Evidence map›Paper›PMID 38287317›Full record

ArticleBMC cancer2024

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, Natalie Winter, Anna Ugalde, Liliana Orellana, Antonina Mikocka-Walus, Michael Jefford, John Zalcberg, Neil Orford, Alison M Hutchinson, Andrew Barbour and 6 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.5field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 3 countries.

Patricia M LivingstonDeakin University, Geelong, VIC, 3220, Australia. trish.livingston@deakin.edu.au.
Natalie WinterDeakin University, Geelong, VIC, 3220, Australia.
Anna UgaldeDeakin University, Geelong, VIC, 3220, Australia.
Liliana OrellanaBiostatistics Unit, Faculty of Health, Deakin University, Geelong, VIC, Australia.
Antonina Mikocka-WalusSchool of Psychology, Faculty of Health, Deakin University, Geelong, VIC, Australia.
Michael JeffordDepartment of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
John ZalcbergDepartment of Medical Oncology, Alfred Health and School of Public Health, Faculty of Medicine, Monash University, Melbourne, Australia.
Neil OrfordMonash University, Melbourne, Australia.
Alison M HutchinsonDeakin University, Geelong, VIC, 3220, Australia.
Andrew BarbourUpper GI Unit, Princess Alexandra Hospital, Faculty of Medicine, University of Queensland, Brisbane, Australia.
Nicole KissInstitute for Physical Activity & Nutrition, Faculty of Health, Deakin University, Geelong, VIC, Australia.
Bernard Mark SmithersUpper GI Unit, Princess Alexandra Hospital, Faculty of Medicine, University of Queensland, Brisbane, Australia.
David I WatsonDiscipline of Surgery, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
Nikki McCaffreyDeakin Health Economics, School of Health and Social Development, Faculty of Health, Deakin University, Geelong, VIC, Australia.
Victoria WhiteSchool of Psychology, Faculty of Health, Deakin University, Geelong, VIC, Australia.
iCare Advisory Group
Deakin University · AUBarwon Health · AUFlinders University · AUThe University of Queensland · AUAlfred Health · AUThe University of Melbourne · AU

Funding

Medical Research Future Fund 2022128
6 · The paper itself

Abstract

backgroundUp 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.

Indexed as

NeoplasmsUpper Gastrointestinal TractAdultAustraliaCaregiversClinical Trials, Phase II as TopicHumansQuality of LifeRandomized Controlled Trials as TopicBile ductEconomics of cancerLiverOesophagusOnlinePancreasPhase II randomised controlled trialStomachSupportive careUpper GI cancersWeb-based platforms

Identifiers

PMID38287317
PMCPMC10826031
OpenAlexW4391315919

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.