Trial recruitment
How many patients are involved?
Formal sample size calculation has not been carried out for this feasibility study
Each month during the course of 18 months, we will determine patients’ eligibility under NICE guidelines. We aim to include electronic primary care records of 20,000 patients aged 60 to 79. Since about 17% of the population is aged 60 to 79 this requires about 118,000 registered patients.
We estimated the number of test positive and true positive cases among 20,000 persons aged 60 to 79. Over 18 months we expect 60 diagnoses of colorectal cancer in these 20,000 persons. We expect 1007 to meet NICE urgent referral criteria of whom 25 will have cancer. Per month this is 56 patients potentially for urgent referral: 3 per practice.
Who can enter?
Initial investigation: All those who meet NICE referral criteria will be identified and their medical records reviewed by the GP and/or practice staff to determine if:
- their recorded symptoms already have an explanatory diagnosis, including existing colorectal cancer;
- they are already under investigation for colorectal cancer;
- they have declined further investigation;
- there are clinical contraindications to further investigation (e.g. because of comorbidities); or the GP was unaware that they need further investigation.
Invitation and further investigation: Patients eligible for further investigation will be contacted, provided with further information and offered an invitation to attend a clinical team specialising in the management of lower gastrointestinal cancer.
Follow up and final diagnosis: Investigation and diagnosis will follow standard NHS procedure. The researcher will ask the practice to access records to determine final diagnoses at least six months after identification. Public Health England (PHE) records will be sought to confirm whether identified patients participated in bowel cancer screening.
- Electronic copies of trial documentation