Title: A pilot study investigating the effect of post-operative home jejunostomy feeding on quality of life and nutritional parameters in patients with oesophago-gastric cancer
Funder: Department of Health (England)

Abstract: Background Cancer patients undergoing oesophagectomy/total gastrectomy are routinely fed while in hospital by a jejunostomy (small bowel) feeding tube. In-hospital studies have concluded that jejunostomy feeding (JEJ) reduces post-operative complications. No studies have assessed the potential benefits of giving JEJ feeding at home after discharge from hospital. This is despite evidence that patients frequently lose weight and struggle to meet their nutritional needs. The proposed pilot study will evaluate whether JEJ feeding at home improves quality of life and nutritional parameters, by comparing participants fed for 6 weeks with a control group receiving routine clinical care. A subset of participants will be interviewed to explore in depth the experience of home tube feeding. Aims The aim of the study is to pilot an investigation of the impact of 6 weeks of home JEJ feeding in patients undergoing oesophagectomy or total gastrectomy for cancer, with a view to submitting a funding application to undertake a definitive multi-centre randomised controlled trial. In particular we aim to estimate recruitment and retention rates; estimate variability in disease specific and general Quality of Life (QoL) measures; explore the relationship between disease specific and general QoL measures; explore the effect of home feeding on nutritional parameters and intake; estimate hospital readmission rates; explore patients' and their carers' experiences of home tube feeding; and to obtain estimates of healthcare costs. Plan of Investigation There will be two parts to the proposed pilot study. (A) A randomised controlled trial measuring quality of life, nutritional parameters and healthcare costs in 60 subjects undergoing oesophagectomy or total gastrectomy for cancer. Participants will be randomised to receive either 6 weeks of home JEJ feeding (intervention) or current practice (control). Data relating to quality of life, nutritional status and nutritional intake will be collected at 5 time points. (B) A qualitative exploratory study involving face to face semi-structured interviews with between 10 and 20 participants and their carers. These participants will be drawn from those assigned to the intervention group. Potential Impact This pilot study, an essential pre-cursor to a bid for a definitive multi-centre trial (potentially to HTA), will enable estimates of variability, effect size, recruitment and retention rates, treatment costs and acceptability to patients of home JEJ to be ascertained. By providing home feeding it is envisaged that more patient care would be delivered locally with a reduced need for hospital readmission for nutritional problems in the first months after surgery. This could represent cost-effective use of NHS resources. If demonstrated to be beneficial, the findings of a definitive trial would be applicable to the 1500-2000 patients undergoing oesophagectomy/total gastrectomy annually in the UK, potentially saving costs to the NHS and improving the post-operative patient experience.


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