Electronic Risk Assessment for Cancer for Patients in General Practice

Not Applicable

• Conditions: Cancer

• Registration Number: ISRCTN22560297
• Lead Sponsor: niversity of Exeter

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36940950/ (added 21/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-19
• Last Update Posted: 18 March 2024
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

Current participant inclusion criteria as of 23/01/2023:
We will not recruit participants to the main RCT. It is a cluster RCT with the clusters being GP practices across England.
Practices must host either EMIS, or SystmOne, principal clinical systems. Only practices completing an agreement to engage with the research processes and the intervention/control arms will be eligible; in a practice agreement the practice will confirm that a practice meeting has taken place and at least fifty per cent of their GPs have agreed to participate in the trial. Practices that are proposing a split or a merger are not eligible.
We will also run a series of nested studies which will involve the recruitment of patients:
1. Patient interviews to explore their experience of care following an eRAT trigger and
2. Patient use of health services and their quality of life following an eRAT trigger.
For 1. only intervention practices will participate, and we'll seek to recruit 12-18 patients for whom an eRAT triggered and the GP made a referral/order investigations.
For 2. intervention (N=28) and control (N=28) practices will be recruited, and we'll aim to recruit 140 patients from each arm. In the intervention arm this will be patients who received an eRAT trigger and for whom the GP made a referral/order investigations. In control practices, patients will be those for whom an eRAT would have trigger in the practice and for whom the GP made referral/order investigations. Patients will be invited to participate via the practice.

Previous participant inclusion criteria as of 13/01/2023 to 23/01/2023:
We will not recruit participants to the main RCT. It is a cluster RCT with the clusters being GP practices across England.
Practices must host either Microtest, or SystmOne, principal clinical systems. Only practices completing an agreement to engage with the research processes and the intervention/control arms will be eligible; in a practice agreement the practice will confirm that a practice meeting has taken place and at least fifty per cent of their GPs have agreed to participate in the trial. Practices that are proposing a split or a merger are not eligible.
We will also run a series of nested studies which will involve the recruitment of patients:
1. Patient interviews to explore their experience of care following an eRAT trigger and
2. Patient use of health services and their quality of life following an eRAT trigger.
For 1. only intervention practices will participate, and we'll seek to recruit 12-18 patients for whom an eRAT triggered and the GP made a referral/order investigations.
For 2. intervention (N=28) and control (N=28) practices will be recruited, and we'll aim to recruit 140 patients from each arm. In the intervention arm this will be patients who received an eRAT trigger and for whom the GP made a referral/order investigations. In control practices, patients will be those for whom an eRAT would have trigger in the practice and for whom the GP made referral/order investigations. Patients will be invited to participate via the practice.

Previous participant inclusion criteria:
We will not recruit participants to this RCT. It is a cluster RCT with the clusters being GP practices across England.
1. Practices must host either Microtest, SystmOne, or Vision principal clinical systems. Only practices completing an agreement to engage with the research processes and the intervention/control arms will be eligible; in a practice agreement

Exclusion Criteria

1. If a practice is planning to merge or restructure over the course of the trial (to the extent that the practice size will change by at least 10%) they will not be permitted to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of the combined six cancers diagnosed during 2-year follow-up that were at Stage 1/2 (early – cure likely) at diagnosis versus Stage 3/4 (late – cure not likely).