Condition category
Cancer
Date applied
04/08/2011
Date assigned
08/08/2011
Last edited
19/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Henry Kitchener

ORCID ID

Contact details

School of Cancer and Enabling Sciences
University of Manchester
Research Floor
St Mary's Hospital
Manchester
M13 9WL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 09/164/01

Study information

Scientific title

STRATEGIes to increase Cervical screening uptake at first invitation: a cluster randomised trial

Acronym

STRATEGIC

Study hypothesis

How effective, and cost effective, are complex interventions designed to increase receptivity to, and uptake of, cervical screening in women aged 25 who are receiving their first invitation to the NHS Cervical Screening Programme?

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0916401
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0005/55193/PRO-09-164-01.pdf

Ethics approval

REC within Greater Manchester via IRAS - approval pending as of 05/08/2011

Study design

Cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Cervical cancer

Intervention

1. Pre-leaflet arm (Phase 1) - Surgeries will be cluster randomised with women either receiving the pre-leaflet in combination with a standard invitation letter or the standard invitation letter alone.
2. Internet booking arm (Phase 1, Manchester only) - Surgeries will be cluster randomised to women either receiving a standard invitation and reminder letter which gives them the opportunity to book online or the standard invitation and reminder letter alone.
3. Self-sampling arm (Phase 2) - Surgeries will be cluster randomised to women receiving the offer of a self-sampling test compared with standard practice of a reminder letter.
4. Nurse navigator arm (Phase 2) - Surgeries will be cluster randomised to women receiving the offer of speaking to a specialist nurse compared with standard practice of a reminder letter.
5. Timed appointment arm (Phase 2) - Surgeries will be cluster randomised to women receiving a timed appointment from their general practitioner (GP) compared with standard practice of a reminder letter.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The uptake of cervical screening:
1.1. In response to the pre-leaflet (phase 1)
1.2. In response to the offer of each of the interventions (nurse navigator, self-sampling, timed appointments) (phase 2)
2. The uptake of internet booking (phase 1)

Measured at 3, 12 and 30 months after the date the woman become eligible for cervical screening (i.e. her 25th or 20th birthday).

Secondary outcome measures

1. The differences between outcomes in Aberdeen between vaccinated and unvaccinated women
2. The differences between Aberdeen and Manchester
3. Cost-effectiveness of the interventions, individually and as packages of interventions

Overall trial start date

01/11/2011

Overall trial end date

31/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 25 in Manchester and 20 in Aberdeen who are due to receive their first invitation for cervical screening

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

9,600

Participant exclusion criteria

1. Women who are not aged 25 (20 in Aberdeen) and receiving their first invitation for screening will not be eligible to participate
2. Women who are pregnant
3. Women who do not have a cervix
4. Women who have made an informed decision not to participate in the cervical screening programme

Recruitment start date

01/11/2011

Recruitment end date

31/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Professor Nalin Thakker
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

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 results in: http://www.ncbi.nlm.nih.gov/pubmed/27632816

Publication citations

Additional files

Editorial Notes

19/09/2016: Publication reference added.