cervical cancer screening uptake: a randomised controlled trial assessing the effect of sending invitation letters to nonadherent women

Conditions: Cervical Cancer

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).

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.

Eligibility criteria:
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.

Keywords: cervical cancer screening general practitioner organized screening