Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women

Study Overview
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Brief Summary
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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).

Detailed Description
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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: Invitation letter + GP reminder (Arm 1): 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; Invitation letter (Arm 2): 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. Usual care (arm 3): 40-65 year-old women who did not perform a PAP test over the last 3 years will NOT receive any invitation to consult a health professional to perform a screening test. GPs will NOT receive any list of their non-adherent patients. 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.

Official Title
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Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women Combined With Sending Their General Practitioners a List of Their Nonadherent Patients

Conditions
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Cervical Cancer

Intervention / Treatment
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* Other: Invitation letter + GP reminder
* Other: Invitation letter


Participation Criteria
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Eligibility Criteria
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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 : women aged 40 to 65 years, being on the patient list of the GPs participating in the study, living in the Loire-Atlantique region (Western France), being affiliated to the National Health Insurance. Exclusion Criteria for GPs: - GPs who could refuse to participate by contacting the research team. Inclusion criteria for patients : Refusal to participate to the study Female patients who underwent total hysterectomy and those who received a pathological result of a previous pap smear (asc-us or CIN) are not eligible to participate in the CC screening and therefore excluded from the study. Women not registered with a GP located in Loire-Atlantique will not be included.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Invitation letter + GP reminder (Arm 1)<br> | Other: Invitation letter + GP reminder<br>* 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<br>|
| Active Comparator: Invitation letter (Arm 2)<br> | Other: Invitation letter<br>* 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.<br>|
| No Intervention: Usual care (Arm 3)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer screening, General Practitioner, Organized screening