INvestigating DIGital Outcomes in the Community

NCT06095024 | Unknown

• 1 other identifier: 000000
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the feasibility and best methodology for collecting patient-reported outcome measures in patients who have previously been treated for cancer and are living in the community. The investigators are working with primary care research teams, and using an online electronic questionnaire. Although the study is entirely observational, the study offers some of the questions in a random order, so the investigators can explore the effect of changing the way in which questions are asked.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• Completion of study questionnaire

  Proportion of patients completing the entire study questionnaire

  12 months

• Agreement to link to national cancer data

  Proportion of patients agreeing to link their data to national cancer data

  12 months

Secondary Outcomes (4)

• Completion of PROMs questionnaires

  12 months

• Satisfaction with questionnaires

  12 months

• Effectiveness of different communication channels for recruitment

  12 months

• Correlation of each PROM score with quality of life

  12 months

Other Outcomes (1)

• The feasibility of developing a national longitudinal cohort

  12 months

Study Arms (4)

Linked to national data

Patients will be randomly assigned to be asked to link personal data with national cancer data. The outcome measure will be the proportion of completed questionnaires

Linking to national data, early vs. late questions

Subset of cohort 1: Patients will be randomly assigned to be asked the question about data linkage at the beginning vs. end of the questionnaire The outcome measure will be the proportion answering yes in each arm

Different PROM Completion rate

Patients will be randomised to two different PROM questionnaires The outcome measure will be the completion rate of the two different questionnaires

Impact of additional PROMS on completion and satisfaction

Patients will be randomised to either a standard PROM or additional, symptom directed questionnaire The outcome measure will be the satisfaction rate of patients in each arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults living with a previous diagnosis of cancer in a defined geographical area (NW London in stage 1; nationally in stage 2)

You may qualify if:

• Participants who self-identify as having previously (time unlimited) received a diagnosis of cancer, based on histological, radiological, or clinical grounds (primary and/or metastatic cancer). Current treatment is not a barrier to participation, but the emphasis is on patients who have completed treatment.
• Participants need to be able to access the secure online platform, using a mobile device or computer.
• Have capacity and be able to provide informed consent via the online platform.
• To be able to understand, read and write English, with or without support from a trusted individual e.g., friends, family, carer.

You may not qualify if:

• Participants recently diagnosed with cancer (less than 12 months ago).
• Participants unable to access secure online platform.
• Participants who do not have sufficiently good understanding of written English to complete the PROMs and are unable to be supported by a trusted individual to complete the questionnaire.
• Participants lacking capacity and unable to give informed consent.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

Location

Related Publications (1)

• Le 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.

  PMID: 40921632 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Matthew Williams, MBChB PhD FRCR

  Imperial College Healthcare Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerlann Le Calvez, MSc

CONTACT

0203 311 8427; kerlann.lecalvez@nhs.net

Matthew Williams, MBChB PhD

CONTACT

matthew.williams@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 23, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)