Condition category
Digestive System
Date applied
01/07/2015
Date assigned
01/07/2015
Last edited
14/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Public

Primary contact

Dr Christian Von Wagner

ORCID ID

Contact details

University College London
Gower Street
London
WC1E 6BT
United Kingdom

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

19/05/2015

Overall trial end date

19/11/2015

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 384; UK Sample Size: 384

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-016-0093-8

Publication citations

Additional files

Editorial Notes

14/09/2016: Publication reference added. 13/04/2016: Ethics approval information added.