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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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7 November 2022 |
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Main ID: |
ISRCTN52303479 |
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Date of registration:
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08/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Strategies to increase cervical screening uptake at first invitation
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Scientific title:
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STRATEGIes to increase Cervical screening uptake at first invitation: a cluster randomised trial |
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Date of first enrolment:
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01/11/2011 |
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Target sample size:
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9600 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN52303479 |
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Study type:
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Interventional |
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Study design:
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Cluster randomised trial (Screening)
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Phase:
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Not Applicable
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Countries of recruitment
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England
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United Kingdom
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Contacts
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Name:
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Henry
Kitchener |
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Address:
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School of Cancer and Enabling Sciences
University of Manchester
Research Floor
St Mary's Hospital
M13 9WL
Manchester
United Kingdom |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Women aged 25 in Manchester and 20 in Aberdeen who are due to receive their first invitation for cervical screening
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
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervical cancer
Cancer
Malignant neoplasm of cervix uteri
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Intervention(s)
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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.
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Primary Outcome(s)
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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).
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Secondary Outcome(s)
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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
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Secondary ID(s)
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HTA 09/164/01
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Source(s) of Monetary Support
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Health Technology Assessment Programme
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Ethics review
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Status:
Approval date:
Contact:
REC within Greater Manchester via IRAS - approval pending as of 05/08/2011
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/10/2015 |
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URL:
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