Increasing Uptake of Bowel Screening

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Suggested deadline for return of screening test
* Behavioral: Planning sheet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: 1-week deadline, no planning sheet<br> | Behavioral: Suggested deadline for return of screening test<br>* 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.<br>|
| Experimental: 2-week deadline, no planning sheet<br> | Behavioral: Suggested deadline for return of screening test<br>* 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.<br>|
| Experimental: 4-week deadline, no planning sheet<br> | Behavioral: Suggested deadline for return of screening test<br>* 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.<br>|
| Experimental: No deadline, with planning sheet<br> | Behavioral: Planning sheet<br>* 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.<br>* Other names: Volitional help sheet;|
| Experimental: 1-week deadline, with planning sheet<br> | Behavioral: Suggested deadline for return of screening test<br>* 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.<br>Behavioral: Planning sheet<br>* 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.<br>* Other names: Volitional help sheet;|
| Experimental: 2-week deadline, with planning sheet<br> | Behavioral: Suggested deadline for return of screening test<br>* 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.<br>Behavioral: Planning sheet<br>* 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.<br>* Other names: Volitional help sheet;|
| Experimental: 4-week deadline, with planning sheet<br> | Behavioral: Suggested deadline for return of screening test<br>* 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.<br>Behavioral: Planning sheet<br>* 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.<br>* Other names: Volitional help sheet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Detection of Cancer