Increasing Uptake of Bowel Screening

Colorectal Cancer Clinical Trial

— TEMPO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408169
• Other study ID #: GN19GA165
• Status: Completed
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40000
• Est. completion date: June 30, 2023
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	Scottish Bowel Screening Centre	Dundee

Sponsors (9)

Lead Sponsor	Collaborator
University of Glasgow	Cancer Research UK, Chief Scientist Office of the Scottish Government, NHS Greater Glasgow and Clyde, NHS Tayside, University of Cambridge, University of Dundee, University of St Andrews, University of Stirling

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of screening tests returned to the central laboratory and successfully processed providing an adequate result.		3 months
Secondary	Number of screening tests returned to the central laboratory		3 months
Secondary	Number of screening tests returned to the central laboratory within suggested deadline		1/2/4 weeks
Secondary	Number of screening tests returned to the central laboratory by area-level deprivation		3 months
Secondary	Cognitive and behavioural mechanisms	A questionnaire designed to assess mechanisms, e.g. action and coping planning, using items adapted for the bowel screening context.	3 months
Secondary	Acceptability of interventions (quantitative)	The Acceptability Questionnaire	3 months
Secondary	Acceptability of interventions (qualitative)	Analysis of in-depth semi-structured interviews.	3-8 months