INvestigating DIGital Outcomes in the Community
- Conditions
- Cancer
- Registration Number
- NCT06095024
- Lead Sponsor
- Imperial College London
- 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)
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Agreement to link to national cancer data 12 months Proportion of patients agreeing to link their data to national cancer data
Completion of study questionnaire 12 months Proportion of patients completing the entire study questionnaire
- Secondary Outcome Measures
Name Time Method Effectiveness of different communication channels for recruitment 12 months Enrolment rate via different recruitment channels (Primary Care Research Network, Social Media) expressed as the proportion of patient recruited via each channel
Completion of PROMs questionnaires 12 months Proportion of patients completing PROMS questionnaires
Satisfaction with questionnaires 12 months 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
Correlation of each PROM score with quality of life 12 months Correlation of each PROM score with the EuroQol 5 Dimensions, 5 levels (EQ5D-5L) quality of life measure
Trial Locations
- Locations (1)
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom