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

Abstract

BackgroundA 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.MethodsThis 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.DiscussionThe 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 registration27th January 2017 Australian and New Zealand Clinical Trial Registry (ACTRN12617000152325).

Attitudes of Australian Patients Undergoing Treatment for Upper Gastrointestinal Cancers to Different Models of Nutrition Care Delivery: Qualitative Investigation

“…This qualitative study was set within a 3-arm RCT that examined two nutrition service delivery models, using a synchronous telephone-based approach or an asynchronous mobile app–based approach, to deliver a standardized early and intensive nutrition intervention to patients with UGI cancers (esophageal, gastric, and pancreatic) close to diagnosis, to determine improvements in quality of life, the protocol is available [ 13 ].…”

“…In many hospital-based health care settings, there is a lack of systems in place to provide the early and intensive nutritional support that is required by these high-risk cancer patients. Our research team conducted a 3-arm parallel randomized controlled trial (RCT) to test the provision of an early and intensive nutrition intervention to patients with UGI cancers using a synchronous telephone-based delivery approach versus an asynchronous mobile app–based approach delivered using an iPad compared with a control group to address this issue [ 13 ].…”

A process and mechanism of action evaluation of the effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer: a study protocol

“…This will be a concurrent triangulation mixed methods evaluation of a randomised controlled trial of two different service delivery models of dietetic interventions in patients with oesophagogastric and pancreatic cancer. Concurrent triangulation requires that data for qualitative and quantitative analyses be collected at multiple time points, with initial analyses of qualitative and quantitative data completed separately and then combined to compare the results for interpretation [ 28 , 33 , 34 ]. Data related to primary outcomes will be reported separately in the main trial paper.…”

“…We are currently undertaking a randomised controlled trial ‘Effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer’ [ 28 ]. This study is a prospective three-group intervention with a parallel economic evaluation.…”

“…Quality adjusted life years is the primary outcome and markers of nutritional status are secondary outcomes; all measured at baseline, three, six and 12-month time periods. The detailed protocol for the RCT has been described previously [ 28 ].…”