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Table 3 Process evaluation objectives, questions and collection of data

From: 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

Domain Questions Data source Data Analysis Technique
1). Content  • What are the number of instructions provided by the dietitian per participants?  • What are the content areas of instructions/goals provided by the research dietitian to participants? To measure and compare:  • Classification of the research dietitian directed goals (where the dietitian has directed the focus, dose, frequency and timing of the goal)  • Classifications of the collaboratively set goals (where the participant has decided upon either the focus, dose, frequency or timing of the goal)  • Classifications of the nutrition impact symptoms reported by the participant to the research dietitian  • Classifications of the behaviour change techniques used by the research dietitian to support achievement of the goal  • Classification of the written nutrition education materials provided by the research dietitian to the participant Audio recordings, MyPace messages and emails, paper based initial nutrition assessment and review forms Content analysis using a classification matrix
2). Dose/Contact To measure and compare:  • Time from baseline assessment completion until research dietitian attempt to contact the participant to commence intervention  • Time from baseline assessment completion until first successful contact between research dietitian and participant  • The methods used by participants to initiate contact with dietitian  • The frequency of contact between research dietitian and participants  • The proportion of participants who had at least one contact with the research dietitian every 2 weeks for the duration of the 18-week intervention period  • The proportion of participants who were sent written nutrition education materials  • The proportion of participants who were sent a trial pack of oral nutrition support products  • The proportion of participants who have family member/carer involvement in intervention interactions Audio recordings, MyPace messages and emails, paper based initial nutrition assessment and review forms, MyPace analytics, post intervention semi-structured interviews Descriptive statistics, Cox proportional hazards regression analysis, either Poisson or negative binomial regression (depending on the data distribution), logistic regression
3). Behaviour change  • To measure and compare the number of behaviour change goals achieved per participant between groups. Audio recordings, MyPace messages and emails, paper based initial nutrition assessment and review forms Poisson or negative binomial regression (based on the data distribution), sensitivity analysis
4). Barriers and facilitators to engagement  • Identify, describe and contrast the types of barriers and facilitators to engagement of participants between the intervention groups Audio recordings, MyPace messages and emails, research dietitian field notes, semi-structured post intervention participant interviews Thematic analysis
5). Acceptability  • The acceptability of the intervention from the perspective of participants and research dietitian and treating team including Surgeons, Oncologists/Radiation Oncologists, hospital-based dietitians) Semi-structured post study health professional interviews Thematic analysis
6). Factors mediating engagement, behaviour change and health outcomes  • What are the inter-relationships between a range of demographic, process, behaviour change and health outcome measures to better understand the potential mechanisms of action of the interventions delivered?  • What are the relationships between participant demographics and measures of engagement. Baseline demographic and technology confidence data, weight and HRQoL data at baseline and 6 months, data on survival at 6 months, intervention delivery records, research dietitian field notes, semi-structured post intervention participant interviews Poisson or negative binomial regression (dependent on the data distribution), multiple logistic regression, multiple regression analysis and multiple Cox proportional hazards analysis
  1. *Adapted from [32, 56, 57]