Contact information
Type
Public
Primary contact
Dr Christian Von Wagner
ORCID ID
http://orcid.org/0000-0002-7971-0691
Contact details
University College London
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
+44 20 7679 1614
c.wagner@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
32342
Study information
Scientific title
Impact of GP endorsement on the effectiveness of a 12 months’ reminder to improve uptake of bowel scope screening: a randomised controlled trial in a hard-to-reach population
Acronym
Study hypothesis
Adding a GP endorsement to the 12 months' reminder letter will improve uptake of bowel scope screening (BSS) among previous non-participants.
Ethics approval
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, 26/07/2016, ref: 16/YH/0298
Study design
Randomised; Interventional; Design type: Process of Care, Education or Self-Management
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Cancer, Primary sub-specialty: Palliative and Supportive Care; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs, Oral and Gastrointestinal/ Other diseases of the digestive system
Intervention
All screening-eligible adults who have not attended their BSS appointment at St. Mark’s hospital within 12 months’ of their initial invitation will be randomised to receive either the intervention of a GP endorsed reminder letter or a reminder letter without GP endorsement. Because usual care is receiving no reminder 12 months’ after the initial invitation, both groups will technically be receiving an intervention. However, because a standard reminder at twelve months has been shown to be effective at this centre in this way already, this will act as the control against which the added benefit of a GP-endorsement will be compared.
Details of the intervention:
Reminders will be produced by merging the study database with the reminder letter templates and selecting the relevant cases within each of the two documents (i.e. merging GP-endorsed reminder cases with the GP-endorsed reminder letter template). The study materials, which include: the reminder letter, standard information booklet and freepost return envelope will be mailed to the participant in a single envelope. Participant address labels will be produced by mail merging the study database with the participant label template. This process of sending previous non-participants a reminder 12 months’ after their initial will continue until the study sample size (n=1,400) is reached.
Reminders will not offer pre-scheduled appointments, but rather remind participants of the opportunity to book an appointment (self-refer), either by calling the Bowel Cancer Screening Centre Freephone number or by returning an appointment request slip. For recipients who return an appointment request slip, individuals will need to provide a telephone number (either a home or mobile telephone number) so that a member of the St. Mark’s Bowel Cancer Screening centre can contact them to arrange an appointment (both methods of self-referral will require a telephone call between the centre and the recipient to arrange an appointment). Both methods for self-referral will enable participants to choose the day and time of their appointment (factors which have previously been reported as barriers to uptake) (Vernon et al, 1997). After an appointment has been agreed, individuals referring for BSS will be invited to participate in screening as per usual care. Namely, individuals will receive: an appointment confirmation letter shortly after an appointment has been agreed, the bowel preparation kit with instructions for use two weeks before the appointment, a text message reminder one week before the appointment and a telephone call, also one week before the appointment. Appointment attendance will be verified by a member of the direct care team at S.t Mark’s hospital four weeks after the delivery of the reminder letter.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Proportion of individuals attending a Bowel Scope Screening within each group is measured using the attendance at bowel scope screening) and will be collected by a member of the clinical care team at St Mark’s Hospital as accessed from the Bowel Scope Screening database (linked with patient record database).
Secondary outcome measures
Differences in attendance among social and demographic groups is measured using the attendance at bowel scope screening) and will be collected by a member of the clinical care team at St Mark’s Hospital as accessed from the Bowel Scope Screening database (linked with patient record database).
Overall trial start date
04/08/2016
Overall trial end date
01/06/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 56 years at the time they are enrolled in the study
2. Registered with a general practice served by St. Mark’s Hospital
3. Registered with a general practice participating in the study
4. Previously been offered, but not attended, a routine BSS appointment more one year ago at the time of the reminder letter
5. Meet the clinical eligibility criteria for BSS
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 1400; UK Sample Size: 1400
Participant exclusion criteria
1. Individuals who have had their large bowel removed
2. Individuals who have a stoma bag to collect their stool
3. Individuals currently being treated (for example, with steroids) for inflammatory bowel disease in their large bowel (i.e. ulcerative colitis or Crohn’s disease)
4. Individuals who are awaiting heart surgery or who have had heart surgery in the last
Recruitment start date
01/01/2018
Recruitment end date
01/05/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Mark’s Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
Gower Street
London
WC1E 6BT
United Kingdom
+44 20 7679 6639
randd@uclh.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Department of Health
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Upon completion of the analysis, the results of the trial will be published in a peer-reviewed journal and disseminated at conferences in the field. No patient identifiable data will be published and all data anonymised prior to analysis.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Christian von Wagner (c.wagner@ucl.ac.uk)
Intention to publish date
01/09/2018
Participant level data
Available on request
Basic results (scientific)
Publication list