Title: The development and feasibility testing of electronic patient self-reporting and delivery of an internet based patient educational package to reduce the impact of persistent pain and improve quality of life following breast cancer surgery
Funder: Health Education England

Abstract: Title: The development and feasibility testing of electronic patient self-reporting and delivery of an internet based patient educational package to reduce the impact of persistent pain and improve quality of life following breast cancer surgery. Background: Chronic post-surgical pain is a recognised issue of breast cancer survivorship. Breast cancer is the most common cancer affecting women with over 44,000 diagnosed each year in the UK (UK Office for National Statistics). The needs of survivors are increasingly being recognised (Ganz 2008, 2011, Hopwood 2010). More than 25% of cancer patients have long term treatment related side effects (Richards et al 2011). Disease free survival has increased significantly in the last 20 years. Traditional follow up is changing, with less emphasis on clinical follow up and more on imaging and self-management packages. This is in line with the Cancer Reform Strategy (2007, 2009). Patients can self-report concerns and this could be improved, costing less by using follow-up regimes including questionnaires and Internet access (Lu 2011, 2012). It is possible to link computer tracking with electronic patient records and primary care enabling data to be recorded (Ashley 2011). An unintended consequence of same day discharge following surgery is that active post-operative pain management can be missed. The transition of acute post-operative pain to chronic post-surgical pain is complex, but it appears that severe acute pain contributes to developing chronic pain (Moka et al 2013). Monitoring the acute and long term pain management is, therefore, a high priority (Harrington et al 2010; Ganz 2011; Richards et al 2011) Aim of the work: To develop and evaluate the feasibility of breast cancer patients undergoing surgery, self-reporting adverse events (AEs), including pain and quality of life using a remote electronic system. The system will provide a tailored pain education package based on patients self-reporting. The aim is to improve the delivery of patient education resulting in better self-management and encourage patients to actively manage acute postoperative pain, which may reduce the incidence of chronic post-surgical pain. Deliverables: A feasibility tested electronic patient reported, pain self-management system and educational package ready to be evaluated for potential adoption in the NHS. Plan of Investigation: The plan follows the MRC framework for developing complex interventions. The purpose is to conduct a proof of concept feasibility of on-line self-reporting, patient self-management advice and supportive educational intervention. Phase 1: Scoping review of persistent surgical pain Phase 2: Systematic review of resources for patient feedback and education Phase 3: Intervention Development and selection of the outcome measures. The Intervention will be developed with focus groups involving patients, clinicians and stakeholders to identify the appropriate content and outcome measures. The screening tools will be selected and administered to a group of patients chosen by purposive sampling. Patients will be asked for their feedback via a debriefing survey. Phase 4: Feasibility study to test the feasibility of prospectively monitoring pain and quality of life at baseline, post-surgery, 4 months and 1 year and providing a real time educational self-management package for patients diagnosed with early breast cancer. Primary outcomes: pain control, patient acceptance of electronic resources as a method of patient education and cost effectiveness. Phase 5: Qualitative Interviews for feedback on the PROMs and package including acceptance rates. The PPI component will evaluate the adequacy of the current information offered. Potential benefit to patients and the NHS: Benefits for patients include better self-management, early detection of those in need of further support and reduced incidence of persistent post-surgical pain. Benefits for the NHS include better documentation of AEs, improved patient management and reduced costs from hospital contacts and on-going need for pain management.

Lay abstract: Breast Cancer is one of the most common cancers in the UK, with around 45,000 new cases diagnosed every year. It is well documented that cancer survivors often experience late effects post treatment and on-going psychosocial problems due to these. The Government's Cancer Reform Strategy (2009) recommends that patients be supported in self-management and have personalised follow-up to meet their needs. Persistent post-surgical pain is recognised as a major issue of breast cancer survivorship. Post-operatively, patients are regularly asked about their pain and given analgesia as requested. Analgesia is often prescribed as required (PRN) with the emphasis on the patient requesting it rather than it been given regularly. Patients often have local anaesthetic given in theatre, so pain in the hours whilst an in-patient is reduced. There are no specific methods routinely used for monitoring pain once patients are discharged, which in the majority of cases is the same day as surgery. The advent of 24 hour/daycase surgery means patients have little time post-surgery to discuss any worries with ward staff. Staff are under pressure to deliver care in tight timescales and issues such as chronic pain are not considered a priority. Most of what we know about the side effects of breast cancer treatments has been collected from follow-up clinical appointments. Traditional follow-up is changing, with less emphasis put on clinical follow-up and more on imaging and self-management packages. Clinical follow-up is often minimal after completion of radiotherapy, and it is not uncommon for patients to be discharged from hospital follow-up one year after their initial surgery. With long gaps in-between follow-up and the increasing practice of early discharge, breast cancer patients can go long periods without the direct opportunity to discuss quality of life issues such as persistent pain and treatment related side effects. This will only increase with the rise in numbers of patients discharged early. Educational packages are written and not always verbalised with patients on discharge. Patients admit to not always reading the information, this number increasing if the information is not discussed with them or pointed out as important. Early intervention, advice or a different method of information delivery could prevent pain from becoming a chronic problem. Overall Doctoral Aim: To investigate if information collected by novel electronic methods can improve patient education and reduce the number of patients who develop acute and chronic post-surgical pain following surgery for breast cancer. The project includes a review of research already published on persistent post-surgical pain and a more detailed systematic review of patient electronic educational packages. Focus groups of patients, clinicians and stakeholders will be conducted to identify the best methods for collecting information and to assist with developing the interventional package, including analgesic advice. A feasibility study will help to test the intervention including uptake rates. Patient and staff qualitative interviews will gain feedback on the intervention. This project will take advantage of electronic resources already developed for the collection of patient feedback that has proven popular with patients, providing timely feedback and advice. Care will be taken to ensure the feasibility study is acceptable and simple to run. The systematic review will help inform any changes required in the design of the feasibility study. Feasibility study: All patients with breast cancer will be given clear and concise information regarding the study and be allowed to consider if they wish to participate or not. They will be asked to complete data collection via novel electronic resources. They will then receive advice on pain and post-operative management based on the answers they have given. Those declining or with no internet access will be asked to participate using traditional pen and paper questionnaires. Using an electronic system to complete patient reported outcome measures aims to maximise convenience and reduce costs (staff, data entry, postage etc.). Automated feedback to research/clinical staff will alert them to patients who indicate on their questionnaires that they may require further support. Collecting this information will allow us to put extra support in place and plan more individualised care pathways. The progress of the feasibility study will be monitored and will have ethics approval. The chosen team are best placed to carry out the research and provide essential experience in the treatment and management of breast cancer, pain management and qualitative methods and have delivered on many previous trials. The team contains experts from the multidisciplinary team, including surgeons, research nurse, radiology, oncology/psycho-oncology, quality of life, data analysis, qualitative research and pain. This will allow results to be widely disseminated and implemented.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;6.4 SURGERY
Health categories: CANCER AND NEOPLASMS