iCare – a self-directed, interactive online program to improve health and wellbeing for people living with upper gastrointestinal or hepato-pancreato-biliary cancers, and their informal carers: the study protocol for a Phase II randomised controlled trial
Authors: Livingston Patricia M , Winter Natalie , Ugalde Anna , Orellana Liliana , Mikocka-Walus Antonina , Jefford Michael , Zalcberg John , Orford Neil , Hutchinson Alison M , Barbour Andrew , Kiss Nicole , Smithers Bernard Mark , Watson David I , McCaffrey Nikki , White Victoria ,   the iCare Advisory Group, Mouzakis Kon , Mihalopoulos Catherine , Lane Katherine , Austin David W. , O Eric , Whitfield Kathryn , Menzies David , Larsen Amy , Swiatek Dayna , Yuen Eva , Greenhill Elysia , Russell Lahiru , Stevenson Keon , Musat Toni 
Published: January 2024

Abstract
Background
Up to 70% of people diagnosed with upper gastrointestinal (GI) tract or hepato-pancreato-biliary (HPB) cancers experience substantial reductions in quality of life (QoL), including high distress levels, pain, fatigue, sleep disturbances, weight loss and difficulty swallowing. With few advocacy groups and support systems for adults with upper GI or HPB cancers (i.e. pancreas, liver, stomach, bile duct and oesophageal) and their carers, online supportive care programs may represent an alternate cost-effective mechanism to support this patient group and carers. iCare is a self-directed, interactive, online program that provides information, resources, and psychological packages to patients and their carers from the treatment phase of their condition. The inception and development of iCare has been driven by consumers, advocacy groups, government and health professionals. The aims of this study are to determine the feasibility and acceptability of iCare, examine preliminary efficacy on health-related QoL and carer burden at 3- and 6-months post enrolment, and the potential cost-effectiveness of iCare, from health and societal perspectives, for both patients and carers.

Methods and analysis
A Phase II randomised controlled trial. Overall, 162 people with newly diagnosed upper GI or HPB cancers and 162 carers will be recruited via the Upper GI Cancer Registry, online advertisements, or hospital clinics. Patients and carers will be randomly allocated (1:1) to the iCare program or usual care. Participant assessments will be at enrolment, 3- and 6-months later. The primary outcomes are i) feasibility, measured by eligibility, recruitment, response and attrition rates, and ii) acceptability, measured by engagement with iCare (frequency of logins, time spent using iCare, and use of features over the intervention period). Secondary outcomes are patient changes in QoL and unmet needs, and carer burden, unmet needs and QoL. Linear mixed models will be fitted to obtain preliminary estimates of efficacy and variability for secondary outcomes. The economic analysis will include a cost-consequences analysis where all outcomes will be compared with costs.

Discussion
iCare provides a potential model of supportive care to improve QoL, unmet needs and burden of disease among people living with upper GI or HPB cancers and their carers.

Australian and New Zealand Clinical Trials Registry
ACTRN12623001185651. This protocol reflects Version #1 26 April 2023.