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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Nantes University Hospital
- Enrollment
- 195,000
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
Arms & Interventions
Invitation letter (Arm 2)
Intervention: Invitation letter (Other)
Usual care (Arm 3)
Invitation letter + GP reminder (Arm 1)
Intervention: Invitation letter + GP reminder (Other)
Outcomes
Primary Outcomes
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
Time Frame: 6 months
Secondary Outcomes
- Description of the types of screening tests carried out in first intention(6 months)
- Description of the results of screening tests carried out in first intention(6 months)
- Description of the types of tests performed for follow-up of lesions detected(6 months)
- Description of the factors associated with lower participation in screening(6 months)
- Description of the types of tests performed to follow lesions detected by screening(12 months)
- Description the results of the tests performed to follow lesions detected by screening(12 months)
- Description of the treatments undergone by the women following abnormal screening tests(12 months)
- Description of the healthcare trajectory of women undergoing a screening test(6 months)