Condition category
Cancer
Date applied
30/01/2017
Date assigned
30/01/2017
Last edited
16/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/10/2017: Internal review. 15/09/2017: Internal review. 26/07/2017: The following changes were made to the trial record: 1. The recruitment start date was changed from 01/06/2017 to 01/01/2018. 2. The recruitment end date was changed from 31/07/2017 to 01/05/2018. 3. The overall trial end date was changed from 21/11/2017 to 01/06/2018.