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Trial Title:
Intervention With General Practitioners to Improve Women's Participation in Cervical Cancer Screening
NCT ID:
NCT06527456
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
participation of the general practitioner
Description:
participation of the general practitioner in encouraging cervical cancer screening
Arm group label:
Intervention
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.
Criteria for 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
Gender:
All
Minimum age:
25 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
December 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Centre Hospitalier Intercommunal Creteil
Agency class:
Other
Source:
Centre Hospitalier Intercommunal Creteil
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06527456
