HPV-Related Cervical CarcinomaVRCSNCT04970394
An Observational Study of GP Verbal Reminders Upon Cervical Screening
An observational study of HPV-Related Cervical Carcinoma and Physician-Patient Relations, run by Dr. Faizan Awan at 1 site in United Kingdom.
Trial summary
Cervical cancer screening is offered to all women in the United Kingdom (UK) between the ages of 24.5 and 64 years of age. The majority of screening is performed in primary care and the rate remains stubbornly below 80%, despite an automated national invitation system. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV-Related Cervical Carcinoma, Physician-Patient Relations
- What is being tested?
- Cervical Screening Reminder
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 724 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2017to 3 Mar 2021
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients registered at the Gill Medical Centre, who have a cervix, are eligible for cervical screening and have been non responders to the automated national invitation. These patients are opportunistically recruited when they are consulted by the principal investigator.
Who may be able to join
- Registered patient with a cervix
- Non responder to cervical screening invitation
Who cannot join
- Incorrectly reminded i. Coding errors ii. Human error
- Temporary patients i. Did not remain registered for minimum of 6 months following intervention
- Screening refusal
- Inappropriate to include i. Terminal illness ii. Prolonged hospitalisation iii. Death due to non-cervical cancer attributable cause
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Gill Medical Centre
Salford, Greater Manchester, M28 3DR
About this study
Official title: Three-year Prospective Cohort Study of the Effectiveness of Physician Reminders on Cervical Screening Uptake Amongst Non Responders in a UK Primary Care Setting
Cervical cancer screening is offered to all women in the United Kingdom (UK) between the ages of 24.5 and 64 years of age. The majority of screening is performed in primary care and the rate remains stubbornly below 80%, despite an automated national invitation system. This study is designed to assess the effectiveness of a physician invitation during a telephone or face-to-face primary care appointment upon non responders of automated invitations, to increase the uptake of cervical screening.
Read the detailed description
It is estimated that between 800 and 2,000 deaths a year are now prevented due to the effectiveness of the UK's national cervical screening programme and mortality rates have dropped by over 75% since the 1970s. These statistics corroborate the importance of the screening programme in reducing mortality from cervical cancer. Cervical screening rates in the UK remains stubbornly below 80% and interventions are needed to attract the 20% who are missing out on screening. This prospective observational study is designed to measure the impact of a physician intervention in a usual healthcare environment, amongst a heterogeneous patient population to yield replicable real-world results. The intervention arm will receive a physician intervention to inform them of their overdue screening status, remind them of the importance of cervical screening and guide them to book a screening appointment. The screening rate in the intervention arm will be compared to a control made up of patients seen by other clinicians and receiving unstructured reminders. The results will assist physicians in deciding whether a structured intervention is anymore effective than the unstructured advice currently given at improving screening rates in the non responder population.
- Being tested
- Cervical Screening Reminder
- Keywords
- Cervical Screening, Primary health care, Physician intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Screening ReminderBehavioural
Verbal reminder and if seen face-to-face, a written appointment booking slip.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | The principal investigator reviews the medical notes of all individuals they consult over a period of three years to check if they are non responders. If confirmed as non responder, they receive a three-step verbal intervention:
1. "Your cervical cancer screening is now overdue."
2. "The test is easy to perform and saves thousands of lives from cervical cancer every year."
3. "Should we book an appointment for cervical screening now so that you make sure you have it done?"
Those who are seen face-to-face receive a fourth intervention:
4. An appointment slip is given to the patient to hand to the receptionist. This includes the patient's name and the comment, "book an appointment with practice nurse for cervical screening". Receives: Behavioral: Cervical Screening Reminder | |
| Control | The control group receives standard unstructured reminders regarding their overdue status from any of the 6 other clinicians during appointments and / or reminder letters from the administration team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of Cervical Screening
The number of patients who undergo cervical screening
Measured: Up to 1 year post intervention
Secondary outcomes (1)
Time to book screening
Length of time taken to undergo screening following intervention
Measured: Up to 1 year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Mar 2017
- Primary completion29 Feb 2020
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV-Related Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 724 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Dr. Faizan Awan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Faizan Awan, The Gill Medical Centre
- Investigators
- Faizan A Awan, MBChB MRCGP, Principal investigator, The Gill Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970394
- Sponsor's protocol ID
- 298846
- Acronym
- VRCS
- Status last verified
- Aug 2021
- First submitted
- 11 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared with researchers who confirm the purpose of their request and are affiliated with a research organisation.
Publications
Everett T, Bryant A, Griffin MF, Martin-Hirsch PP, Forbes CA, Jepson RG. Interventions targeted at women to encourage the uptake of cervical screening. Cochrane Database Syst Rev. 2011 May 11;2011(5):CD002834. doi: 10.1002/14651858.CD002834.pub2.
PubMed 21563135
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-year Prospective Cohort Study of the Effectiveness of Physician Reminders on Cervical Screening Uptake Amongst Non Responders in a UK Primary Care Setting
- ClinicalTrials.gov ID
- NCT04970394
- Acronym / sponsor ID
- VRCS / 298846
- Keywords
- Cervical Screening, Primary health care, Physician intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- Dr. Faizan AwanUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervical cancer screening is offered to all women in the United Kingdom (UK) between the ages of 24.5 and 64 years of age. The majority of screening is performed in primary care and the rate remains stubbornly below 80%, despite an automated national invitation system. This study is designed to assess the effectiveness of a physician invitation during a telephone or face-to-face primary care appointment upon non responders of automated invitations, to increase the uptake of cervical screening.
Detailed description
It is estimated that between 800 and 2,000 deaths a year are now prevented due to the effectiveness of the UK's national cervical screening programme and mortality rates have dropped by over 75% since the 1970s. These statistics corroborate the importance of the screening programme in reducing mortality from cervical cancer. Cervical screening rates in the UK remains stubbornly below 80% and interventions are needed to attract the 20% who are missing out on screening. This prospective observational study is designed to measure the impact of a physician intervention in a usual healthcare environment, amongst a heterogeneous patient population to yield replicable real-world results. The intervention arm will receive a physician intervention to inform them of their overdue screening status, remind them of the importance of cervical screening and guide them to book a screening appointment. The screening rate in the intervention arm will be compared to a control made up of patients seen by other clinicians and receiving unstructured reminders. The results will assist physicians in deciding whether a structured intervention is anymore effective than the unstructured advice currently given at improving screening rates in the non responder population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: Cervical Screening ReminderThe principal investigator reviews the medical notes of all individuals they consult over a period of three years to check if they are non responders. If confirmed as non responder, they receive a three-step verbal intervention: 1. "Your cervical cancer screening is now overdue." 2. "The test is easy to perform and saves thousands of lives from cervical cancer every year." 3. "Should we book an appointment for cervical screening now so that you make sure you have it done?" Those who are seen face-to-face receive a fourth intervention: 4. An appointment slip is given to the patient to hand to the receptionist. This includes the patient's name and the comment, "book an appointment with practice nurse for cervical screening". |
| Control | – | –The control group receives standard unstructured reminders regarding their overdue status from any of the 6 other clinicians during appointments and / or reminder letters from the administration team. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients registered at the Gill Medical Centre, who have a cervix, are eligible for cervical screening and have been non responders to the automated national invitation. These patients are opportunistically recruited when they are consulted by the principal investigator.
Key inclusion criteria (2 listed)
- Registered patient with a cervix
- Non responder to cervical screening invitation
Key exclusion criteria (4 listed)
- Incorrectly reminded i. Coding errors ii. Human error
- Temporary patients i. Did not remain registered for minimum of 6 months following intervention
- Screening refusal
- Inappropriate to include i. Terminal illness ii. Prolonged hospitalisation iii. Death due to non-cervical cancer attributable cause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Screening ReminderVerbal reminder and if seen face-to-face, a written appointment booking slip. | Behavioural | Intervention |
Primary outcome
Uptake of Cervical Screening
Time frame: Up to 1 year post intervention
The number of patients who undergo cervical screening
1 secondary outcome
Time to book screening
Time frame: Up to 1 year post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Background: PubMed 21563135Everett T, Bryant A, Griffin MF, Martin-Hirsch PP, Forbes CA, Jepson RG. Interventions targeted at women to encourage the uptake of cervical screening. Cochrane Database Syst Rev. 2011 May 11;2011(5):CD002834. doi: 10.1002/14651858.CD002834.pub2.
- Individual participant dataSharing planned: Yes. The IPD will be shared with researchers who confirm the purpose of their request and are affiliated with a research organisation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faizan A Awan, MBChB MRCGP principal investigator
The Gill Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV-Related Cervical Carcinoma and Physician-Patient Relations, run by Dr. Faizan Awan at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of Cervical Screening (time frame: Up to 1 year post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04970394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.