Increasing Uptake of Bowel Screening
TEMPO
Increasing Uptake of Faecal Immunochemical Test (FIT) Bowel Screening: Trial of Providing a Suggested Deadline for FIT Kit Return and a Planning Sheet
1 other identifier
interventional
40,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Jun 2022
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2022
CompletedFirst Posted
Study publicly available on registry
June 7, 2022
CompletedStudy Start
First participant enrolled
June 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedDecember 11, 2023
December 1, 2023
4 months
April 29, 2022
December 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of screening tests returned to the central laboratory and successfully processed providing an adequate result.
3 months
Secondary Outcomes (6)
Number of screening tests returned to the central laboratory
3 months
Number of screening tests returned to the central laboratory within suggested deadline
1/2/4 weeks
Number of screening tests returned to the central laboratory by area-level deprivation
3 months
Cognitive and behavioural mechanisms
3 months
Acceptability of interventions (quantitative)
3 months
- +1 more secondary outcomes
Study Arms (8)
Control
NO INTERVENTION1-week deadline, no planning sheet
EXPERIMENTAL2-week deadline, no planning sheet
EXPERIMENTAL4-week deadline, no planning sheet
EXPERIMENTALNo deadline, with planning sheet
EXPERIMENTAL1-week deadline, with planning sheet
EXPERIMENTAL2-week deadline, with planning sheet
EXPERIMENTAL4-week deadline, with planning sheet
EXPERIMENTALInterventions
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."
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.
Eligibility Criteria
You may qualify if:
- years
- Registered with a Community Health Index number in Scotland
- More than 2 years since last bowel screening invitation
You may not qualify if:
- Has self-excluded from Scottish Bowel Screening Programme
- Not sent a screening kit by the Scottish Bowel Screening Programme
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Glasgowlead
- NHS Greater Glasgow and Clydecollaborator
- NHS Taysidecollaborator
- University of Cambridgecollaborator
- University of St Andrewscollaborator
- University of Stirlingcollaborator
- University of Dundeecollaborator
- Chief Scientist Office of the Scottish Governmentcollaborator
- Cancer Research UKcollaborator
Study Sites (1)
Scottish Bowel Screening Centre
Dundee, United Kingdom
Related Publications (2)
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.
PMID: 40088914DERIVEDRobb 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.
PMID: 37202130DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katie Robb
University of Glasgow
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Behavioural Science and Health
Study Record Dates
First Submitted
April 29, 2022
First Posted
June 7, 2022
Study Start
June 20, 2022
Primary Completion
October 3, 2022
Study Completion
June 30, 2023
Last Updated
December 11, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Outcomes 1-4: 5 years post completion and data then moved to off-line storage. Outcomes 5-6: 10 years from date of deposition in the first instance, with extensions applied to datasets which are subsequently accessed.
- Access Criteria
- Outcomes 1-4: There is no requirement for a data sharing agreement with the research team and no restrictions on data sharing. Any research group can approach and request permission to use datasets. Outcomes 5-6: Data made public at the time of publication.
Outcomes 1-4: Details of the dataset and work arising from it will be available from the Robertson Centre for Biostatistics Analytical Platform at the University of Glasgow. The dataset will be archived on live servers within the facility. Use of anonymised data within research is given for the specified project purpose, future use is permitted but would require permission from LPAC and the Caldicott Guardian. Outcomes 5-6: Quantitative data (SPSS files with metadata) and qualitative data (stored as MSword transcripts with metadata) will be deposited in Enlighten: Research Data, the University of Glasgow's institutional data repository. Data in the repository will be stored in accordance with funder and University data policies. Files will be given a Digital Object Identifier (DOI) and the associated metadata will be listed in the University of Glasgow Research Data Registry and the DataCite metadata store.