Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40000 participants
INTERVENTIONAL
2022-06-20
2023-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Control
No interventions assigned to this group
1-week deadline, no planning sheet
Suggested deadline for return of screening test
A screening invitation letter modified to state, highlighted in yellow: "Please return your kit within \[X\] weeks (by \[DD.MM.YYYY\]) or as soon as possible."
2-week deadline, no planning sheet
Suggested deadline for return of screening test
A screening invitation letter modified to state, highlighted in yellow: "Please return your kit within \[X\] weeks (by \[DD.MM.YYYY\]) or as soon as possible."
4-week deadline, no planning sheet
Suggested deadline for return of screening test
A screening invitation letter modified to state, highlighted in yellow: "Please return your kit within \[X\] weeks (by \[DD.MM.YYYY\]) or as soon as possible."
No deadline, with planning sheet
Planning sheet
A planning tool presented on a separate single sheet of paper inserted into the screening invitation envelope. The colour illustrated tool prompts participants to identify concerns they have with using the bowel screening kit and to link them to a tip to help them overcome this concern.
1-week deadline, with planning sheet
Suggested deadline for return of screening test
A screening invitation letter modified to state, highlighted in yellow: "Please return your kit within \[X\] weeks (by \[DD.MM.YYYY\]) or as soon as possible."
Planning sheet
A planning tool presented on a separate single sheet of paper inserted into the screening invitation envelope. The colour illustrated tool prompts participants to identify concerns they have with using the bowel screening kit and to link them to a tip to help them overcome this concern.
2-week deadline, with planning sheet
Suggested deadline for return of screening test
A screening invitation letter modified to state, highlighted in yellow: "Please return your kit within \[X\] weeks (by \[DD.MM.YYYY\]) or as soon as possible."
Planning sheet
A planning tool presented on a separate single sheet of paper inserted into the screening invitation envelope. The colour illustrated tool prompts participants to identify concerns they have with using the bowel screening kit and to link them to a tip to help them overcome this concern.
4-week deadline, with planning sheet
Suggested deadline for return of screening test
A screening invitation letter modified to state, highlighted in yellow: "Please return your kit within \[X\] weeks (by \[DD.MM.YYYY\]) or as soon as possible."
Planning sheet
A planning tool presented on a separate single sheet of paper inserted into the screening invitation envelope. The colour illustrated tool prompts participants to identify concerns they have with using the bowel screening kit and to link them to a tip to help them overcome this concern.
Interventions
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Suggested deadline for return of screening test
A screening invitation letter modified to state, highlighted in yellow: "Please return your kit within \[X\] weeks (by \[DD.MM.YYYY\]) or as soon as possible."
Planning sheet
A planning tool presented on a separate single sheet of paper inserted into the screening invitation envelope. The colour illustrated tool prompts participants to identify concerns they have with using the bowel screening kit and to link them to a tip to help them overcome this concern.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Registered with a Community Health Index number in Scotland
* More than 2 years since last bowel screening invitation
Exclusion Criteria
* Not sent a screening kit by the Scottish Bowel Screening Programme
50 Years
74 Years
ALL
Yes
Sponsors
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NHS Greater Glasgow and Clyde
OTHER
NHS Tayside
OTHER_GOV
University of Cambridge
OTHER
University of St Andrews
OTHER
University of Stirling
OTHER
University of Dundee
OTHER
Chief Scientist Office of the Scottish Government
OTHER_GOV
Cancer Research UK
OTHER
University of Glasgow
OTHER
Responsible Party
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Katie Robb
Professor of Behavioural Science and Health
Principal Investigators
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Katie Robb
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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Scottish Bowel Screening Centre
Dundee, , United Kingdom
Countries
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References
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Robb KA, Young B, Murphy MK, Duklas P, McConnachie A, Hollands GJ, McCowan C, Macdonald S, O'Carroll RE, O'Connor RC, Steele RJC. Behavioural interventions to increase uptake of FIT colorectal screening in Scotland (TEMPO): a nationwide, eight-arm, factorial, randomised controlled trial. Lancet. 2025 Mar 29;405(10484):1081-1092. doi: 10.1016/S0140-6736(24)02813-7. Epub 2025 Mar 12.
Robb KA, Kotzur M, Young B, McCowan C, Hollands GJ, Irvine A, Macdonald S, McConnachie A, O'Carroll RE, O'Connor RC, Steele RJC. Increasing uptake of FIT colorectal screening: protocol for the TEMPO randomised controlled trial testing a suggested deadline and a planning tool. BMJ Open. 2023 May 18;13(5):e066136. doi: 10.1136/bmjopen-2022-066136.
Other Identifiers
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GN19GA165
Identifier Type: -
Identifier Source: org_study_id