NCT04689178: IMPACTGP

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

Status unknown NA Last updated 6 February 2023

What this trial tests

NA trial testing Invitation letter + GP reminder in Cervical Cancer in 195,000 participants. Status unknown.

Timeline

8 January 2021

Primary endpoint
2 July 2021

2 December 2023

Quick facts

Lead sponsor	Nantes University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	195,000
Start date	8 January 2021
Primary completion	2 July 2021
Estimated completion	2 December 2023
Sites	1 location across France

Drugs / interventions tested

• Invitation letter + GP reminder
• Invitation letter

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

Nantes University Hospital

Who can join

Adults 40 to 65, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cervical cancer screening uptake: A randomized controlled trial assessing the effect of sending invitation letters to non-adherent women combined with sending their general practitioners a list of their non-adherent patients (study protocol).
   Teigné D, Banaszuk AS, Grimault C, Abes L, et al · · 2022 · cited 1× · PMID 36438208 · DOI 10.3389/fpubh.2022.1035288