Investigation of an integrated standardised pain assessment and management tool in addition to usual care versus usual care alone in oncology outpatient clinics for adults with pain: the CAPTURE cluster randomised pilot trial protocol. ISRCRN86926298.

backgroundEach year in the UK approximately 367,000 people are diagnosed with cancer of whom half will experience moderate to severe chronic pain and a third are undertreated for their pain. Most people with cancer are cared for at oncology outpatient services where there are no standardised approaches for managing pain. As a result, cancer patients are at risk of receiving inadequate care for pain. There is a need for a standardised approach to pain management within oncology outpatient services. METHODS/

designThe aim of this pilot trial is to establish the feasibility of conducting a multi-centre clustered-randomised trial of an integrated standardised pain assessment and management programme integrated within routine care at oncology outpatient services in the United Kingdom National Health Service (NHS). We will conduct a two-arm pilot cluster randomised trial with nested process evaluation to evaluate the feasibility and acceptability of trial processes, establish fidelity of intervention implementation, estimate variability in outcomes and feasibility of future economic evaluation. Twelve outpatient services (clusters) from at least two NHS tertiary oncology referral centres (sites), in the North of England will be randomised (1:1) to deliver a pain management programme plus usual care or usual care alone and will recruit a total sample of 180 participants. Adults attending a participating outpatient service who self-report a score of ≥ 3 on the 0-10 Numerical Rating Scale (NRS) for worst pain in the past 72 h in any part of their body, and will be available for 1-week follow-up will be eligible. Participant self-reported questionnaires will be collected at baseline, 1-week, 1-month, and 2-months with medical record review at 1-month and 2-months. Progression to a future trial will be based on pre-defined criteria associated with eligibility and consent rates, follow-up and intervention delivery and acceptability. DISCUSSION: Little research has described optimal ways to implement a standardised pain assessment and management programme into oncology outpatient services. The strengths of the pilot trial are its sample size, number of clusters, and planned evaluation of trial processes and intervention fidelity to provide robust trial evidence to fully inform a future definitive phase III multi-centre cluster randomised trial within the UK NHS.

trial registrationThe CAPTURE pilot trial is registered on the ISRCTN registry (86,926,298).