Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women
- Conditions
- Cervical Cancer
- Interventions
- Other: Invitation letter + GP reminderOther: Invitation letter
- Registration Number
- NCT04689178
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 195000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Invitation letter + GP reminder (Arm 1) Invitation letter + GP reminder - Invitation letter (Arm 2) Invitation letter -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Description of the results of screening tests carried out in first intention 6 months Proportion of abnormal test results (cytology, HPV) among all screening tests performed
Description of the types of tests performed for follow-up of lesions detected 6 months Proportion of "reflex" tests performed (number of cervical smears after a positive HPV result) among abnormal test results
Description of the types of screening tests carried out in first intention 6 months Proportion of HPV tests performed among all screening tests
Description of the factors associated with lower participation in screening 6 months Participation rate according to age (over 50), income (women with low incomes qualifying for basic health coverage) and comorbidities.
Description of the types of tests performed to follow lesions detected by screening 12 months Proportion of biopsies and conizations performed among abnormal screening test results
Description the results of the tests performed to follow lesions detected by screening 12 months Proportion of high-grade lesions detected (second, a third-grade cervical intraepithelial neoplasia, including in situ carcinomas and cancers) among the abnormal screening tests
Description of the treatments undergone by the women following abnormal screening tests 12 months Percentages of treatments performed (conization, laser, hysterectomy) among the abnormal screening tests
Description of the healthcare trajectory of women undergoing a screening test 6 months Proportion of women who resort to a GP, a midwife or a gynaecologist to undergo their screening test
Trial Locations
- Locations (1)
University Hospital
🇫🇷Nantes, France