Colorectal CancerTEMPONCT05408169
Increasing Uptake of Bowel Screening
A study testing Suggested deadline for return of screening test and Planning sheet in people with Colorectal Cancer, run by University of Glasgow at 1 site in United Kingdom.
Trial 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%. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Suggested deadline for return of screening test and Planning sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-74 years
- Registered with a Community Health Index number in Scotland
- More than 2 years since last bowel screening invitation
Who cannot join
- Has self-excluded from Scottish Bowel Screening Programme
- Not sent a screening kit by the Scottish Bowel Screening Programme
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Colorectal Cancer
- Being tested
- Suggested deadline for return of screening test, Planning sheet
- Keywords
- Early Detection of Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suggested deadline for return of screening testBehavioural
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 sheetBehavioural
Also called Volitional help 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| 1-week deadline, no planning sheet | Experimental | Not described Receives: Behavioral: Suggested deadline for return of screening test |
| 2-week deadline, no planning sheet | Experimental | Not described Receives: Behavioral: Suggested deadline for return of screening test |
| 4-week deadline, no planning sheet | Experimental | Not described Receives: Behavioral: Suggested deadline for return of screening test |
| No deadline, with planning sheet | Experimental | Not described Receives: Behavioral: Planning sheet |
| 1-week deadline, with planning sheet | Experimental | Not described Receives: Behavioral: Suggested deadline for return of screening test; Behavioral: Planning sheet |
| 2-week deadline, with planning sheet | Experimental | Not described Receives: Behavioral: Suggested deadline for return of screening test; Behavioral: Planning sheet |
| 4-week deadline, with planning sheet | Experimental | Not described Receives: Behavioral: Suggested deadline for return of screening test; Behavioral: Planning sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of screening tests returned to the central laboratory and successfully processed providing an adequate result.
Measured: 3 months
Secondary outcomes (6)
Number of screening tests returned to the central laboratory
Measured: 3 months
Number of screening tests returned to the central laboratory within suggested deadline
Measured: 1/2/4 weeks
Number of screening tests returned to the central laboratory by area-level deprivation
Measured: 3 months
Cognitive and behavioural mechanisms
A questionnaire designed to assess mechanisms, e.g. action and coping planning, using items adapted for the bowel screening context.
Measured: 3 months
Acceptability of interventions (quantitative)
The Acceptability Questionnaire
Measured: 3 months
Acceptability of interventions (qualitative)
Analysis of in-depth semi-structured interviews.
Measured: 3-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start20 Jun 2022
- Primary completion3 Oct 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, NHS Tayside, University of Cambridge, University of St Andrews, University of Stirling, University of Dundee, Chief Scientist Office of the Scottish Government, Cancer Research UK
- Responsible party
- Principal investigator, Katie Robb, University of Glasgow
- Investigators
- Katie Robb, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408169
- Sponsor's protocol ID
- GN19GA165
- Acronym
- TEMPO
- Status last verified
- Dec 2023
- First submitted
- 29 Apr 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40088914Robb 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.
PubMed 37202130
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05408169
- Acronym / sponsor ID
- TEMPO / GN19GA165
- Conditions
- Colorectal Cancer
- Keywords
- Early Detection of Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40,000 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, NHS Tayside, University of Cambridge, University of St Andrews, University of Stirling, University of Dundee, Chief Scientist Office of the Scottish Government, Cancer Research UK
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| 1-week deadline, no planning sheet | Experimental | Behavioral: Suggested deadline for return of screening test |
| 2-week deadline, no planning sheet | Experimental | Behavioral: Suggested deadline for return of screening test |
| 4-week deadline, no planning sheet | Experimental | Behavioral: Suggested deadline for return of screening test |
| No deadline, with planning sheet | Experimental | Behavioral: Planning sheet |
| 1-week deadline, with planning sheet | Experimental | Behavioral: Suggested deadline for return of screening test, Behavioral: Planning sheet |
| 2-week deadline, with planning sheet | Experimental | Behavioral: Suggested deadline for return of screening test, Behavioral: Planning sheet |
| 4-week deadline, with planning sheet | Experimental | Behavioral: Suggested deadline for return of screening test, Behavioral: Planning sheet |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50-74 years
- Registered with a Community Health Index number in Scotland
- More than 2 years since last bowel screening invitation
Key exclusion criteria (2 listed)
- Has self-excluded from Scottish Bowel Screening Programme
- Not sent a screening kit by the Scottish Bowel Screening Programme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suggested deadline for return of screening testA 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." | Behavioural | 1-week deadline, no planning sheet, 1-week deadline, with planning sheet, 2-week deadline, no planning sheet, 2-week deadline, with planning sheet, 4-week deadline, no planning sheet, 4-week deadline, with planning sheet |
| Planning sheetAlso: Volitional help sheetA 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. | Behavioural | 1-week deadline, with planning sheet, 2-week deadline, with planning sheet, 4-week deadline, with planning sheet, No deadline, with planning sheet |
Primary outcome
Number of screening tests returned to the central laboratory and successfully processed providing an adequate result.
Time frame: 3 months
6 secondary outcomes
Number of screening tests returned to the central laboratory
Time frame: 3 months
Number of screening tests returned to the central laboratory within suggested deadline
Time frame: 1/2/4 weeks
Number of screening tests returned to the central laboratory by area-level deprivation
Time frame: 3 months
Cognitive and behavioural mechanisms
Time frame: 3 months
Acceptability of interventions (quantitative)
Time frame: 3 months
Acceptability of interventions (qualitative)
Time frame: 3-8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 40088914Robb 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.
- Derived from this study: PubMed 37202130Robb 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Robb principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suggested deadline for return of screening test and Planning sheet in people with Colorectal Cancer, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of screening tests returned to the central laboratory and successfully processed providing an adequate result. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05408169, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.