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

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Suggested deadline for return of screening test; Behavioral: Planning sheet

• Study Type: Interventional
• Enrollment (Actual): 40000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Dundee, United Kingdom
    • Scottish Bowel Screening Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: 1-week deadline, no planning sheet	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."
Experimental: 2-week deadline, no planning sheet	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."
Experimental: 4-week deadline, no planning sheet	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."
Experimental: No deadline, with planning sheet	Behavioral: 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 Names: Volitional help sheet
Experimental: 1-week deadline, with planning sheet	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."; Behavioral: 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 Names: Volitional help sheet
Experimental: 2-week deadline, with planning sheet	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."; Behavioral: 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 Names: Volitional help sheet
Experimental: 4-week deadline, with planning sheet	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."; Behavioral: 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 Names: Volitional help sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of screening tests returned to the central laboratory and successfully processed providing an adequate result.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A questionnaire designed to assess mechanisms, e.g. action and coping planning, using items adapted for the bowel screening context.	3 months
Acceptability of interventions (quantitative)	The Acceptability Questionnaire	3 months
Acceptability of interventions (qualitative)	Analysis of in-depth semi-structured interviews.	3-8 months

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: Cancer Research UK; University of Cambridge; NHS Tayside; University of Dundee; NHS Greater Glasgow and Clyde; University of St Andrews; Chief Scientist Office of the Scottish Government; University of Stirling
• Investigators: Principal Investigator: Katie Robb, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): October 3, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Early Detection of Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: GN19GA165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No