Testing the operability and transferability of a feasibility tested web-based intervention to support pain and self-management following surgery for breast cancer: the ePainQ pilot RCT

Research question Can we transfer usability and operatability of a web-based intervention across different NHS IT systems and provide support and improve self-management and outcomes for patients undergoing surgery for breast cancer? Background Breast cancer affects 55,000 women every year in the UK.

Most will have surgery (90%), either mastectomy (whole breast removal), or breast conserving surgery (removal of the cancer with an area of healthy tissue) with or without axillary surgery.

Pain is frequently experienced after surgery (50%), including day surgery, with patients having to self-manage symptoms at home. Poorly managed acute pain can develop into long-term pain and impact physical and mental well-being. Evidence suggests better symptom management after surgery reduces the number having long-term issues.

Our work highlighted a lack of information and confidence to prioritise self-management and lack of awareness that poorly managed acute pain can cause long-term pain. We co-developed a web-based intervention with patients and healthcare professionals to provide additional support. This was feasibility tested at large hospital with patients finding it acceptable, usable and supportive.

Aims and Objectives The overall aim is to test the intervention in other NHS Trusts to understand how it works across different IT systems, and evaluate if it can be fully evaluated to support self-management with the aim of reducing acute and long-term symptoms in a phase III multi-centre RCT.

Methods Six work-packages (WP) will achieve the following specific objectives: WP1 - development work with site IT departments/collaborators to understand and address IT variations across NHS Trusts and how to allow integration of the intervention.

WP2 - in conjunction with key stakeholders (surgeons/oncologists/specialist nurses/hospital managers/commissioners/charity representatives), update the intervention to include clinical advances since development and address potential advice variations across sites. WP3 - explore recruitment options in the post-covid setting.

WP4 - explore acceptability of the intervention across sites and refine it for full-scale evaluation in a multi-site RCT; implementation informed by an evaluability assessment. WP5 - determine costs of any variations identified in WP1 and model the cost-consequences.

WP6 - develop the evaluative phase III RCT Timelines for delivery WP1: M1-8 – development/approvals WP2: M2-8 – intervention refinement and testing WP3: M3-6 protocol options/development WP4: M3-9 protocol/approvals; M10-24– site set-ups and recruitment; intervention delivery; M24-33 - evaluability assessment; M18-30 data analysis WP5: M24-34 cost analysis WP6: M24-36 Anticipated Impact and Dissemination This work will allow for insight into reasons for and current variations in IT systems across the NHS and interaction between data collection systems e.g. patient reported outcome measures (PROMs) and electronic patient records (EPRs).

It will contribute to the development of a phase III RCT to test the intervention for effectiveness. This understanding will help to address potential barriers to patients self-reporting symptoms post-surgery.

We will work with professional associations, patients and charities to promote and share the study findings and intervention including presenting at national/international meetings and publish in peer reviewed journals.

We will work with our PPIE co-applicant and group to co-create all information materials to share with patients and the public.