Increasing cervical cancer screening uptake in Yorkshire
| ISRCTN | ISRCTN15082468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15082468 |
| IRAS number | 268639 |
| Secondary identifying numbers | IRAS 268639 |
- Submission date
- 29/11/2021
- Registration date
- 01/12/2021
- Last edited
- 02/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Cervical cancer screening aims to detect abnormal changes in the cervix. If left untreated, these changes can lead to cancer. There are a lot of things that can get in the way of going for cervical cancer screening. Research shows that if people can spot situations that might stop them from getting screened and then link them with solutions to overcome these, they are more likely to go for screening. Research also suggests that people tend to underestimate how many people like them go for screening, and this can put them off attending. The public health service would like to improve screening rates. The aim of this study is to test new materials to see if they increase the number of women going for cervical cancer screening.
Who can participate?
A randomly selected group of patients aged 24.5-65 years invited to take part in cervical cancer screening will also be asked to take part in this study on the specific day the study is taking place.
What does the study involve?
Some participants will receive some extra information through the post which will explain the numbers of people currently attending cervical cancer screening. Other participants may also have been sent a plan to go for screening which they will be asked to fill in. The researchers will then compare screening levels in all the people sent extra materials, 4 months later as well as a group of women sent an information sheet, but no additional materials.
What are the benefits and risks of taking part?
There are no disadvantages except the time that it takes to read the information provided. The benefit is that participants may be helping to improve cervical cancer screening services for their own and others’ future health needs.
Where is the study run from?
University of Leeds and the NHS cervical cancer screening programme (UK)
When is the study starting and how long is it expected to run for?
January 2019 to April 2022
Who is funding the study?
Yorkshire Cancer Research (UK)
Who is the main contact?
Prof. Daryl O’Connor, d.b.oconnor@leeds.ac.uk
Contact information
Public, Scientific
University of Leeds
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
| Phone | via MS Teams |
|---|---|
| D.B.OConnor@leeds.ac.uk |
Study information
| Study design | Randomized controlled trial using a factorial design with four arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Increasing cervical cancer screening uptake in Yorkshire: testing the effectiveness of a behaviour change intervention in deprived and non-deprived populations |
| Study hypothesis | The aim of this research is to test a low-cost behaviour change intervention in the North of England. A randomised controlled trial will test two interventions individually and combined: (a) Implementation intention based intervention, (b) a motivational based intervention, (c) both these interventions combined, (d) usual care control. |
| Ethics approval(s) | 1. Approved 12/10/2020, The Cervical Screening Research Advisory Committee (PHE Screening, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK; +44 (0)20 3682 0890; screening.research@phe.gov.uk) ref: CSPRAC_0050 2. Approved 25/03/2021, North East -Newcastle & North Tyneside 1 Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8139, +44 (0)207 104 8285, +44 (0)203 443 6294; newcastlenorthtyneside1.rec@hra.nhs.uk), REC ref: 21/NE/0033 3. Approved 30/03/2021, NHS Confidentiality Advisory Group (CAG) (2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 104 8100; cag@hra.nhs.uk), ref: 21/CAG/0021 4. Approved 19/05/2021, Public Health England Office of Data Release Office for Data Release (Public Health England, Wellington House, 133 – 155 Waterloo Road, London, SE1 8UG, UK; +44 (0) 20 7654 8030; odr@phe.gov.uk) ref: CSPRAC_050 (ODR1920_239) 5. Approved 20/07/2021, NHS England DRAB Corporate Information Governance (NHS England and Improvement, Quarry House, Quarry Hill, Leeds, LS2 7UE, UK; Tel: not available; England.pdrm@nhs.net) ref: CSPRAC_050 (ODR1920_239) |
| Condition | Cervical cancer screening |
| Intervention | Randomisation will be at the individual level in blocks of four: 1. Implementation intention only 2. Motivational intervention only 3. Combined implementation intention and motivational intervention 4. Usual care control group Participants will receive the intervention according to the arm that they are allocated to. The implementation intervention will use a Volitional Help Sheet (VHS) which enables participants to form ‘if-then’ plans by connecting barriers associated with screening with potential solutions that could be applied if the barriers are encountered. The content of these barriers and solutions have been identified from previous research and through free text responses on an online survey and qualitative interviews which have identified a wide range of barriers and facilitators. To ensure the intervention is tailored to each participant given they will choose the situation and solutions that match their own needs, thereby, accounting for differences in terms of age and deprivation. The basis of the motivational intervention is a Social Norm Approach (SNA) based on social norms theory. Social norms theory suggests that people falsely perceive the attitudes and/or behaviours of important others to be different from their own there is a tendency for individuals to underestimate the extent to which their peers engage in health behaviours which may discourage performance of the behaviour. The motivational intervention will provide accurate information about the percentage of women currently engaging in cervical cancer screening. The combined intervention includes both the motivational and volitional interventions being sent to participants. |
| Intervention type | Behavioural |
| Primary outcome measure | Cervical cancer screening uptake as indicated by participant screening records at 16-week follow-up |
| Secondary outcome measures | 1. Age of participants on the date of the intervention mailing 2. Socioeconomic status as indicated by the index of multiple deprivation quintile derived from the participant's postcode on the date of the intervention mailing |
| Overall study start date | 01/01/2019 |
| Overall study end date | 06/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 16000 |
| Participant inclusion criteria | 1. Participants eligible for cervical cancer screening 2. Aged 24.5 - 65 years 3. From Clinical Commissioning Groups (CCGs) based in Yorkshire, Humber and North East regions |
| Participant exclusion criteria | 1. Individuals not eligible for cervical cancer screening 2. Individuals outside of the 24.5 - 65 year age limits 3. Located outside of the eligible CCGs 4. Those opting out of their data being used for research (national data opt-out) |
| Recruitment start date | 09/12/2021 |
| Recruitment end date | 09/12/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds
LS2 9JT
United Kingdom
Sponsor information
University/education
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
| Phone | +44 (0)113 343 4897 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- YCR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Study results will be written up and published when data are available. Additional documents are not available and will not be available online, please use the contact details to request. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to study ethics and data protection, raw data is not able to be shared by the study authors. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
02/07/2024: The study contact was updated.
29/11/2021: Trial's existence confirmed by the North East -Newcastle & North Tyneside 1 Research Ethics Committee.
