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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06527456
Acronym
INDIGO
Enrollment
11200
Registered
2024-07-30
Start date
2026-01-21
Completion date
2027-08-01
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

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.

Interventions

OTHERparticipation of the general practitioner

participation of the general practitioner in encouraging cervical cancer screening

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
screening participation rate12 monthpercentage 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

Countries

France

Contacts

CONTACTEmilie FERRAT
emilie.ferrat@u-pec.fr0633085225
CONTACTCamille JUNG
camille.jung@chicreteil.fr01.57.02.22.68

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026