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

Abstract

BackgroundCancers 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.MethodsA 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.DiscussionThe 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 registration27th January 2017 Australian and New Zealand Clinical Trial Registry (ACTRN12617000152325).

The Value of Preoperative Nutritional Status, the Systemic Inflammation Index and A Nomogram for the Prognosis of Patients with Esophageal Cancer After Radical Resection

“…Malnutrition further reduces the tolerance to treatment and ultimately affects recurrence and survival, leading to death [57,58] . In addition, malnutrition can affect the quality of life of patients with malignant tumors [59] . Therefore, strategies to improve the nutritional status of patients with malignant tumors are urgently needed.…”

“…Malnutrition further reduces the tolerance to treatment and ultimately affects recurrence and survival, leading to death [57,58] . In addition, malnutrition can affect the quality of life of patients with malignant tumors [59] . Therefore, strategies to improve the nutritional status of patients with malignant tumors are urgently needed.Increasing evidence shows that the interaction between cancer cells, the immune system and in ammation plays a crucial role in the occurrence and development of tumors [60] .…”

The roles of the dietitian in an 18-week telephone and mobile application nutrition intervention for upper gastrointestinal cancer: a qualitative analysis

“…In brief, The TEND study was a three-arm RCT exploring the impact of delivering an 18-week intensive nutrition intervention to patients newly diagnosed with UGI cancer (pancreatic, gastric and oesophageal cancer). The intervention was delivered by an experienced oncology dietitian, who provided personalised nutrition counselling and goal setting, with behaviour change strategies as informed by the Behaviour Change Technique Taxonomy (v1) [13][14][15]. A detailed representation of the dietetic intervention has been published [14].…”

“…The intervention was delivered by an experienced oncology dietitian, who provided personalised nutrition counselling and goal setting, with behaviour change strategies as informed by the Behaviour Change Technique Taxonomy (v1) [13][14][15]. A detailed representation of the dietetic intervention has been published [14]. Participants were allocated to receive the intervention using either the telephone or a mobile application, MyPace.…”

Prognostic Significance of Preoperative Prognostic Nutritional Index for Overall Survival and Postoperative Complications in Esophageal Cancer Patients

“…7,8 Besides, malnutrition can affect the quality of malignant patients' lives. 9 Thus, it is urgent to improve the nutrition status among malignant patients. Accumulating evidences suggest that the crosstalk between cancer cells and immune system and inflammation plays a crucial role in tumorigenesis and progression.…”