ScarWork for post-breast surgery pain syndrome (PBSPS) in early-stage breast cancer patients: a protocol for a mixed methods feasibility study

Post-breast surgery pain syndrome (PBSPS) affects over 40% of BCa survivors and can persist for years after surgery, significantly impacting quality of life, including body image, daily functioning and mental health. Treatment options are limited. ScarWork, a light touch manual therapy for scars, may help reduce pain, but there are few studies evaluating its effectiveness in people with cancer. This study will employ a pragmatic, mixed-methods, randomised parallel-group exploratory design. Forty participants diagnosed with early-stage BCa who experience ongoing pain following surgery and/or radiotherapy will be randomly assigned to receive either up to five ScarWork sessions or a control group receiving usual care. The study will assess feasibility outcomes including recruitment, retention, and acceptability, as well as exploratory clinical outcomes related to pain, scar appearance and symptoms, physical function and psychosocial wellbeing. Quantitative outcomes will be measured using validated questionnaires at baseline, post-treatment, and four weeks post-treatment. Semi-structured interviews with participants and stakeholders will explore trial design, acceptability of the intervention and perceived effectiveness. Descriptive and exploratory statistical analysis will be used for quantitative data, and qualitative data will be analysed using the Framework method. This feasibility trial will provide evidence on the acceptability and feasibility of ScarWork for PBSPS within a National Health Service setting. Should the intervention prove both feasible and effective, a subsequent full scale, pragmatic randomised controlled trial will be conducted to further evaluate its impact. • Post breast surgery pain syndrome affects a large proportion of breast cancer survivors and can be difficult to manage. • This protocol describes a mixed methods feasibility study of ScarWork, a manual therapy targeting scar related pain. • The study is delivered in an National Health Service setting in the United Kingdom, and includes patient and stakeholder input to assess acceptability.