication-taking behaviors. It includes recording side effects from brands alongside physical, psychological, and environmental factors; actions taken to manage symptoms; and problem-solving and planning before a medication consultation to facilitate personalized feedback from pharmacists.

conclusionsWe preliminarily developed an intervention that appears engaging, relevant, and acceptable for patients to self-monitor their symptoms. Further revisions informed by user feedback will be incorporated after testing ENABLE (Medication Brand Changes in Hormone Therapy for Breast Cancer: A Community Pharmacy Intervention Development to Improve Patients' Adherence and Quality of Life) in community pharmacies.

trial registrationISRCTN Registry ISRCTN15089342; http://www.isrctn.com/ISRCTN15089342.