Clinical trial NCT05408169: Increasing Uptake of Bowel Screening
Official title: Increasing Uptake of Faecal Immunochemical Test (FIT) Bowel Screening: Trial of Providing a Suggested Deadline for FIT Kit Return and a Planning Sheet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Early Detection of Cancer
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
name: NHS Tayside
name: University of Cambridge
name: University of St Andrews
name: University of Stirling
name: University of Dundee
name: Chief Scientist Office of the Scottish Government
name: Cancer Research UK
First posted: 2022-06-07
Enrollment: 40000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Bowel cancer is the second biggest cancer killer in the UK, accounting for over 16,000 deaths per year. Screening can reduce deaths from bowel cancer if the people invited participate. The challenge is that high uptake of bowel screening is hard to achieve, and remains persistently below 65%.

The faecal immunochemical test (FIT) is the most widely used bowel screening test worldwide.

In the UK, FIT kits are mailed to people's homes without guidance on when the kit should be returned and only brief instruction on how to use it. Some people have said that even though they intend to complete and return the kit, they often forget or put off doing it.

Two approaches are proposed to addressing this issue: i) providing a suggested deadline for FIT return, because it is known from breast and cervical cancer screening that giving people an appointment time increases uptake compared to an open invitation, and ii) planning sheets, that have been found to help people act on their intentions in other health contexts.

This trial aims to evaluate the impact of providing a suggested deadline and a planning sheet on the return of FIT bowel screening kits.

The trial is integrated within the Scottish Bowel Screening Programme. The investigators will randomly allocate 40,000 consecutive people that are due to be sent a FIT kit to one of eight groups:

(i) control group (no deadline, no planning sheet), (ii) intervention group (1-week deadline, no planning sheet), (iii) intervention group (2-week deadline, no planning sheet), (iv) intervention group (4-week deadline, no planning sheet), (v) intervention group (no deadline, with planning sheet), (vi) intervention group (1-week deadline, with planning sheet), (vii) intervention group (2-week deadline, with planning sheet), (viii) intervention group (4-week deadline, with planning sheet).

It will then be examined if having a suggested deadline and a planning sheet affects how many people send back their completed FIT kit. It will also be examined if the deadline length makes a difference and whether having both a deadline and a planning sheet affects the number of people returning their kit.

Finally, the cognitive and behavioural mechanisms underlying any intervention effects will be assessed and the acceptability of the interventions explored, using questionnaires and in-depth interviews.


Eligibility criteria: Inclusion Criteria:

* 50-74 years
* Registered with a Community Health Index number in Scotland
* More than 2 years since last bowel screening invitation

Exclusion Criteria:

* Has self-excluded from Scottish Bowel Screening Programme
* Not sent a screening kit by the Scottish Bowel Screening Programme

Primary outcomes:
measure: Number of screening tests returned to the central laboratory and successfully processed providing an adequate result.
timeFrame: 3 months
Secondary outcomes:
measure: Number of screening tests returned to the central laboratory
timeFrame: 3 months
measure: Number of screening tests returned to the central laboratory within suggested deadline
timeFrame: 1/2/4 weeks
measure: Number of screening tests returned to the central laboratory by area-level deprivation
timeFrame: 3 months
measure: Cognitive and behavioural mechanisms
timeFrame: 3 months
measure: Acceptability of interventions (quantitative)
timeFrame: 3 months
measure: Acceptability of interventions (qualitative)
timeFrame: 3-8 months
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Scottish Bowel Screening Centre
Study officials:
affiliation: University of Glasgow
name: Katie Robb
role: PRINCIPAL_INVESTIGATOR
References: