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Background: Cancers of the upper gastrointestinal tract commonly result in malnutrition, which increases morbidity and mortality. Current nutrition best practice lacks a mechanism to provide early and intensive nutrition support to these patients. A 3-arm parallel randomised controlled trial is testing the provision of a tailored, nutritional counselling intervention delivered using a synchronous, telephone-based approach or an asynchronous, mobile application-based approach to address this problem. This protocol outlines the design and methods that will be used to undertake an evaluation of the implementation process, which is imperative for successful replication and dissemination., Methods: A concurrent triangulation mixed methods comparative analysis will be undertaken. The nutrition intervention will be provided using best practice behaviour change techniques and communicated either via telephone or via mHealth. The implementation outcomes that will be measured are: fidelity to the nutrition intervention protocol and to the delivery approach; engagement; acceptability and contextual factors. Qualitative data from recorded telephone consultations and written messages will be analysed through a coding matrix against the behaviour change techniques outlined in the standard operating procedure, and also thematically to determine barriers and enablers. Negative binomial regression will be used to test for predictive relationships between intervention components with health-related quality of life and nutrition outcomes. Post-intervention interviews with participants and health professionals will be thematically analysed to determine the acceptability of delivery approaches. NVivo 11 Pro software will be used to code for thematic analysis. STATA version 15 will be used to perform quantitative analysis., Discussion: The findings of this process evaluation will provide evidence of the core active ingredients that enable the implementation of best practice nutrition intervention for people with upper gastrointestinal cancer. Elucidation of the causal pathways of successful implementation and the important relationship to contextual delivery are anticipated. With this information, a strategy for sustained implementation across broader settings will be developed which impact the quality of life and nutritional status of individuals with upper gastrointestinal cancer., Trial Registration: 27th January 2017 Australian and New Zealand Clinical Trial Registry ( ACTRN12617000152325 ).

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 ).