Strategies to increase cervical screening uptake at first invitation
| ISRCTN | ISRCTN52303479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52303479 |
| Secondary identifying numbers | HTA 09/164/01 |
- Submission date
- 04/08/2011
- Registration date
- 08/08/2011
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Henry Kitchener
Scientific
Scientific
School of Cancer and Enabling Sciences
University of Manchester
Research Floor
St Mary's Hospital
Manchester
M13 9WL
United Kingdom
Study information
| Study design | Cluster randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | STRATEGIes to increase Cervical screening uptake at first invitation: a cluster randomised trial |
| Study acronym | STRATEGIC |
| Study objectives | 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(s) | REC within Greater Manchester via IRAS - approval pending as of 05/08/2011 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2011 |
| Completion date | 31/10/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 9,600 |
| Total final enrolment | 10126 |
| Key inclusion criteria | Women aged 25 in Manchester and 20 in Aberdeen who are due to receive their first invitation for cervical screening |
| Key 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 |
| Date of first enrolment | 01/11/2011 |
| Date of final enrolment | 31/10/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Manchester
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
c/o Professor Nalin Thakker
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Website | http://www.manchester.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2016 | Yes | No | |
| Results article | results | 01/06/2018 | 27/08/2019 | Yes | No |
| Plain English results | 25/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link added.
27/08/2019: Publication reference and total final enrolment added.
19/09/2016: Publication reference added.
