Patient acceptability of FIT stool test and analysing a colorectal cancer risk tool

Not Applicable

• Conditions: Colorectal cancer; Cancer

• Registration Number: ISRCTN87120188
• Lead Sponsor: Croydon University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-16
• Last Update Posted: 30 January 2023
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Study 1:
1. Patients who have been offered but have not used FIT as part of their referral from primary to secondary care colorectal department within Croydon CCG but who have not completed a FIT (Referral via FIT Implementation pathway).
2. Adults (aged 18 to 110 years)
3. Patients will be able to read, understand and communicate their understanding of the patient information form and complete the consent form
4. Patients will be able to conduct telephone interviews in English

Study 2:
1. Patients who have been referred to Croydon University Hospital under the FIT Implementation pathway
2.1. Patients who have recorded: FHb, serum Hb, ferritin, age, gender and CRP as well as 2-week wait pathway diagnosis in electronic medical notes or:
2.2. Patients who have recorded: FHb, serum Hb, ferritin, age and gender as well as 2-week wait pathway diagnosis in electronic medical notes

Exclusion Criteria

Study 1:
1. Patients not offered FIT as part of 2-week wait referral
2. Patients not able to read, understand and communicate their understanding of the patient information form and consent form
3. Patients not able to conduct telephone interviews in English

Study 2:
1. Patients not referred under 2-week wait pathway to hospital
2. Patients without recorded faecal haemoglobin recorded
3. Patients with inadequate biochemical parameters recorded

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Study 1: Perceived barriers to using the faecal immunochemical test (FIT) for patients who have declined to use the test when offered it as part of their investigations for potential colorectal cancer symptoms, measured using qualitative interviews, completed after patient investigations and diagnosis completed. Analysis through grounded theory analysis.<br> Study 2: Factors that would increase the likelihood of patients using FIT when offered as an initial investigation for suspected colorectal cancer symptoms, measured using qualitative interviews, completed after patient investigations and diagnosis completed. Analysis through grounded theory analysis.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Study 1: Diagnostic accuracy of colorectal cancer risk tool compared to faecal haemoglobin alone, measured through predicted % risk of colorectal cancer using risk tool and % risk of colorectal cancer using faecal haemoglobin alone, compared to diagnostic cancer outcomes of patients following completion of two weeks wait investigations.<br> Study 2: Sensitivity and specificity of risk tool for colorectal cancer measured by selecting % of patients predicted to have colorectal cancer at set risk thresholds compared to diagnostic cancer outcomes of patients following completion of two-week wait investigations.<br>