Process evaluation of the bridging the age gap in breast cancer decision support intervention cluster randomised trial (ABSTRACT ONLY)

Introduction: The Age Gap cluster randomised trial sought to test‘complex’’ decision-support interventions (DESIs which included an online decision tool, a brief decision aid (BDA) and a booklet for patients facing a treatment choice of either: 1. surgery ? endocrine therapy (ET) versus primary endocrine therapy (PET), for frail older women; or, 2. adjuvant chemotherapy or no chemotherapy for women having had surgery for high recurrence risk breast cancer. A process evaluation (PE) was undertaken to identify how the interventions worked and aid interpretation of the trial results. Aim: Of the PE were to understand how the DESIs were implemented, the barriers and facilitators, and how acceptable and useful they were to staff and patients. Methods: Multiple methods of data collection were used: questionnaires, interviews, case report forms (CRFs) and audio-recording of consultations. Of 46 trial recruiting sites, 16 were PE sites. Interviews were analysed using a Framework approach. Numeric data were analysed using SPSS. Results: The trial included 1321 participants, 176 from PE sites were invited to participate; 77 patients provided data for the PE. Ten healthcare professionals (HCPs) took part in a telephone interview and seven in audio-recorded consultations. The online tool was used by surgeons in ways personalised to the patient and their own practice and, provided structure to guide treatment options. The booklets were introduced predominantly by nursing staff, with the BDA used as a summary sheet rather than to stimulate discussion as intended. The information provided encouraged more active involvement in decision making. Barriers to implementation were seeing the DESIs as time consuming as well as logistical problems e.g. access to computers. Conclusion: Patient and HCPs feedback on the tools was positive but utilisation was variable both between centres and clinicians. Adoption was hindered by other information materials commonly provided to patients, time and IT constraints.