INvestigating DIGital Outcomes in the Community (INDIGO-Com)

Imperial College London

Status: Not yet enrolling

Conditions: Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06095024

000000

Details and patient eligibility

About

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.

Full 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)

Enrollment: 20,000 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20,000 participants in 4 patient groups

Linked to national data

Description:

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

Description:

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

Description:

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

Description:

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