CancerINDIGO-ComNCT06095024
INvestigating DIGital Outcomes in the Community
An observational study of Cancer, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer
- How many people
- 20,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Matthew Williams, MBChB PhD contact
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W6 8RF
Kerlann Le Calvez, MSc
Matthew Williams, MBChB PhD, matthew.williams@imperial.ac.uk
About this study
Official title: 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.
Read the 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)
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Completion of study questionnaire
Proportion of patients completing the entire study questionnaire
Measured: 12 months
Agreement to link to national cancer data
Proportion of patients agreeing to link their data to national cancer data
Measured: 12 months
Secondary outcomes (4)
Completion of PROMs questionnaires
Proportion of patients completing PROMS questionnaires
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Matthew Williams, MBChB PhD FRCR, Principal investigator, Imperial College Healthcare Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095024
- Sponsor's protocol ID
- 000000
- Acronym
- INDIGO-Com
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared, where patients give permission, with the national cancer registration service. Future researchers may then access the data via that route.
Publications
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.
PubMed 40921632
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INDIGO Community Participant Led Electronic Completion of PROMs and PREMs for Patients Living With and Beyond Cancer in the Community
- ClinicalTrials.gov ID
- NCT06095024
- Acronym / sponsor ID
- INDIGO-Com / 000000
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completion of study questionnaire
Time frame: 12 months
Proportion of patients completing the entire study questionnaire
Agreement to link to national cancer data
Time frame: 12 months
Proportion of patients agreeing to link their data to national cancer data
4 secondary outcomes
Completion of PROMs questionnaires
Time frame: 12 months
Satisfaction with questionnaires
Time frame: 12 months
Effectiveness of different communication channels for recruitment
Time frame: 12 months
Correlation of each PROM score with quality of life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 40921632Le 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.
- Individual participant dataSharing planned: No. IPD will be shared, where patients give permission, with the national cancer registration service. Future researchers may then access the data via that route.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Williams, MBChB PhD contact
Matthew Williams, MBChB PhD FRCR principal investigator
Imperial College Healthcare Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerlann Le Calvez, MSc (0203 311 8427, kerlann.lecalvez@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of study questionnaire (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06095024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023; AzTrials last refreshed its copy on 3 Nov 2026.