Clinical trial NCT06095024: INvestigating DIGital Outcomes in the Community
Official title: INDIGO Community Participant Led Electronic Completion of PROMs and PREMs for Patients Living With and Beyond Cancer in the Community
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2023-10-23
Enrollment: 20000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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)

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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Completion of study questionnaire
timeFrame: 12 months
measure: Agreement to link to national cancer data
timeFrame: 12 months
Secondary outcomes:
measure: Completion of PROMs questionnaires
timeFrame: 12 months
measure: Satisfaction with questionnaires
timeFrame: 12 months
measure: Effectiveness of different communication channels for recruitment
timeFrame: 12 months
measure: Correlation of each PROM score with quality of life
timeFrame: 12 months
Other outcomes:
measure: The feasibility of developing a national longitudinal cohort
timeFrame: 12 months
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College Healthcare Trust
name: Matthew Williams, MBChB PhD FRCR
role: PRINCIPAL_INVESTIGATOR
References: