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Currently submitted to: Journal of Medical Internet Research

Date Submitted: Apr 20, 2026

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Investigating Digital Outcomes (Indigo) A Randomised Observational Digital Trial: Results of Pilot Study

  • Kerlann Le Calvez; 
  • Matthew Hardy Williams; 
  • Jonathan J. Gregory; 
  • Radvile Mauricaite; 
  • Gregory Mickiewicz; 
  • Jacqui Gath; 
  • Pete Wheatstone; 
  • Lillie Pakzad-Shahabi; 
  • Laura Ashley; 
  • Owen Chinembiri; 
  • Anthony Cunliffe; 
  • Garry Davenport; 
  • Kendall Jamieson Gilmore; 
  • Katri Langel; 
  • Clara Miglio; 
  • Danush Padmasri; 
  • Danny Ruta; 
  • Helen Williams

ABSTRACT

Background:

There are more than 3M people in the UK living with a diagnosis of cancer. These are a varied group of people, ranging from those who had curative surgery 20 years ago to those who have exhausted all options and are under palliative care. However, the prevalent population is much larger than the incident population, and is under-researched, and we know very little about their healthcare utilisation or quality of life. In addition, there are open methodological questions about which questionnaires are best to use and how best to ask people for this information.

Objective:

To assess the feasibility of implementing, measuring and assessing the impact of timing on completion of questions about data linkage and the performance of different approaches to collecting quality of life and healthcare utilisation data in cancer survivors in a scalable robust manner via a pilot clinical trial.

Methods:

We designed and implemented an online randomised observational clinical study using an electronic survey platform. We provided trial information and obtained informed consent from all participants online and used randomisation to assess the acceptability of different quality of life tool and to assess the impact of timing on completion of questions about data linkage. We piloted the study in Northwest London and compared our trial population to the underlying patient population from the WSIC dataset.

Results:

135/345 GP practices in NWL participated, and sent SMS messages to 25044 people, of whom 2518 accessed the survey (9%); in addition, 761 accessed the survey via email and a further 15 participants via social media. 1600 provided informed consent and completed the EQ-5D-5L questionnaire and these formed our analytical cohort. The median age of participants was 68 years; 46% were female, 72% heterosexual. 15% from an ethnic minority. The commonest tumour sites were breast, prostate and colorectal cancer (respectively 35%, 15% and 11%). 67% of participants had been diagnosed more than 5 years ago. 90% described themselves as cured. 46% had accessed healthcare services in the last 12 months. Of those working, 33% had reduced their hours because of their diagnosis. 22% were disabled and 33% reported that the standard QoL questionnaires did not cover their cancer-related symptoms and participant rating of additional QoL questionnaires was broadly similar. 74% agreed to linkage with national cancer data.

Conclusions:

The implementation, and delivery of an online observational trial are feasible and enable us to recruit a prevalent cancer population, 2/3rds of whom had been diagnosed > 5 years ago. Most participants are happy to allow linkage to national cancer data. We used this pilot phase to refine some of search criteria, and the trial is currently recruiting nationally. Clinical Trial: NCT06095024: Investigating Digital Outcomes for Cancer Survivors in the Community.


 Citation

Please cite as:

Le Calvez K, Williams MH, Gregory JJ, Mauricaite R, Mickiewicz G, Gath J, Wheatstone P, Pakzad-Shahabi L, Ashley L, Chinembiri O, Cunliffe A, Davenport G, Jamieson Gilmore K, Langel K, Miglio C, Padmasri D, Ruta D, Williams H

Investigating Digital Outcomes (Indigo) A Randomised Observational Digital Trial: Results of Pilot Study

JMIR Preprints. 20/04/2026:95151

DOI: 10.2196/preprints.95151

URL: https://preprints.jmir.org/preprint/95151

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