Condition category
Cancer
Date applied
21/04/2015
Date assigned
16/07/2015
Last edited
28/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Bowel cancer is the second most common cause of cancer death in the UK. Early diagnosis improves survival and in light of this the NHS established the Bowel Cancer Screening Programme (BCSP). This Programme offers screening using a stool testing kit (the faecal occult blood test) to 60-74 year olds. Data from 2012 shows that only 53% of those offered screening take it up and that this varies from more than 60% in the most socially advantaged areas of the country to less than 35% in the most disadvantaged areas. This study aims to increase uptake in the BCSP, and to reduce differences in uptake between the most and least socially advantaged groups, whilst ensuring that uptake does not decline in any socioeconomic (SE) group. The study will test whether or not receiving an endorsement from your GP at the same time that you receive a kit as part of the BCSP is likely to increase uptake and/or reduce SE inequalities.

Who can participate?
Individuals who are routinely invited for screening in the BCSP (age 60-74 with a registered GP).

What does the study involve?
Participants will be randomly allocated either to receive an invitation letter with a GP endorsement or the standard letter currently sent out by the BCSP without an endorsement.

What are the possible benefits and risks of participating?
No benefits or risks are expected as the study is carried out within the participant’s standard care pathway as part of the Bowel Cancer Screening Programme – the usual benefits and risks of participating in the Bowel Cancer Screening Programme would still apply.

Where is the study run from?
Imperial College London (UK)

When is the study starting and how long is it expected to run for?
March to December 2015

Who is funding the study?
University College London (UK)

Who is the main contact?
Dr Laura Turner

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paula Kirby

ORCID ID

Contact details

Cancer Screening and Prevention Research Group
Department of Surgery and Cancer
Imperial College London
St Mary’s Campus
Room 505
Medical School Building
Norfolk Place
London
W2 1PG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0 17/03/2015

Study information

Scientific title

General practice endorsement in the Bowel Cancer Screening Programme: the ASCEND2 project

Acronym

ASCEND2

Study hypothesis

Receiving an endorsement from the GP at the same time that you receive a screening kit as part of the NHS Bowel Cancer Screening Programme (BCSP) is likely to increase uptake rates and reduce socioeconomic (SE) inequalities in uptake.

Ethics approval

East Midlands REC, 07/12/2015, ref: 15/EM/0561

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal cancer/bowel cancer

Intervention

ASCEND2 will compare the effectiveness of using a general practice endorsement banner on kit invitation letters sent as part of the BCSP, against the standard letter currently sent out by the BCSP. Individuals who are routinely invited for screening in the BCSP in England will be allocated to receive an intervention on randomly selected days within a pre-specified time period (cluster randomisation).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Proportion of people in each Index of Multiple Deprivation (IMD) quintile returning an adequate faecal occult blood test (FOBt) within 18 weeks of being sent their initial invitation letter. An adequate FOBt in this study is defined as reaching a definitive FOBt outcome of either a 'Normal' (no further clinical investigation is required) or 'Abnormal' (referral for prospective colonoscopy).

Secondary outcome measures

1. Time taken to return FOBt by IMD quintile
2. Proportion of spoilt kits and their relationship to IMD quintile
3. Proportion of non-delivered kits by IMD quintile
4. Incremental cost per screening invitation
5. Incremental cost per screening invitation, both by IMD quintile and overall
6. All of the above outcomes analysed using other SE variables

Overall trial start date

01/03/2015

Overall trial end date

31/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Men and women aged between 60-74 years who have a registered GP

Participant type

Other

Age group

Senior

Gender

Both

Target number of participants

97616

Participant exclusion criteria

1. We will only be able to randomise eligible people to receive this intervention if they are registered with practices that agreed to endorse the BCSP during the preceding trial, ASCEND.
2. Invited subjects may contact their BCSP hub and opt-out of the current screening episode and others for reasons of informed choice or poor health and they can choose to be ceased from the screening programme. 'Ceased' subjects, if ceased prior to their screening due date will not be invited to be screened.

Recruitment start date

01/02/2016

Recruitment end date

11/03/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Bowel Cancer Screening Programme
-
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

South Kensington
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University College London

Alternative name(s)

UCL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Source data contains patient identifiers and is the property of the NHS BCSP so will therefore not be freely available. Once processed, cleaned and anonymised study data will then be stored in a repository as per sponsor (Imperial College) guidelines.

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added. 12/11/2015: the following changes were made to the trial record: 1. The recruitment start date was changed from 06/07/2015 to 01/02/2016. 2. The recruitment end date was changed from 31/07/2015 to 11/03/2016. 3. The overall trial end date was changed from 31/12/2015 to 31/08/2016.