INDIGO COMMUNITY
Clinical trial NCT06095024
REC and HRA approvals obtained and we aim to open in December 2023
The Indigo Community project is a digital clinical trial that aims to assess the feasibility of mass recruitment to a community cancer survivor study via a large-scale online platform using participant self-enrolment. Our ambition is to develop a firm, pragmatic evidence based on how to collect patient reported data for people living in the community who have previously been treated for cancer.
We have set a series of outcome measures to understand if and how this digital clinical trial evolves in the cancer patient community.
Co-primary outcome measures
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To assess the feasibility of recruiting to a community digital Patient Reported Outcomes Measures (PROMs) study via the primary care research network.
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Feasibility of linking participants PROMs to regional and national data sets.
Secondary outcome measures
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Feasibility of different methods of communication to trigger participant self-identification and self-enrolment into a digitally administered community cancer PROMs study.
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To assess which of three PROMs participants identify as most useful to them in combination with EQ-5D-5L.
Tertiary outcome measures
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The feasibility of collecting, filtering, grouping, and interpreting free text responses in the context of a digital community-based PROM study.
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The feasibility of developing a national cohort of people living with and beyond cancer with linked registry datasets who can be followed longitudinally with repeat sampling.