INvestigating DIGital Outcomes in the Community

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

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

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Linked to national data<br>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<br>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<br>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<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |