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
To assess the feasibility of recruiting to a community digital Patient Reported Outcomes Measures (PROMs) study via the primary care research network.
Feasibility of linking participants PROMs to regional and national data sets.
Secondary outcome measures
Feasibility of different methods of communication to trigger participant self-identification and self-enrolment into a digitally administered community cancer PROMs study.
To assess which of three PROMs participants identify as most useful to them in combination with EQ-5D-5L.
Tertiary outcome measures
The feasibility of collecting, filtering, grouping, and interpreting free text responses in the context of a digital community-based PROM study.
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.