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Clinical Trials/NCT06095024
NCT06095024
Not Yet Recruiting
N/A

INDIGO Community Participant Led Electronic Completion of PROMs and PREMs for Patients Living With and Beyond Cancer in the Community

Imperial College London1 site in 1 country20,000 target enrollmentDecember 1, 2023
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
Imperial College London
Enrollment
20000
Locations
1
Primary Endpoint
Completion of study questionnaire
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
June 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Completion of study questionnaire

Time Frame: 12 months

Proportion of patients completing the entire study questionnaire

Agreement to link to national cancer data

Time Frame: 12 months

Proportion of patients agreeing to link their data to national cancer data

Secondary Outcomes

  • Effectiveness of different communication channels for recruitment(12 months)
  • Completion of PROMs questionnaires(12 months)
  • Satisfaction with questionnaires(12 months)
  • Correlation of each PROM score with quality of life(12 months)

Study Sites (1)

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