General practice endorsement in the Bowel Cancer Screening Programme
| ISRCTN | ISRCTN11660314 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11660314 |
| Secondary identifying numbers | 1.0 17/03/2015 |
- Submission date
- 21/04/2015
- Registration date
- 16/07/2015
- Last edited
- 09/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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 Amanda Cross
Contact information
Scientific
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
 ORCID ID |
0000-0002-0893-2377 |
|---|
Study information
| Study design | Interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | General practice endorsement in the Bowel Cancer Screening Programme: the ASCEND2 project |
| Study 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(s) | East Midlands REC, 07/12/2015, ref: 15/EM/0561 |
| 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 |
| Primary outcome measure | 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 study start date | 01/03/2015 |
| Overall study end date | 30/04/2018 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 97616 |
| Total final enrolment | 394842 |
| Participant inclusion criteria | Men and women aged between 60-74 years who have a registered GP |
| 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
Study participating centre
United Kingdom
Sponsor information
University/education
South Kensington
London
SW7 2AZ
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University College London in United Kingdom, Collegium Universitatis Londinensis, UCL
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 11/07/2018: Analysis and results publication expected in 2018-2019. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. 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. Previous publication and dissemination plan: Analysis and results publication expected in 2017. IPD sharing statement: The datasets generated during and/or analysed during the current study is not expected to be made available. 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/02/2021 | 11/03/2021 | Yes | No |
| Protocol file | version 1.0 | 11/11/2015 | 09/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
09/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
11/03/2021: Publication reference and total final enrolment added.
15/02/2019: Contact details updated, trial website added.
11/07/2018: The following changes have been made:
1. The trial end date has changed from 31/12/2017 to 30/04/2018.
2. The publication and dissemination plan has been updated.
3. The intention to publish date has been changed from 31/12/2017 to 30/04/2019.
16/08/2017: Trial end date changed from 31/08/2016 to 31/12/2017. IPD statement clarified.
24/03/2016: Ethics approval information added.
12/11/2015: Following changes made: 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.
