The Indigo 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.
We have a wonderful expert advisory group composed of Pr Laura Ashley (from Leeds Becket University), Dr Anthony Cunliffe (from Macmillan Cancer Support), Garry Davenport (from Macmillan Cancer Support), Jacqui Gath (from Independent Cancer Patients' Voice), Dr Kendall Jamieson Gilmore (from The National Institute for Health and Care Excellence, NICE), Clara Miglio (from Macmillan Cancer Support), Danny Ruta (from Guy’s Cancer Centre), Pete Wheatstone (Patient Partner), Dr Helen Williams (from The Word Desk Ltd).
Thank you if you have already expressed interest in becoming a Patient Partner. We will do our best to contact you over the next 6 weeks however we are now closed to recruitment for this role.
If you would still like to be involved in shaping our research please email us and we will be in touch when we next hold a focus group.
Opened in December 2023
Clinical trial: NCT06095024
CPMS ID: 56060
IRAS ID: 324034
CI: Dr. Matt Williams
Clinical lead: Dr. Jonathan Gregory
Lead analyst: Ms. Kerlann Le Calvez
PPIE lead: Lillie Pakzad-Shahabi
Outcome measures
1
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.
2
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.
3
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.
Inclusion Criteria
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Anyone over the age of 16 who has been diagnosed (receiving treatment is not an inclusion criteria although we 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.
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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.
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Have capacity and be able to provide informed consent via the online platform.
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To be able to understand, read and write English, with or without support from a trusted individual e.g., friends, family, carer.
Exclusion Criteria
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Participants recently diagnosed with cancer (less than 12 months ago).
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Participants unable to access secure online platforms.
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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.
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Participants lacking capacity and unable to give informed consent.