Title: Towards safer delivery and monitoring of cancer treatments. Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID).
Funder: Department of Health and Social Care

Abstract: Aims and Objectives eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) will develop and evaluate a system for patients to self-report adverse events (AE) during and after cancer treatments. It will be electronic, allowing AE-reporting from home/hospitals; integrated in routine care by documenting AE in existing Electronic-Patient-Records, generating alerts for severe AE and providing patient advice on mild AE. The overall aims are to improve the safe delivery of cancer treatments, enhance patient care/experiences and standardise documentation of AE within the clinical datasets. Background and rationale Over 250,000 patients in the UK are diagnosed with cancer each year. All cancer treatments have acute and long-term AE. An estimated 1.8 million people are living with and beyond cancer. Improving AE reporting/ documentation during and after cancer treatment can improve patient care through earlier detection/timely management of AE, directing patient to appropriate services for late-radiotherapy effects, supporting patients post-discharge after cancer surgery. However, a feasible, cost-effective and sustainable model is required. Information technology offers potential solutions for remote- monitoring, but there is a need for applied research to develop and evaluate such approach. Research plan We have a coherent and integrated programme of work that will develop and test the eRAPID intervention in: systemic treatment (chemotherapy and targeted therapies), radiotherapy for pelvic malignancies surgery for upper gastro-intestinal cancer The programme is organised in 5 work-packages (WP) applied across the clinical areas. Work-packages 1 to 3 comprise the development of eRAPID intervention. WP1 Electronic platform. Implement a secure flexible electronic platform for patients to report AE from clinic and home, with real-time AE documentation in Electronic-Patient-Records. WP2 Patients: AE items and advice. Develop patient-reported AE items, with defined severity grades and evidence-based patient advice and alerts. WP3 Professionals and care pathways. Understand and map the current patient pathways aiming to integrate eRAPID and identify key professionals to be trained in its delivery. On completion of the above, the eRAPID intervention model will be developed, ready for testing. WP4 Feasibility and pilot studies. Pilot eRAPID assessing patient /clinician feasibility and acceptability. WP5 Large Scale Evaluation: Undertake a randomised-controlled-trial to establish clinical and cost-effectiveness of eRAPID in Systemic-Treatment. Projected outputs We ll deliver a secure electronic platform suitable for online patient self-reporting, integrated with Electronic-Patient-Records that can support innovative models of patient-care in cancer and non-cancer settings. All clinical areas will deliver a tested eRAPID package for AE-monitoring and management during/after cancer treatments, based on online AE-reporting, with a tested self-management advice for mild/moderate symptoms and hospital-alerts for severe AE. In Systemic-Treatments our programme will provide evidence that allows commissioning and implementation of the eRAPID package (supported by a dissemination toolkit). In radiotherapy eRAPID we will fill-in the existing gap in collecting late-effects data, provide appropriate patient support and start building clinical-databases on radiotherapy late-effects. In upper-GI-surgery, we ll start building the evidence on whether it is feasible to use eRAPID in supporting patients post-surgery. Dissemination We will undertake structured consultations with key partners involved in the delivery and commissioning of cancer treatments. We will work closely with our Steering-Committee, National-Cancer-Action-Team, NHS commissioners and national clinical leads for cancer services to ensure our findings are transferable, inform policy and are implemented into the NHS. The research team and environment We bring together senior researchers, clinicians and patients with expertise and strong track records in cancer care, patient-centred research (development/validation of Patient-Reported-Outcome-Measures), health informatics, applications of IT for patient self-reporting, clinical trials methodology, health economics, qualitative methods and implementing interventions. Leeds, Bristol and Manchester offer an internationally recognised environment for conducting applied health-services and clinical research. We have received excellent support from clinical leads in the 3 centres, from the Yorkshire-Cancer-Research-Network and the West-Yorkshire-Comprehensive-Local-Research-Network. Patient and Public Involvement Three members of our team are patients, with further three supporting the Steering-Group. This has ensured that our plans have been developed with a strong Patient-and-Public-Involvement input, and the design of our intervention benefits from their ongoing contributions. We have an active patient Research-Advisory-Group in Leeds that meets formally twice a year and members contribute to ongoing projects. Management and Governance The Programme will be led by Prof Velikova, who successfully led the Programme-Development-Grant and has a track record of leadership at national and international level. Each clinical area and Work-package will have designated leads. A Programme-Management-Group will be formed, consisting of all co-applicants, with regular web-based conferences every 4-8 weeks. We have secured the support of leading experts to act as a Steering-Committee. For the randomised-controlled-trial we ll appoint a Data-Monitoring-and-Ethics-Committee. The main ethical issues relate to maintaining data security and patient confidentiality. We have a sophisticated data-management system to ensure patient data is obtained and stored securely and confidentially. Since 2009, we have a System-Level-Security-Policy, reviewed and approved annually by the Leeds-Teaching-Hospitals-NHS-Trust Caldicott Guardian, and the National-Information-Governance-Board.

Lay abstract: eRAPID stands for electronic patient self-Reporting of Adverse-events: Patient Information and aDvice. It is a clinical research programme aiming to develop and test an electronic system for cancer patients to report their symptoms online, which is integrated with their hospital records. With our Programme-Development-Grant we have successfully developed a robust, secure electronic reporting system (QTool) integrated with PPM (Patient-Pathway-Manager, the Leeds-Cancer-Centre Electronic-Patient-Records system). If a patient reports mild symptoms that do not require immediate medical intervention they receive individualised self-help advice online. When severe symptoms are reported an alert is triggered in PPM to the clinical team. The programme will develop eRAPID for systemic-treatment (chemotherapy), radiotherapy and after major surgery (oesophageal/gastric cancers). In pilot studies, we will test if eRAPID is acceptable to patients and staff. In Leeds, we will fully evaluate the system in a large study of 500 patients receiving systemic-treatment to explore if it provides better patient care and at what costs or savings to the NHS services and patients. To evaluate the system we will review clinical records to identify if the eRAPID system helps detect symptoms earlier and support self-management. We will explore the impact on patient quality-of-life through patient questionnaires and interviews and assess cost implications to both NHS and patients through a use of resources form, completed by patients. The programme is conducted in three cancer centres: Leeds, Manchester and Bristol. Professor Velikova leads the programme and the systemic-treatment evaluation. Work to develop and pilot test the system for surgical patients will be undertaken in Bristol, led by Professor Blazeby. The radiotherapy work will be done in Leeds and in Manchester, led by Dr Davidson and Dr Franks. The Leeds Research-Group is ideally placed to undertake and lead this programme of research. The Group has conducted patient-centred research with over 3,300 cancer patients, with many participants using touch-screen technology. The Group is based within the clinical setting of Leeds-Cancer-Centre, with close working relationships with clinicians who are hugely supportive of our research both in terms of advising, facilitating our studies and helping implement the research findings. Ethical considerations specific to eRAPID are data security and patient safety. We have developed a robust system to manage patient data securely and reliably and we have formal, approved safety monitoring processes to address any potential risks. Patients will benefit from eRAPID through more effective management of symptoms and improved quality-of-life. There is a potential cost-saving for the NHS through earlier detection/treatment of symptoms, preventing acute admissions. Wider patient and NHS benefits will result from implementing the system which can prospectively collect clinical and patient-reported data that informs NHS policy and development of future treatments and services.

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