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

Centre Hospitalier Intercommunal Creteil

Status: Not yet enrolling

Conditions: Cervical Cancer

Treatments: Other: participation of the general practitioner

Study type: Interventional

Funder types: Other

Identifiers

NCT06527456

INDIGO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,200 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11,200 participants in 2 patient groups

usual practice

No Intervention group

Description:

the doctor will use their usual practices to encourage screening.

Intervention

Experimental group

Description:

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

Treatment:

Other: participation of the general practitioner