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

Sep 22, 2026

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iCare is a self-directed, interactive online program designed for people living with upper gastrointestinal or hepato-pancreato-biliary cancers and their informal carers. The study addresses substantial quality-of-life reductions seen in up to 70% of patients, including distress, pain, fatigue, sleep disturbance, weight loss, and swallowing difficulties. A Phase II randomized controlled trial recruits 162 patients and 162 carers to compare iCare with usual care. Feasibility and acceptability are assessed at baseline and 3 and 6 months, alongside effects on QoL and carer burden and potential cost-effectiveness from health and societal perspectives.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Abstract

Background

Methods and analysis

Discussion

Keywords

Livingston etal. BMC Cancer (2024) 24:144 [https://doi.org/10.1186/s12885-024-11861-2](https://doi.org/10.1186/s12885-024-11861-2) BMC Cancer STUDY PROTOCOL Open Access 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 Patricia M Livingston 1,2,3*, Natalie Winter1,2,3, Anna Ugalde 1,2,3, Liliana Orellana4, Antonina Mikocka‑Walus5, Michael Jefford6,7, John Zalcberg8, Neil Orford9,10,11, Alison M Hutchinson 1,3,10, Andrew Barbour12, Nicole Kiss 13, Bernard Mark Smithers12, David I Watson 14, Nikki McCaffrey15, Victoria White5 and the iCare Advisory Group 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 sup‑ portive 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 ofthis 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, recruit‑ ment, 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 *Correspondence: Patricia M Livingston [trish.livingston@deakin.edu.au](trish.livingston@deakin.edu.au) Full list of author information is available at the end of the article © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ()[. The Creative Commons Public Domain Dedicat

FAQs

What problem does the iCare program target for patients and informal carers?

It targets major quality-of-life reductions associated with upper gastrointestinal or hepato-pancreato-biliary cancers, including distress, pain, fatigue, sleep disturbances, weight loss, and swallowing difficulties, alongside supportive needs of informal carers.

How will participants be assigned in the Phase II trial?

162 newly diagnosed patients and 162 carers will be recruited and randomly allocated 1:1 to either the iCare program or usual care, with assessments at enrolment, 3 months, and 6 months.

What are the primary and secondary outcomes of the trial?

Primary outcomes are feasibility (eligibility, recruitment, response, and attrition) and acceptability (engagement with iCare such as login frequency and time, plus feature use). Secondary outcomes include changes in patient QoL and unmet needs and carer burden, unmet needs, and QoL.

Sep 22, 2026

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