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Completed

NCT Number: NCT05408169

Increasing Uptake of Bowel Screening

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.

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Key information

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scottish Bowel Screening Centre

Dundee, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suggested deadline for return of screening test

Behavioral

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

Behavioral

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

Primary outcomes

  1. Number of screening tests returned to the central laboratory and successfully processed providing an adequate result.

    Time frame: 3 months

Secondary outcomes

  1. Number of screening tests returned to the central laboratory

    Time frame: 3 months

  2. Number of screening tests returned to the central laboratory within suggested deadline

    Time frame: 1/2/4 weeks

  3. Number of screening tests returned to the central laboratory by area-level deprivation

    Time frame: 3 months

  4. Cognitive and behavioural mechanisms

    Time frame: 3 months

    A questionnaire designed to assess mechanisms, e.g. action and coping planning, using items adapted for the bowel screening context.

  5. Acceptability of interventions (quantitative)

    Time frame: 3 months

    The Acceptability Questionnaire

  6. Acceptability of interventions (qualitative)

    Time frame: 3-8 months

    Analysis of in-depth semi-structured interviews.

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • 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

Registry information

Official study title

Increasing Uptake of Faecal Immunochemical Test (FIT) Bowel Screening: Trial of Providing a Suggested Deadline for FIT Kit Return and a Planning Sheet

Acronym: TEMPO

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 7, 2022
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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