Condition category
Cancer
Date applied
30/04/2018
Date assigned
03/05/2018
Last edited
03/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Bowel cancer is the second most common cause of cancer-related deaths in England. Bowel scope screening (BSS) can prevent bowel cancer by removing pre-cancerous growths within the bowel before they become cancerous. Previous research has shown that BSS can lower a person’s risk of getting bowel cancer by a third and their risk of dying from bowel cancer by half. The NHS in England now offers BSS to 55 year olds registered with a general practice (GP), but uptake is low, particularly in more deprived areas. The aim of this study is to find out whether GP practice based interventions can increase uptake of BSS in Hull and other parts of Yorkshire.

Who can participate?
People aged 55 due to receive their NHS BSS invitation (identified through GPs)

What does the study involve?
Participants are randomly allocated to one of three groups:
1. Usual care: no contact from GPs
2. Primer and self-referral letter: A letter advising of the future delivery of a BSS invitation is sent by the participant’s GP, along with a locally tailored leaflet explaining the test. If the practice receives notice that an individual did not attend their appointment, a letter highlighting the self-referral process is sent.
3. Primer and patient navigation: As above, a letter and leaflet are sent ahead of the NHS BSS invitation. If the practice receives notice that an individual did not attend their appointment, a call to the participant is made to identify and address personal barriers to uptake and, if appropriate, help arrange a new appointment. If no telephone contact is possible, a self-referral letter is sent.
Screening attendance is monitored and compared between the groups.

What are the possible benefits and risks of participating?
Patients may become more informed about what BSS is and attend their BSS appointment, helping to reduce their risk of bowel cancer. These interventions may increase BSS uptake and reduce the number of bowel cancers diagnosed in Yorkshire, and involve no risk to the patients.

Where is the study run from?
1. The Bridge Group Practice
2. Dr Raganath Practice
3. James Alexander Family Practice
4. Riverside Medical Centre
5. Dr AK Choudhary and Dr SR Danda practice
6. Kingston Medical Group
7. The Quays
8. Goodheart surgery
9. Cottingham Medical Centre
10. Greengates Medical Group
11. Beverley and Molescroft surgery
12. Kingston Medical Health
13. Wolseley Medical Centre
14. Hedon Group Practice

When is the study starting and how long is it expected to run for?
April 2017 to September 2019

Who is funding the study?
Yorkshire Cancer Research (UK)

Who is the main contact?
Dr Lesley McGregor
l.mcgregor@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lesley McGregor

ORCID ID

http://orcid.org/0000-0002-7093-1391

Contact details

Room 207
1-19 Torrington Place
University College London
London
WC1E 7HB
United Kingdom
+44 (0)20 7679 8268
l.mcgregor@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35266

Study information

Scientific title

Using primary care to increase uptake of the Bowel Scope Screening Programme in Yorkshire: evaluating paper and telephone based interventions

Acronym

Study hypothesis

Bowel cancer is the second most common cause of cancer-related deaths in England. Bowel scope screening (BSS) can prevent bowel cancer by removing pre-cancerous growths within the bowel before they become cancerous. Previous research has shown that BSS can lower a person’s risk of getting bowel cancer by a third and their risk of dying from bowel cancer by half. The NHS in England now offers BSS to 55 year olds registered with a general practice (GP); however, uptake is low, particularly within more deprived areas. For this study, the aim is to answer the question: Can GP practice based interventions help increase uptake of BSS in Hull and other parts of Yorkshire?

Ethics approval

London – Harrow Research Ethics Committee, 24/04/2018, ref: 17/LO/1723

Study design

Randomised; Interventional; Design type: Screening, Process of Care, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Specialty: Primary Care, Primary sub-specialty: Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs

Intervention

Randomisation
The UCL research team will supply each GP practice with a template of the ‘study database’, which will contain a pre-set randomisation list. Participants added to the database will therefore be assigned to one of three study groups below. The pre-set randomisation list will be generated using block randomisation to ensure each practice has a similar number of patients within each study group. Each person added to the study database will have their address checked against other individuals within the study database. If someone resides at an address that has already been entered into the study database, they will automatically be given the same study group as the first person at that address. This will make sure people living at the same address receive the same intervention, thereby reducing the opportunity for contamination.

Phase 1: Randomised Controlled Trial
Over a 6 month period, individuals due to receive their NHS BSS invitation (identified through GPs) will be randomly be assigned to one of three groups with attendance monitored and compared between groups:
1. Usual care: no contact from GPs.
2. Primer and self-referral letter (up to 10 minutes to read and respond to): A letter advising of the future delivery of a BSS invitation will be sent by the individual’s GP, along with a locally tailored leaflet explaining the test. If the practice receives notice that an individual did not attend their appointment, a letter highlighting the self-referral process will be sent.
3. Primer and patient navigation call (lasting up to 45 minutes): As above, a letter and leaflet will be sent ahead of the NHS BSS invitation. If the practice receives notice that an individual did not attend their appointment, a call to the individual will be made. This call will aim to identify and address personal barriers to uptake and, if appropriate, help arrange a new appointment. If no telephone contact is possible, a self-referral letter will be sent.

Phase 2: Process Evaluation
The GP practice will send a letter to a selection of patients who received the interventions in the RCT, inviting them to contact the UCL researchers if they would like to take part in a telephone interview (conducted by UCL researchers). An email with a link to the online survey, with an attached information sheet, from the UCL researchers will be sent to all relevant GP practice staff. A reminder will be sent after two weeks.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The proportion of individuals attending a bowel scope screening appointment within each study group. Data on the attendance status of each person will be obtained at the end of the study, 12 weeks after the distribution of the final self-referral reminder letter/patient navigation call. The data will be obtained by NHS Digital, who will extract the ‘Date of attended appointment’ of each person from the NHS Bowel Cancer Screening System using each patient’s NHS Number. The NHS numbers will be removed from the dataset prior to transfer and analysis by the UCL research team.

Secondary outcome measures

1. The proportion of individuals attending screening within each group before and after the delivery of non-participant interventions (i.e. uptake within each group before and after the delivery of the self-referral reminder letter/patient navigation telephone call). Data on the attendance status of each person will be obtained immediately before the delivery of non-participant interventions and again 12 weeks after the distribution of the final self-referral reminder/patient navigation telephone call. This information will be obtained by the GP Practice and NHS Digital, who will record the ‘Hub letter outcome’ (which reports attendance at the appointment offered by the NHS Bowel Cancer Screening Programme and is used to determine which individuals in the intervention groups should receive non-participant interventions) and ‘Date of attended appointment’ respectively. Comparisons between the interventions groups (Groups 2 and 3) and the control (Group 1), immediately before the delivery of the non-participant interventions, will then be used to determine the impact of the primer letter on uptake. Comparisons within groups, immediately before the delivery of non-participant interventions and 12 weeks after the delivery of the final self-referral reminder letter/patient navigation call, will conversely be used to assess the impact of the self-referral reminder letter and patient navigation call on uptake. Again, all data will be anonymised prior to analysis by the UCL research team.
2. The demographic composition of individuals who respond to self-referral reminder letters and patient navigation telephone calls. Data on the sex and ethnicity of each person will be added to the dataset using data within the GP Clinical System. Data on the area-level deprivation of each person’s home address will also be added to the dataset. This will also be done by the GP practice, who will convert the postcode of the individual’s home address (also available on the GP clinical system) into a score on the 2015 Index of Multiple Deprivation (IMD). These data will then be used to assess the demographic composition of individuals who respond to the self-referral reminder letter and patient navigation telephone call.
3. The proportion of individuals attending follow-up colonoscopy within each group. Data on the offer and uptake of follow-up colonoscopy will be added to the dataset using data available on the NHS bowel cancer screening system. The proportion of individuals attending follow-up colonoscopy within each group will then be assessed to determine whether the interventions had any impact on attendance at follow-up colonoscopy.
4. The cost-effectiveness of the interventions to improve bowel scope screening uptake. Pre-existing data on lifetime costs and benefits will be used in the analysis.
5. The acceptability of interventions to bowel scope screening invitees and GP practices. At the end of the study, the trialists will interview a selection of individuals who received the interventions to ask about their views on the materials received and their possible influence on their decision making. They will also seek to obtain the views of staff members from the GP practices involved in the RCT using an online survey.

Overall trial start date

01/04/2017

Overall trial end date

30/09/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Individuals (aged 55 years and 1 month) registered with a participating GP practice served by the Bowel Cancer Screening Centre in Hull

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2000; UK Sample Size: 2000

Participant exclusion criteria

Individuals will be excluded if:
1. They do not meet the clinical eligibility criteria for BSS (i.e. they have had their large bowel removed; they have a stoma bag to collect their stool; they are currently being treated for inflammatory bowel disease; they are awaiting heart surgery or have had heart surgery in the last three months)
2. They are registered on the clinical system as being a type 2 objector/opt out (i.e. have indicated that their confidential information cannot be shared by NHS Digital for any purposes beyond their own immediate care)
3. They are known to be receiving palliative care
4. They have been diagnosed with cancer (of any type) in the past 12 months
Further exclusions will apply at the GP practice’s discretion

Recruitment start date

04/06/2018

Recruitment end date

29/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Bridge Group Practice
Hull
HU6 9BX

Trial participating centre

Dr Raganath Practice
Hull
-

Trial participating centre

James Alexander Family Practice
Hull
HU7 4DW

Trial participating centre

Riverside Medical Centre
Hull
HU3 2RA

Trial participating centre

Dr AK Choudhary and Dr SR Danda practice
Hull
HU7 4DW

Trial participating centre

Kingston Medical Group
Hull
HU3 1TY

Trial participating centre

The Quays Medical Centre
Hull
HU1 3SA

Trial participating centre

Goodheart Surgery
Hull
HU7 4DW

Trial participating centre

Cottingham Medical Centre
Cottingham
HU16 4AJ

Trial participating centre

Greengates Medical Group
Beverley
HU17 0HB

Trial participating centre

Beverley and Molescroft Surgery
Beverley
HU17 9GQ

Trial participating centre

Kingston Medical Health
Hull
HU3 5QE

Trial participating centre

Wolseley Medical Centre
Hull
HU3 1DS

Trial participating centre

Hedon Group Practice
Hull
HU12 8JD

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 (0)20 3447 5557
Rand.D@uclh.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Yorkshire Cancer Research; Grant Codes: UCL407

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol will be published in a peer-reviewed journal. Planned publication of the results in a high-impact peer reviewed journal and presentation at academic conferences within one year of the overall trial end date.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/09/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes