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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Participants need to be able to access the secure online platform, using a mobile device or computer.
Exclusion Criteria:
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All adults living with a previous diagnosis of cancer in a defined geographical area (NW London in stage 1; nationally in stage 2)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerlann Le Calvez, MSc | Contact | 0203 311 8427 | kerlann.lecalvez@nhs.net | |
| Matthew Williams, MBChB PhD | Contact | matthew.williams@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Williams, MBChB PhD FRCR | Imperial College Healthcare Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W6 8RF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40921632 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 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 |