Effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer: study protocol of a randomised controlled trial.

BACKGROUND: A major challenge for those living with cancers of the upper gastrointestinal tract (oesophagus, stomach and pancreas), is the impact of the disease and treatment on nutritional status and quality of life. People with cancer and malnutrition have a greater risk of morbidity and mortality. Nutrition intervention is recommended to commence immediately in those who are malnourished or at risk of malnutrition. Novel cost-effective approaches that can deliver early, pre-hospital nutrition intervention before usual hospital dietetic service is commenced are needed. Linking clinicians and patients via mobile health (mHealth) and wireless technologies is a contemporary solution not yet tested for delivery of nutrition therapy to people with cancer. The aim of this study is to commence nutrition intervention earlier than usual care and evaluate the effects of using the telephone or mHealth for intervention delivery. It is hypothesised that participants allocated to receive the early and intensive pre-hospital dietetic service will have more quality-adjusted life years lived compared with control participants. This study will also demonstrate the feasibility and effectiveness of mHealth for the nutrition management of patients at home undergoing cancer treatment. METHODS: This study is a prospective three-group randomised controlled trial, with a concurrent economic evaluation. The 18 week intervention is provided in addition to usual care and is delivered by two different modes, via telephone (group 1) or via mHealth (group 2), The control group receives usual care alone (group 3). The intervention is an individually tailored, symptom-directed nutritional behavioural management program led by a dietitian. Participants will have at least fortnightly reviews. The primary outcome is quality adjusted life years lived and secondary outcomes include markers of nutritional status. Outcomes will be measured at three, six and 12 months follow up. DISCUSSION: The findings will provide evidence of a strategy to implement early and intensive nutrition intervention outside the hospital setting that can favourably impact on quality of life and nutritional status. This patient-centred approach is relevant to current health service provision and challenges the current reactive delivery model of care. TRIAL REGISTRATION: 27th January 2017 Australian and New Zealand Clinical Trial Registry ( ACTRN12617000152325 ).

Potential benefits of early nutritional intervention in adults with upper gastrointestinal cancer: a pilot randomised trial.

PURPOSE: This study aimed to test whether a very early nutrition intervention delivered over the telephone was feasible and could improve outcomes amongst patients with upper gastrointestinal cancer. METHODS: Participants with a histologically proven new diagnosis of primary oesophageal or stomach cancer and who were to undergo surgery and/or chemotherapy were randomised to receive either standard nutrition care (SC) or early and intensive nutrition intervention (NI) over the telephone/face-to-face. Participants were followed for 6 months. The primary outcome was quality of life (QoL), assessed using the European Organization for Research and Treatment of Cancer Global Quality of Life questionnaire C30 (EORTC QLQ-C30) and the European Quality of Life Instrument (EQ-5D) tool; secondary outcomes were nutritional status and survival. RESULTS: Twenty-one participants were recruited (11 SC and 10 NI). At baseline, the prevalence of malnutrition was 90 %. Compared with SC, the NI group had a significantly higher EORTC global QoL score at the first mid-study follow-up (coefficient (95 % CI) 21.0 (12.1, 29.9) adjusted for baseline, p < 0.001) and at 26 weeks (28.4 (21.3, 35.4) adjusted for baseline, p < 0.001). Nutritional risk score was lower (p < 0.001), and loss of body weight attenuated (p < 0.001) in the NI group compared with SC. Six deaths occurred during the study, five in the SC group and one in the NI group (p = 0.06). The mean time spent with a dietitian per contact was significantly less for the NI group compared with SC (16(3) vs 40(6) min per dietetic contact, p < 0.001). CONCLUSIONS: This pilot study has shown the potential of a novel telephone-based early and intensive dietetic model of care for newly diagnosed upper gastrointestinal cancer patients.