Title: Individualising breast cancer treatment to improve survival and minimise complications
Funder: Department of Health (England)

Abstract: AIMS AND OBJECTIVES To enhance quality and duration of breast cancer survivorship in a cost efficient manner. MAXIMISING SURVIVAL 1a) determine whether older women are being under treated for breast cancer once patient choice, tumour characteristics, health status and other confounder variables have been taken into account.. Choice will be measured by establishing and comparing surgeons’ perceptions of responsibility for the surgical decision with those of the patients. MINIMISING COMPLICATIONS 1b) undertake feasibility studies of whether pre-treatment health assessment protocol increases optimal management and reduces complications amongst elderly breast cancer patients; 2) compare arm swelling perometer measurements with multi-frequency bioimpedance in the prediction of chronic lymphoedema after axillary node clearance (ANC); 3) determine if early intervention in women developing arm swelling by 6 months post surgery prevents development of chronic lymphoedema. BACKGROUND Breast cancer is diagnosed in 44,000 and kills 12,000 women per year in UK. A disproportionate number of deaths (6,500) occur in women aged >70 years. Aggressive treatment improves survival, but increases the frequency of late complications. Older women are less likely to receive triple assessment and under-treatment of their breast cancer is common. Survival for older women is poorer in UK than in a number of comparable countries. Around 30% of patients are node positive and require ANC. Chronic lymphoedema is a distressing consequence of ANC in 40% of patients. Our focus is on optimising management for all women (regardless of age) while minimising the incidence and impact of common complications. RESEARCH PLANS Research is organised into 3 workstreams (WS). WS1 concentrates on optimising therapy. WS2 and WS3 concentrate on minimising or preventing complications after treatment. RESEARCH TEAM The team brings together senior NHS clinicians and researchers with a track record of innovation and delivery of health service research for patient benefit with experts in biostatistics, health economics, health related quality of life (HRQoL), NHS service management and includes patient representatives. We have published Department of Health (DH) funded randomised controlled trials (RCTs) which altered practice nationally. The team has over 1,000 peer reviewed publications with more than £30m of peer reviewed grants currently active. Bundred/Purushotham/Fallowfield are past or present members of the National Cancer Research Institute (NCRI) Breast Clinical Studies Group and are Chief Investigators in NCRI studies with peer reviewed research grants focussed on patient benefit. Todd is a current member of Primary Palliative Care NCRI subgroup. RESEARCH ENVIRONMENT The programme is based in a £12m breast centre at the University Hospital of South Manchester (UHSM) which treats over 700 new cancers annually and collaborates with several breast units to allow demonstration of general applicability of findings. Bundred is Clinical Lead for Research for the Greater Manchester and Cheshire Cancer Research Network (GMCCRN) and dissemination to the network will be through links with the National Cancer Research Network (NCRN) and NHS Breast Screening Programme. Manchester Cancer Studies and Nursing were both the top rated groups in the Research Assessment Exercise (RAE) 2008. Partners include the University of Manchester, Christie Hospital NHS Trust and Universities of Sussex, Liverpool and London will all contribute to the programme. Trusts in Oldham, Bournemouth, Poole, Derby, London and North Staffordshire will contribute patients to the programme. ANTICIPATED OUTPUTS WS1 – optimise treatment for elderly patients with breast cancer; WS2 – demonstrate whether diagnosis of lymphoedema with multi-frequency bioimpedance is more sensitive and specific than arm volume measurement in predicting chronic lymphoedema development after ANC; WS3 – prevent lymphoedema development after ANC by prophylactic external compression. This programme will develop follow up strategies which focus on prevention of morbidity following treatment based on individual risk and which are deliverable by a nurse. PUBLIC INVOLVEMENT Consumers have been intimately involved with the development of all workstreams since June 2007 and have reviewed/approved the projects. They have agreed to sit on a Steering Group to oversee the progress of the research. ETHICAL IMPLICATIONS All research involving patients and samples will be submitted for ethical approval and will not commence until approval has been received. Research governance requirements will be stringently adhered to. JUSTIFICATION FOR RESOURCES Resources have been requested for the sole aim of delivering the objectives of the programme in a timely way. Where possible the studies share resources and protocols and utilise research resources already available and are linked to pre-existing work to expedite set-up.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS