Intervention With General Practitioners to Improve Women's Participation in Cervical Cancer Screening

Not Applicable

Not yet recruiting

• Conditions: Cervical Cancer
• Interventions: Other: participation of the general practitioner

• Registration Number: NCT06527456
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

In France, cervical cancer is the 12th most common female cancer with nearly 3,000 new cases per year.

Since 2018, a national Organized Cervical Cancer Screening program (DOCCU) has been set up and concerns all asymptomatic women aged 25 to 65.

This program, managed by the Regional Cancer Screening Coordination Centers (CRCDC), invites women who have not taken a sample within the recommended time frame to consult for screening. However, only 59% of patients participated.

The intervention of the general practitioner, an essential player in prevention, could allow for better awareness.

The objective of the INDIGO study is to evaluate the effectiveness of the intervention of a general practitioner on the participation rate in the DOCCU of patients who are not up to date with their screening.

Detailed Description

This is a cluster-randomized trial. Randomization will be performed at the GP practice level to limit the potential contamination bias between doctors within the same practice. GP practices will be randomized either to the 'usual practice' arm or the 'intervention' arm."

If they are in the "intervention" group, they or one of the professionals in their team will contact the patient (phone call, SMS, email, etc.), to encourage her to make an appointment to carry out the screening. Contact arrangements are left to the discretion of each general practitioner..

If they are in the "Usual practice" group, they will use their usual practices to encourage screening.

Study Timeline

• Study First Submitted: 2023-10-20
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03
• Study Start: 2025-09
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 11200

Inclusion Criteria

• Woman aged 25 to 65 living in Ile-De-France
• Eligible for DOCCU (not hysterectomized, not followed for a pre-cancerous or cancerous lesion of the cervix)
• Having declared the investigating general practitioner as a treating physician (MT) and whose MT practices in the territory of a CPTS in the UPEC area
• Affiliate to a social security scheme or beneficiary of such a scheme

Exclusion Criteria

• Patient already included in a study on DOCCU
• Patient excluded from organized screening (cervical cancer, hysterectomy).
• Patient's opposition to participating in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	participation of the general practitioner	the general practitioner or one of the professionals on their team will contact the patient (phone call, SMS, email, etc.), to encourage them to make an appointment to carry out the screening

Primary Outcome Measures

Name	Time	Method
screening participation rate	12 month	percentage of patients who had a screening Cervical Sample (cytology or HPV test within a timeframe satisfying the HAS recommendations according to age) among patients eligible for screening aged 25 to 65 years