The effect of pain neuroscience education and behavioural graded activity among breast cancer survivors: A protocol for a randomised controlled trial.

Introduction: Chronic pain in breast cancer survivors (BCSs) impacts the health-related quality of life (HRQoL) and participation in activities of daily living tremendously[1-5]. Over the past decades, the use of pain neuroscience education (PNE) has been shown to be effective in reducing pain[6-8]. Since PNE alone has relatively small effect sizes, it should ideally be combined with a physical component[6], such as behavioural graded activity (BGA)[9,10]. Therefore, this study aims to investigate the effectiveness of PNE with BGA compared to usual care on chronic pain in BCSs. Methods: Two hundred BCSs with chronic pain will be randomly assigned to the intervention or usual care group. The intervention group will receive a 12-week treatment program consisting of 6 sessions, in which PNE and BGA are integrated. Whereas the usual care group will receive an information leaflet regarding "Pain in and after cancer". The primary outcome is pain, and the secondary outcomes are endogenous hyperalgesia and HRQoL. Explanatory variables such as pain cognitions, sleep, depression will be inventoried as well. All variables will be assessed at baseline, immediate, 3-and, 12-months post-treatment. To examine the added effect of PNE and BGA, a linear mixed model for repeated measurements will be conducted[11,12]. Results: We hypothesise that PNE with BGA will lead to more beneficial outcomes compared to usual care in BCSs with chronic pain. Discussion: PNE with BGA might lead to proper non-pharmacological treatment for pain in BCS. Process evaluation: Currently, 82/200 participants were recruited. The recruitment was delayed due to the COVID-19 outbreak. [ABSTRACT FROM AUTHOR]