EMPOWER impact case study

Key features

• Dates: August 2013 - December 2016
• Recruitment figures: 38 patients
• Number of sites: 4
• Funder: NIHR Research for Patient Benefit Grant
• NIHR Clinical Research Network involvement: recruitment and participant support
• Chief Investigator: Dr Sandy Jack - Professor of Prehabilitation Medicine, University of Southampton and Consultant Clinician Scientist, Anaesthesia Critical Care and Perioperative Medicine Research Unit, University Hospital Southampton NHS Foundation Trust, NIHR Southampton Respiratory Biomedical Research Centre

Cancer prehabilitation is emerging as an effective health intervention for preparing patients to undergo cancer treatment. The EMPOWER study was designed to provide more data about how a responsive and personalised prehabilitation care plan can help to improve fitness levels and health outcomes for patients undergoing cancer treatment. The study investigated such improvements following a nine week structured responsive endurance training programme (SRETP) following neoadjuvant chemoradiotherapy but before rectal cancer surgery.

Adult patients with locally operable rectal cancer and who were yet to undergo any chemotherapy or radiotherapy were randomised into two groups to allow the research team to benchmark and compare the impact of participation: those selected to complete the nine week exercise programme, and those selected as part of the control group. To determine the participants’ exercise capacity and ensure they were medically safe to join the exercise programme, patients completed a cardiopulmonary exercise test (CPET) where heart rate was measured while undertaking an exercise session.

Patients attended clinical research facilities three times a week over a nine week period to complete the exercise programme on static exercise bikes, while having their heart rates monitored. Similar to High Intensity Interval Training (HIIT), participants cycled up and down hills, initially starting with 30 minute training sessions before progressing to 40 minute sessions after a period of two weeks. The trial achieved excellent participant adherence, with 94% of patients completing the nine week programme as directed.

The study was led by the University Hospital Southampton NHS Foundation Trust. NIHR Clinical Research Network (CRN) funded nurses and staff were involved in ensuring that there were no adverse events during the exercise sessions and provided support to a team of exercise science experts who led the training sessions. With CRN input, a total of 36 patients were recruited at University Hospital Southampton, Bournemouth Hospital and James Cook Hospital in Newcastle. The NIHR Research Design Service was instrumental in advising the study team and clarifying issues around feasibility. The research team worked closely with INVOLVE to improve patient participation.

Outcomes and findings

Throughout the exercise programme, CPET tests were completed at the three, six and nine week points, and the responsive exercise programme tailored for each participant accordingly. Following completion of the programme, quality of life improved in the exercise group and deteriorated in the control group. By training on a bike three times a week, the research team found that patients’ fitness returned to pre-treatment levels or improved within six weeks, but remained at post treatment levels or dropped for those who didn’t take part in the exercise programme (the control group).

The study outcomes demonstrate that the effectiveness of cancer treatment is affected by the patient’s physical fitness, with early data suggesting that tumour regression was improved in patients whose fitness was most improved.

Value to the NHS

The EMPOWER study has been instrumental in the commissioning of a new prehabilitation programme in Wessex, led and developed by experts at University Hospital Southampton NHS Foundation Trust. The new study, Wessex Fit-for-Surgery (WESFIT), is being trialled as part of NHS England’s Sustainability and Transformation Partnership (STP) for transforming cancer outcomes and survival. In partnership with the Wessex Cancer Alliance, Wessex Cancer Trust and council and community gyms, the study team received funding to look into whether or not the exercise sessions, along with psychological wellbeing support, can be taken out of hospital and delivered to more patients across the south.

The study will compare exercise sessions only, psychological support only or both together against current standard care for the level of effect on patients’ post-operative length of stay, quality of life, outcomes and one-year survival. It will use UK-first clinical measures of quality-of-life, developed by NHS England, which are designed to assess how well patients are living as opposed to focusing solely on clinical impact and how long patients live after treatment.

The main outcome of this study will be length of stay and the related analysis of resource usage will explore whether this intervention is cost-effective in improving outcome for these patients. If successful, it has the potential to achieve cost savings for the NHS in terms of delivering improved outcomes for patients undergoing cancer treatment. This research programme has also received funding support from the British Lung Foundation grant to fund a new study for palliative lung cancer patients.

Dr Sandy Jack - Chief Investigator; Professor of Prehabilitation Medicine, University of Southampton; Consultant Clinician Scientist, Anaesthesia Critical Care and Perioperative Medicine Research Unit, University Hospital Southampton NHS Foundation Trust, NIHR Southampton Respiratory Biomedical Research Centre:

“The NIHR and CRN were critical in supporting the EMPOWER trial and our other Fit-4-Surgery trials.

“This evidence has led to a funded Wessex based cancer prehabilitation study. The Wessex Fit-4-Cancer Surgery study (WesFit) is a region-wide introduction of such a clinical service in the guise of a randomised, controlled trial of clinical effectiveness.”