NCT04970394

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
724

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

July 11, 2021

Last Update Submit

August 5, 2021

Conditions

Keywords

Cervical ScreeningPrimary health carePhysician intervention

Outcome Measures

Primary Outcomes (1)

  • Uptake of Cervical Screening

    The number of patients who undergo cervical screening

    Up to 1 year post intervention

Secondary Outcomes (1)

  • Time to book screening

    Up to 1 year post intervention

Study Arms (2)

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".

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.

Interventions

Verbal reminder and if seen face-to-face, a written appointment booking slip.

Intervention

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAny individual with a cervix
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Registered patient with a cervix
  • Non responder to cervical screening invitation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Gill Medical Centre

Salford, Greater Manchester, M28 3DR, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 21563135BACKGROUND

Study Officials

  • Faizan A Awan, MBChB MRCGP

    The Gill Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
General Practitioner

Study Record Dates

First Submitted

July 11, 2021

First Posted

July 21, 2021

Study Start

March 1, 2017

Primary Completion

February 29, 2020

Study Completion

March 3, 2021

Last Updated

August 12, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

The IPD will be shared with researchers who confirm the purpose of their request and are affiliated with a research organisation.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Immediately available for up to 10 years post-publication.
Access Criteria
Contact principal investigator via e-mail.

Locations