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 the light of this the NHS has established the Bowel Cancer Screening Programme. This Programme offers screening using a stool testing kit to 60 - 74 year olds in England. Recent data show 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. The aim of this study is to reduce differences in uptake between the most and least socially advantaged groups, without compromising uptake in any of the groups, in people registered in the Bowel Cancer Screening Programme.
Who can participate?
Men and women aged between 60-74 eligible to be screened for bowel cancer.
What does the study involve?
We will examine the effectiveness, cost and cost effectiveness of four simple changes that can be easily built into the current Bowel Cancer Screening Programme delivery system. The four changes consist of two different information leaflets to be added to the invitation packs, the addition of the GP practice name to the invitation letter, and the addition of more information to the reminder letters. Participants will be randomly allocated to receive either one of the four modified invitations or the usual invitation.
What are the possible benefits and risks of participating?
There are no risks to the participants associated with these interventions.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
November 2012 to August 2013
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof Rosalind Raine
r.raine@ucl.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Prof Rosalind Raine
ORCID ID
Contact details
University College London
Department of Applied Health Research
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
+44 (0)207 679 1713
r.raine@ucl.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
13127
Study information
Scientific title
Strategies to reduce the social gradient in bowel cancer screening: the ASCEND project
Acronym
Study hypothesis
Socioeconomic inequalities in screening uptake within the Bowel Cancer Screening Programme can be reduced by modifying the information about cancer screening sent routinely to the eligible population.
Ethics approval(s)
London - Harrow Research Ethics Committee, 25/09/2012, ref: 12/LO/1396
Study design
Cluster randomised controlled trials
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
Other
Study 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
Intervention
All of the interventions listed below will be tested against usual practice in Bowel Cancer Screening Programme.
1. Gist intervention:
This is an information leaflet which offers two levels of information about the screening programme beginning with four brief statements encapsulating the main aims of bowel cancer screening programme, followed by two pages offering additional details in simple language. This leaflet contains clear signposting to allow respondents to select the information style that suits them, including a reference to the booklet which contains more detailed information and is already part of the standard invitation pack in the Bowel Cancer Screening Programme.
2. Narrative intervention:
This is an information leaflet containing narratives and photographs of real people ('messengers') who took part in screening and with whom individuals from the lower socioeconomic strata are more likely to identify. This leaflet will be sent with the usual invitation used in the Bowel Cancer Screening Programme.
3. General Practice Endorsement intervention:
This is an invitation letter modified so that it includes the individual's GP practice name in a statement of support for the Bowel Cancer Screening Programme.
4. Enhanced Reminder intervention:
This is a modified letter containing two paragraphs to make it more memorable and inviting to the potential participants. The paragraphs are focused on conveying the information about increased risk of getting cancer with age and also drawing the recipient's attention to the fact that the letter is a reminder.
Intervention type
Other
Primary outcome measure
The proportion of people in each socioeconomic group returning an adequate faecal occult blood test (FOBt) within 18 weeks of being sent an invitation. Socioeconomic groups will be identified using Index of Multiple Deprivation (IMD) quintile scores
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 socioeconomic variables
Overall study start date
05/11/2012
Overall study end date
02/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women eligible to be screened for bowel cancer in England
2. Aged between 60-74 years
Participant type(s)
Patient
Age group
Senior
Sex
Both
Target number of participants
UK Sample Size: 420000
Participant exclusion criteria
In Intervention 3 (GP endorsed invitation letters) we will only be able to randomise eligible people to receive this intervention if they are registered with practices that have agreed to endorse the BCSP. We estimate that only about 30% of all GP practices in England will consent to their name being used on BCSP invitation letters so the majority of eligible people will receive the usual invitation letters.
Recruitment start date
05/11/2012
Recruitment end date
02/08/2013
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
University College London
London
WC1E 7HB
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Gower Street
London
WC1E 6BT
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research [NIHR] (UK) ref: RP-PG-0609-10106
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2016 | Yes | No | |
| Results article | results | 20/02/2016 | Yes | No |