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Trial Title:
INvestigating DIGital Outcomes in the Community
NCT ID:
NCT06095024
Condition:
Cancer
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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)
Criteria for eligibility:
Study pop:
All adults living with a previous diagnosis of cancer in a defined geographical area (NW
London in stage 1; nationally in stage 2)
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Imperial College Healthcare NHS Trust
Address:
City:
London
Zip:
W6 8RF
Country:
United Kingdom
Contact:
Last name:
Kerlann Le Calvez, MSc
Contact backup:
Last name:
Matthew Williams, MBChB PhD
Email:
matthew.williams@imperial.ac.uk
Start date:
December 1, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Imperial College London
Agency class:
Other
Collaborator:
Agency:
Imperial College Healthcare NHS Trust
Agency class:
Other
Source:
Imperial College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06095024
