Acceptability, fidelity and implementation of systematic integrated pain management in oncology outpatient services: a process evaluation protocol for a multicentre clustered randomised pilot trial

Introduction: In the UK National Health Service (NHS), most people with cancer are cared for at oncology outpatient services, where there are no standardised procedures for managing pain. As a result, patients with cancer may receive inadequate care for pain. The Cancer Pain-assessment Toolkit for Use in RoutinE oncology outpatient services aims to assess the feasibility of conducting a multicentre cluster-randomised trial of a systematic pain assessment and management programme integrated within routine care at UK NHS oncology outpatient services. This protocol describes an embedded process evaluation that aims to evaluate the acceptability, fidelity and implementation of the intervention and trial procedures.

Methods and analysis: A combination of methods will be used in the process evaluation. Quantitative data on fidelity and intervention implementation will be collected using case report forms completed at sites, capturing details on training, intervention delivery and adherence. Qualitative data on acceptability and trial experience will be collected through semistructured interviews with intervention recipients (participants), intervention deliverers (healthcare professionals), research nurses and intervention champions. Researcher fieldnotes will also document trial acceptability throughout the trial. Quantitative data will be summarised descriptively. Qualitative data will be analysed using thematic analysis, guided by the framework of acceptability.

Ethics and dissemination: The trial received ethical approval from South Yorkshire Research Ethics Committee and Health Research Authority (21/HRA/5245). Site-specific approvals were obtained from the research and innovation offices at Leeds Teaching Hospital and Hull Teaching Hospital. Trial findings will be disseminated through peer-reviewed publications and via participating sites.

Trial registration number: ISRCTN86926298.