A feasibility study of patient navigation in bowel scope screening

ISRCTN	ISRCTN13314752
DOI	https://doi.org/10.1186/ISRCTN13314752
Secondary identifying numbers	18256

Submission date: 01/07/2015
Registration date: 01/07/2015
Last edited: 28/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-a-way-to-support-people-as-they-make-a-decision-to-have-bowel-scope-screening

Contact information

Dr Christian Von Wagner
Public

University College London
Gower Street
London
WC1E 6BT
United Kingdom

Study information

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
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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
Study objectives	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)
Health condition(s) or problem(s) studied	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
Completion date	19/11/2015

Eligibility

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
Key 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
Key exclusion criteria	Patients invited will be identified as eligible for bowel scope screening by the Bowel Cancer Screening Programme (BCSP)
Date of first enrolment	19/05/2015
Date of final enrolment	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

University College London
University/education

UCL Biomedicine Research & Development Unit, Maple House, 149 Tottenham Court Road
London
W1T 7NF
England
United Kingdom

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

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
Location: United Kingdom

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	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

Editorial Notes

28/05/2020: Link to basic results added to Results (plain English).
04/03/2020: Publication reference and total final enrolment number added.
14/09/2016: Publication reference added.
13/04/2016: Ethics approval information added.