INDIGO randomised controlled digital clinical trial: INvestigating DIgital outcomes and quality of life in cancer survivors - a study protocol

Show simplified metadata
dc.contributor.affiliationImperial College Healthcare NHS Trust; Imperial College London; University Hospitals Birmingham NHS Foundation Trust; Macmillan Cancer Support; University of Leeds; Leeds Beckett University; NHS Race and Health Observatory; Cambridge University Hospitals NHS Foundation Trust; National Institute for Health and Care Excellence; Sweet Deal SL Barcelona; Guy’s & St Thomas’ NHS Foundation Trust; The Word Desk
dc.contributor.authorLe Calvez, Kerlann
dc.contributor.authorGregory, Jonathan J
dc.contributor.authorGath, Jacqui
dc.contributor.authorWheatstone, Pete
dc.contributor.authorAshley, Laura
dc.contributor.authorChinembiri, Owen
dc.contributor.authorCunliffe, Anthony
dc.contributor.authorDavenport, Garry
dc.contributor.authorJamieson Gilmore, Kendall
dc.contributor.authorLangel, Katri
dc.contributor.authorMiglio, Clara
dc.contributor.authorPakzad-Shahabi, Lillie
dc.contributor.authorPadmasri, Danush
dc.contributor.authorRuta, Danny
dc.contributor.authorWilliams, Helen
dc.contributor.authorWilliams, Matthew
dc.date.accessioned2025-10-09T14:51:54Z
dc.date.available2025-10-09T14:51:54Z
dc.date.issued2025-09-08
dc.description.abstractIntroduction: There are estimated to be 3.4 million patients in the UK living after a diagnosis of cancer. We know very little about their quality of life or healthcare usage. Patient-reported outcome measures (PROMs) are tools which help to translate a patient's quality of life into measurable categories, but how to do this at scale remains underexplored. The study employs a randomised design to assess different engagement strategies for optimising participation, data linkage and questionnaire completion in Northwest London and then nationally, with appropriate research approvals. Methods and analysis: We have designed and implemented an online, patient-completed, randomised observational trial. We will pilot it in Northwest London before national roll-out, using initially the General Practice (GP) record of a cancer diagnosis and then exploring the use of social media. The primary objective is to explore the feasibility of recruiting participants via self-identification or contact from the primary care research network and obtaining consent to link participants' PROMs responses to their cancer registry records. Data collection occurs through a secure platform, with participants directly responsible for data entry. There is no formal target sample size because this is a feasibility study, and we want to explore how many patients we can recruit. Analyses will be conducted using descriptive statistics, repeated measures multilevel modelling and machine learning techniques. If a substantial difference in responses between randomisation arms is detected, ineffective strategies will be removed. If no clear difference is observed, recruitment will continue with periodic reviews based on response rates and data completeness.
dc.identifier.citationLe Calvez K, Gregory JJ, Gath J, Wheatstone P, Ashley L, Chinembiri O, Cunliffe A, Davenport G, Jamieson Gilmore K, Langel K, Miglio C, Pakzad-Shahabi L, Padmasri D, Ruta D, Williams H, Williams M. INDIGO randomised controlled digital clinical trial: INvestigating DIgital outcomes and quality of life in cancer survivors - a study protocol. BMJ Open. 2025 Sep 8;15(9):e104336. doi: 10.1136/bmjopen-2025-104336.
dc.identifier.doi10.1136/bmjopen-2025-104336
dc.identifier.eissn2044-6055
dc.identifier.piibmjopen-2025-104336
dc.identifier.pmid40921632
dc.identifier.urihttps://westmid.openrepository.com/handle/20.500.14200/8559
dc.language.isoen
dc.publisherBMJ Publishing
dc.relation.urlhttps://bmjopen.bmj.com/
dc.rights© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
dc.source.beginpagee104336
dc.source.countryEngland
dc.source.issue9
dc.source.journaltitleBMJ Open
dc.source.volume15
dc.subjectMedical oncology
dc.subjectClinical protocols
dc.subjectQuality of life
dc.subjectRandomised controlled trial
dc.titleINDIGO randomised controlled digital clinical trial: INvestigating DIgital outcomes and quality of life in cancer survivors - a study protocol
dc.typeArticle
dspace.entity.typePublication
oa.grant.openaccessna
rioxxterms.versionNA
Files
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
1.7 KB
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
UHB Health Care Services