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Context:
In France, cervical cancer (CC) screening was opportunistic until recently. The target population includes women aged 25 to 65 years. About 66% of women aged 25-40 years have performed a screening test over the last three years but this figure decreases to 55% in women over 40. The third "Cancer Plan" proposed by the French National Institute for Cancer recommends to achieve an 80% participation in eligible women.
Improving women compliance to CC screening is a major challenge to decrease cancer incidence and mortality.
To improve patient adherence, a CC screening organization will be launched in 2020 at a national scale in France. Women who did not perform a PAP test over the last 3 years will receive an invitation letter from the local public health association in charge of cancer screening organization. The invitation letter will remind women that they should consult a healthcare professional (a general practitioner (GP), a gynecologist or a midwife) to perform a screening test.
Providing GPs with a list of their non-adherent patients could also improve women compliance to CC screening recommendations.
The study objective is to assess whether sending both an invitation letter to non-adherent women and a list of their non-adherent patients to GPs ("invitation letter + GP reminder" group) could increase the proportion of women who perform a screening test, compared to only sending an invitation letter to non-adherent women ("invitation letter" group) or not sending any invitation ("usual care" group).
Design, Setting and Participants:
The investigators will conduct a 3-arm, cluster-randomized, controlled trial in the Loire-Atlantique region, in France.
The study will include a total of 1,500 GPs and about 100,000 women. The randomization will be based on GP practices to avoid a contamination bias resulting from shared tracking mechanisms and communication between GPs within a given practice. Thus, several GPs working in the same practice will be assigned to the same study arm. Women on the patient list of a given GP will be assigned to the arm of this GP.
Intervention:
After a cluster randomization according to the practice, the GPs and their female patients will be included in one of the following 3 arms:
Expected Results
The investigators expect an increase in the proportion of women who perform a screening test in the intervention arm (arm 1), compared to arms 2 and 3. Previous studies have suggested that the proportion of women adherent to CC screening could be increased by 25% in arm 1 compared to arm 3, whereas the participation could be increased by 15% in arm 2 compared to arm 3.
Considering that the proportion of adherent women in arm 3 should be of about 55%, the absolute increase in participation could reach 11% in arm 1, and 6.6% in arm 2.
A higher adherence to CC screening could improve the detection of pathological lesions by 5% for pathological pap smears and by 10% for positive HPV tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invitation letter + GP reminder (Arm 1) | Experimental |
| |
| Invitation letter (Arm 2) | Active Comparator |
| |
| Usual care (Arm 3) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invitation letter + GP reminder | Other | 40-65 year-old women who did not perform a PAP test over the last 3 years will receive an invitation to consult a health professional to perform a screening test, AND GPs will receive the list of their 40-65 year-old patients who did not perform a PAP test over the last 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women aged 40-65 who performed a screening test (HPV test or PAP smear) over the last 3 years, 6 months after the intervention | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the types of screening tests carried out in first intention | Proportion of cytological tests performed among all screening tests | 6 months |
| Description of the types of screening tests carried out in first intention |
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Inclusion Criteria for GPs:
- All GPs practicing in the Loire-Atlantique region (Western France) will be included.
Inclusion criteria for patients :
Exclusion Criteria for GPs:
- GPs who could refuse to participate by contacting the research team.
Inclusion criteria for patients :
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| Name | Affiliation | Role |
|---|---|---|
| Cedric RAT, Professor | Nantes University Hospital | Principal Investigator |
| Anne-Sophie BANASZUK, Doctor | Centre de coordination des dépistages des cancers (CRCDC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Nantes | 44000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36438208 | Derived | Teigne D, Banaszuk AS, Grimault C, Abes L, Gaultier A, Rat C. Cervical cancer screening uptake: A randomized controlled trial assessing the effect of sending invitation letters to non-adherent women combined with sending their general practitioners a list of their non-adherent patients (study protocol). Front Public Health. 2022 Nov 10;10:1035288. doi: 10.3389/fpubh.2022.1035288. eCollection 2022. |
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|
| Invitation letter | Other | 40-65 year-old women who did not perform a PAP test over the last 3 years will receive an invitation to consult a health professional to perform a screening test. GPs will NOT receive any list of their non-adherent patients. |
|
Proportion of HPV tests performed among all screening tests
| 6 months |
| Description of the results of screening tests carried out in first intention | Proportion of abnormal test results (cytology, HPV) among all screening tests performed | 6 months |
| Description of the types of tests performed for follow-up of lesions detected | Proportion of "reflex" tests performed (number of cervical smears after a positive HPV result) among abnormal test results | 6 months |
| Description of the types of tests performed to follow lesions detected by screening | Proportion of biopsies and conizations performed among abnormal screening test results | 12 months |
| Description the results of the tests performed to follow lesions detected by screening | Proportion of high-grade lesions detected (second, a third-grade cervical intraepithelial neoplasia, including in situ carcinomas and cancers) among the abnormal screening tests | 12 months |
| Description of the treatments undergone by the women following abnormal screening tests | Percentages of treatments performed (conization, laser, hysterectomy) among the abnormal screening tests | 12 months |
| Description of the factors associated with lower participation in screening | Participation rate according to age (over 50), income (women with low incomes qualifying for basic health coverage) and comorbidities. | 6 months |
| Description of the healthcare trajectory of women undergoing a screening test | Proportion of women who resort to a GP, a midwife or a gynaecologist to undergo their screening test | 6 months |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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