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Recruiting NCT06527456

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

No phase Interventional Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: participation of the general practitioner.
Who it may be relevant to
Registry conditions: Cervical Cancer. Basic parameters: 25 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other participation of the general practitioner
    participation of the general practitioner in encouraging cervical cancer screening

Primary outcome measures

  • screening participation rate [Time frame: 12 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • Médecins généralistes dans le bassin de l'UPEC — Créteil

Identifiers

NCT: NCT06527456 · INDIGO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗