INvestigating DIGital Outcomes in the Community

Cancer Clinical Trial

— INDIGO-Com  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06095024
• Other study ID #: 000000
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: Imperial College London
• Contact: Kerlann Le Calvez, MSc
• Phone: 0203 311 8427
• Email: kerlann.lecalvez[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The feasibility of developing a national longitudinal cohort	To assess what proportion of participants agree to ongoing, long-term follow-up	12 months
Primary	Completion of study questionnaire	Proportion of patients completing the entire study questionnaire	12 months
Primary	Agreement to link to national cancer data	Proportion of patients agreeing to link their data to national cancer data	12 months
Secondary	Completion of PROMs questionnaires	Proportion of patients completing PROMS questionnaires	12 months
Secondary	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
Secondary	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
Secondary	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