INvestigating DIGital Outcomes in the Community (INDIGO-Com)

INDIGO Community Participant Led Electronic Completion of PROMs and PREMs for Patients Living With and Beyond Cancer in the Community

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer

Detailed Description

INDIGO Community aims to both collect data on patient-reported outcome measures (PROMS) and patient-reported experience measures (PREMS) and data on the impact of how to do this.

The focus is on adult patients living in the community who have previously been treated for cancer.

The study uses a range of quality of life questionnaires, and randomises the order in which some questions are asked, in order to explore the impact of how questions are asked on responses.

All patients with be offered the EuroQol 5 dimension, 5 level questionnaire (EQ5D-5L)

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Kerlann Le Calvez, MSc; Phone Number: 0203 311 8427; Email: kerlann.lecalvez@nhs.net
• Study Contact Backup: Name: Matthew Williams, MBChB PhD; Email: matthew.williams@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W6 8RF
    • Imperial College Healthcare NHS Trust
    • Contact: Matthew Williams, MBChB PhD; Email: matthew.williams@imperial.ac.uk
    • Contact: Kerlann Le Calvez, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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)

Description

Inclusion Criteria:

• Anyone over the age of 16 who has been diagnosed (receiving treatment is not an inclusion criteria although the investigators expect as this is a long-term survivorship study all participants will have received treatment) for any type of cancer in the past (> 12 months) can participate.
• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of PROMs questionnaires	Proportion of patients completing PROMS questionnaires	12 months
Satisfaction with questionnaires	Patient-reported satisfaction with questionnaires, expressed as average scores (on a scale of 1 - 10, where 10 is better) and proportion scoring 5 or over	12 months
Effectiveness of different communication channels for recruitment	Enrolment rate via different recruitment channels (Primary Care Research Network, Social Media) expressed as the proportion of patient recruited via each channel	12 months
Correlation of each PROM score with quality of life	Correlation of each PROM score with the EuroQol 5 Dimensions, 5 levels (EQ5D-5L) quality of life measure	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility of developing a national longitudinal cohort	To assess what proportion of participants agree to ongoing, long-term follow-up	12 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Imperial College Healthcare NHS Trust
• Investigators: Principal Investigator: Matthew Williams, MBChB PhD FRCR, Imperial College Healthcare Trust

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 000000 (MRDC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared, where patients give permission, with the national cancer registration service. Future researchers may then access the data via that route.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No