title: Using Specialist Screening Practitioners (SSPs) to increase uptake of the Bowel Scope (Flexible Sigmoidoscopy) Screening Programme: a study protocol for a feasibility single-stage phase II trial.
abstract: BACKGROUND
  The NHS Bowel Scope Screening (BSS) programme offers men and women aged 55 years a once-only flexible sigmoidoscopy (FS), a test that can help reduce colorectal cancer (CRC) incidence and mortality. However, the benefits of BSS are contingent on uptake. This National Institute for Health Research-funded single-stage phase II trial will test the feasibility of using patient navigation (PN), an intervention that offers support to patients to overcome barriers to healthcare, to increase BSS uptake within a socially deprived area of England.
  
  
  METHODS
  All individuals invited for BSS at South Tyneside NHS Foundation Trust during the 6-month recruitment period will be invited to take part in the study. Consenting participants will be randomised to receive PN or usual care in a 2:1 ratio. PN involves non-attenders receiving a phone call from a Specialist Screening Practitioner (SSP) who will elicit reasons for non-attendance and offer educational, practical, and emotional support as needed. If requested by the patient, another appointment for BSS will then be arranged. We anticipate 30 % of participants will be non-attenders. Using A'Hern single-stage design, with 20 % significance level and 80 % power, at least 35 participants who receive PN need to subsequently attend for PN to be considered worthy of further investigation in a definitive trial. The primary outcome measure will be the number of participants in the PN group who re-book and attend their BSS appointment. A qualitative analysis of the PN transcripts, and interviews with the SSPs, will also be conducted, alongside a quantitative analysis of completed patient-reported experience questionnaires. An economic analysis will calculate the costs of delivering PN.
  
  
  CONCLUSIONS
  This feasibility study will be instrumental in deciding whether to conduct the first definitive trial of PN in BSS in England. If PN is subsequently shown to be cost-effective at increasing uptake of BSS, NHS policies could be modified to implement PN as a standard service. The results will be disseminated in peer-reviewed journals and at scientific conferences.
  
  
  BACKGROUND
  International Standard Randomised Controlled Trial Number, ISRCTN13314752.
authors.affiliation: Cancer Research UK Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College London, London, WC1E 6BT UK.
authors.forename: Lesley M
authors.initials: LM
authors.lastname: McGregor
authors.affiliation: Cancer Research UK Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College London, London, WC1E 6BT UK.
authors.forename: Hanna
authors.initials: H
authors.lastname: Skrobanski
authors.affiliation: Gateshead Health NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Avenue, Sheriff Hill, Gateshead, Tyne and Wear NE9 6SX UK.
authors.forename: Hayley
authors.initials: H
authors.lastname: Miller
authors.affiliation: Gateshead Health NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Avenue, Sheriff Hill, Gateshead, Tyne and Wear NE9 6SX UK.
authors.forename: Mary
authors.initials: M
authors.lastname: Ritchie
authors.affiliation: Patient representative, London, UK.
authors.forename: Lindy
authors.initials: L
authors.lastname: Berkman
authors.affiliation: Department of Applied Health Research, University College London, London, WC1E 6BT UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Morris
authors.affiliation: South Tyneside NHS Foundation Trust, South Tyneside District Hospital, Harton Lane, South Shields, Tyne and Wear NE34 0PL UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Rees
authors.affiliation: Cancer Research UK Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College London, London, WC1E 6BT UK.
authors.forename: Christian
authors.initials: C
authors.lastname: von Wagner
keywords: Bowel scope screening; Colorectal cancer; Non-attenders; Patient navigation