GP Endorsement of Bowel Screening
| ISRCTN | ISRCTN86784060 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86784060 |
| Secondary identifying numbers | 10854 |
- Submission date
- 29/09/2011
- Registration date
- 29/09/2011
- Last edited
- 06/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims:
Colorectal (bowel) cancer is the second leading cause of cancer death in the UK, and costs the National Health Service (NHS) more than £300 million a year in treatment costs. Patient survival could be increased and, costs very much reduced, if patients with bowel cancer received their diagnosis earlier, allowing treatment to begin earlier. The NHS Bowel Cancer Screening Programme (NHSBCSP) was introduced in England in 2006, and aims to screen men and women aged between 60 to 74 years of age for bowel cancer every two years using the faecal occult blood test (FOBt). Initial studies have shown that bowel screening is effective, but the number of patients who participate in screening have been quite low, with only around half of all the people who are invited to participate returning their FOBt kit.
The success of the NHSBCSP relies on a high number of patients participating, and the development of new ways to improve the number participating after they are invited to participate.
The main aim of the study is to assess how effective a GP reminder and additional FOBt kit are on increasing the number who participate in bowel cancer screening, when they have not participated following a previous invitation.
Who can participate?
All adults eligible for bowel screening (aged between 60 to 74 years old). These were patients at a participating general practice in the West Midlands, where the screening rate is less than 50%. These patients had been invited to participate in bowel screening but had not returned their FOBt within 13 weeks of initial invitation by the Midlands and North West Bowel Cancer Screening Hub.
What does the study involve?
We will randomly allocate the participants to one of two groups:
1. GP reminder to participate in bowel screening and additional FOBt kit, OR
2. No additional contact
We compared how may people participated in bowel screening after 13 weeks. This was measured by the number of FOBt kits that were returned to the bowel screening hub by patients in each group. This allowed us to assess if the GP reminder to participate in bowel screening and additional FOBt kit was successful in increasing the participation in bowel screening. A small interview was carried out with some patients who received the GP reminder who returned a FOBt kit.
What are the possible benefits and risks of participating?
There were no direct benefits to the patients who participated, but their participation will allow us to better understand why a person decides to take part in bowel screening, and what may put some people off participating. The findings will be used to help to identify ways to improve the NHS Bowel Cancer Screening Programme, so that future patients can benefit from a more effective screening service. There are no known risks associated with participating in this study.
Where is the study run from?
From the Department of Primary Care Clinical Sciences, at the University of Birmingham, in collaboration with the Department of Primary Healthcare at University of Oxford, and the Midlands and North West Bowel Cancer Screening Hub.
When is the study starting and how long is it expected to run for?
The study began in October 2011 and recruitment continued for approximately six months. The study ended in September 2012.
Who is funding the study?
National Institute for Health Research (NIHR) - School for Primary Care Research
Who is the main contact?
Mrs Sue Clifford
s.clifford@bham.ac.uk
Contact information
Scientific
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
| S.Clifford@bham.ac.uk |
Study information
| Study design | Randomised interventional process of care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | Evaluating the effectiveness of GP endorsement in increasing participation in the NHS Bowel Cancer Screening Programme: A feasibility trial |
| Study hypothesis | This feasibility study will comprise a two-armed randomised controlled trial to evaluate the effectiveness of a GP endorsed reminder in improving patient participation in the NHS Bowel Cancer Screening Programme (NHS BC SP), and a qualitative research study to establish the perceived importance of different components of this complex intervention. |
| Ethics approval(s) | First MREC, 12 July 2011, ref: 11/WM/0086 |
| Condition | Bowel Cancer |
| Intervention | The study population will be adults aged 60 to 74 who have been invited to participate in bowel screening but who have not returned their Faecal Occult Blood Test (FOBt) kit within the 13 week screening episode recorded by the Midlands and North West Bowel Cancer Screening Hub. The Hub will identify general practices with a patient uptake of bowel screening less than 50%. Depending on the number of non-responders at each practice, up to 20 practices will be recruited, and approximately 4,000 people randomised in equal numbers to either the intervention (GP letter and duplicate FOBt kit) or control (no additional contact) arms of the trial. |
| Intervention type | Other |
| Primary outcome measure | The difference in the uptake rate of FOBt screening for bowel cancer (i.e. completion and return of FOBt kit) between the intervention and control groups at 13 weeks after the GP endorsed reminder and duplicate FOBt kit are sent. |
| Secondary outcome measures | 1. Subgroup analyses of uptake by gender, age and deprivation 2. The development and validation of methods for collecting data on intervention costs 3. Qualitative work (30-40 semi-structured interviews) will be undertaken with individuals in the intervention arm who return a FOBt kit. This will investigate the relative importance of the duplicate FOBt kit, reminder to participate, and GP endorsement of that reminder in contributing to individuals decisions to participate in screening. If the feasibility work demonstrates a significant increase in uptake of FOBt screening in individuals receiving the intervention, a future definitive trial can be designed and appropriately powered. |
| Overall study start date | 26/09/2011 |
| Overall study end date | 30/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 4380; UK Sample Size: 4380; Description: Patients will be randomised to the intervention or control arms of the study in the ratio of 1:1 |
| Participant inclusion criteria | 1. Adults aged 60 to 74 2. Non-responders to previous invitation to participate in NHS Bowel Cancer Screening Programme 3. Target Gender: Male & Female |
| Participant exclusion criteria | 1. Recently undergone an investigation and/or are currently under surveillance. 2. Moved outside age range for screening. 3. Have contacted Hub requesting no further contact. |
| Recruitment start date | 26/09/2011 |
| Recruitment end date | 30/01/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
B15 2TT
United Kingdom
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 3344 |
|---|---|
| no@email.com | |
| Website | http://www.birmingham.ac.uk/ |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | study protocol | 20/02/2012 | Yes | No |
Editorial Notes
06/11/2019: Internal review.
30/08/2018: Dr Sarah Damery confirmed that the trial results have not been published.
29/08/2018: No publications found, verifying study status with principal investigator.
