GP Endorsement of Bowel Screening

ISRCTN	ISRCTN86784060
DOI	https://doi.org/10.1186/ISRCTN86784060
Protocol serial number	10854
Sponsor	University of Birmingham (UK)
Funder	NIHR School for Primary Care Research

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Mrs Sue Clifford
Scientific

Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	S.Clifford@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised interventional process of care
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluating the effectiveness of GP endorsement in increasing participation in the NHS Bowel Cancer Screening Programme: A feasibility trial
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	4380
Key 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
Key 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.
Date of first enrolment	26/09/2011
Date of final enrolment	30/01/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Primary Care & General Practice

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.