Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women

NCT04689178 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195000

Last updated 2023-02-06

No results posted yet for this study

Summary

Context:

In France, cervical cancer (CC) screening was opportunistic until recently. The target population includes women aged 25 to 65 years. About 66% of women aged 25-40 years have performed a screening test over the last three years but this figure decreases to 55% in women over 40. The third "Cancer Plan" proposed by the French National Institute for Cancer recommends to achieve an 80% participation in eligible women.

Improving women compliance to CC screening is a major challenge to decrease cancer incidence and mortality.

To improve patient adherence, a CC screening organization will be launched in 2020 at a national scale in France. Women who did not perform a PAP test over the last 3 years will receive an invitation letter from the local public health association in charge of cancer screening organization. The invitation letter will remind women that they should consult a healthcare professional (a general practitioner (GP), a gynecologist or a midwife) to perform a screening test.

Providing GPs with a list of their non-adherent patients could also improve women compliance to CC screening recommendations.

The study objective is to assess whether sending both an invitation letter to non-adherent women and a list of their non-adherent patients to GPs ("invitation letter + GP reminder" group) could increase the proportion of women who perform a screening test, compared to only sending an invitation letter to non-adherent women ("invitation letter" group) or not sending any invitation ("usual care" group).

Conditions

Interventions

OTHER

Invitation letter + GP reminder

40-65 year-old women who did not perform a PAP test over the last 3 years will receive an invitation to consult a health professional to perform a screening test, AND GPs will receive the list of their 40-65 year-old patients who did not perform a PAP test over the last 3 years

OTHER

Invitation letter

40-65 year-old women who did not perform a PAP test over the last 3 years will receive an invitation to consult a health professional to perform a screening test. GPs will NOT receive any list of their non-adherent patients.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Cedric RAT, Professor · Nantes University Hospital

  • Anne-Sophie BANASZUK, Doctor · Centre de coordination des dépistages des cancers (CRCDC)

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2021-07-02
Completion
2023-12-02

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04689178 on ClinicalTrials.gov