Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
18256
Study information
Scientific title
Using specialist screening practitioners (SSPs) to increase uptake of the bowel scope screening programme: a feasibility study of patient navigation within South Tyneside NHS Foundation Trust
Acronym
Study hypothesis
Bowel cancer prevention and early diagnosis is an NHS priority. Bowel Scope Screening (BSS) has recently been introduced to the NHS Bowel Cancer Screening Programme in an attempt to reduce future bowel cancer incidence. BSS involves a Flexible Sigmoidoscopy (FS), a procedure that can prevent bowel cancer by finding and removing growths in the bowel before they turn into cancer. BSS is currently offered as a one-off test to men and women aged 55 years. However, the success of any screening programme is dependent on uptake. A recent pathfinder programme of BSS in England found uptake to be as low as 28%. Patient navigation (PN) is an intervention that offers individual support to patients to help them overcome their barriers to screening. In this study, PN will involve Specialist Screening Practitioners (SSPs) from the South of Tyne ScreeningCentre calling people who either fail to confirm or attend their BSS appointment. SSPs will encourage discussion of the individual’s barriers to screening attendance and will offer suitable solutions and support. SSPs will be trained to communicate the aims, benefits and risks of BSS, to ensure that people make an informed choice about whether participation is right for them. To assess whether PN is feasible in increasing the uptake of BSS, non-attenders will be randomly assigned to one of two groups: usual care or usual care with PN. We will monitor the number of people who participate in BSS after PN and the patient experience of this service. We will also conduct qualitative interviews with SSPs to evaluate the impact that PN has on their workload. A feasibility study is very important in this context because non-attenders are difficult to involve in research studies. If PN is effective and acceptable, we will apply for funding for a larger, multi-centre trial.
Ethics approval(s)
National Research Ethics Service Committee London – Bloomsbury, 30/01/2015, ref: 14 LO 2308)
Study design
Randomised; Interventional; Design type: Process of Care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Gastroenterology; Subtopic: Gastroenterology; Disease: All Gastroenterology
Intervention
Patient Navigation (PN), an intervention that offers individual support to patients to help them overcome their barriers to screening. In this study, PN will involve specialist screening practitioners (SSPs) from the South of Tyne Screening Centre calling people who either fail to confirm or attend their BSS appointment. SSPs will encourage discussion of the individual’s barriers to screening attendance and will offer suitable solutions and support. SSPs will be trained to communicate the aims, benefits and risks of BSS.
Intervention type
Other
Primary outcome measure
Uptake of Bowel Scope Screening; Timepoint(s): when the outcome data is extracted for the UCL team to analyse
Secondary outcome measures
N/A
Overall study start date
19/05/2015
Overall study end date
19/11/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. As part of the NHS Bowel Scope Screening Programme (BCSP), participants need to be 55 years (and up to 2 months) during the recruitment period, and live in the South of Tyne area served by the South Tyneside NHS Trust
2. Target Gender: Male & Female
3. Aged at least 55
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Planned Sample Size: 384; UK Sample Size: 384
Total final enrolment
152
Participant exclusion criteria
Patients invited will be identified as eligible for bowel scope screening by the Bowel Cancer Screening Programme (BCSP)
Recruitment start date
19/05/2015
Recruitment end date
19/11/2015
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
University College London
Gower Street
London
WC1E 6BT
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
UCL Biomedicine Research & Development Unit
Maple House
149 Tottenham Court Road
London
W1T 7NF
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/09/2016 | Yes | No | |
| Results article | results | 15/02/2019 | 04/03/2020 | Yes | No |
| Plain English results | 28/05/2020 | No | Yes |