Breast Cancer-Related Approach for Increasing Cervical Cancer Screening (BRAICS)

Jessica Di Vincenzo Sormani

Status

Enrolling

Conditions

Cervical Cancer Screening

Treatments

Behavioral: Home-based HPV self-sampling

Behavioral: Sensitization to Cervical Cancer (CC) screening

Study type

Interventional

Funder types

Other

Identifiers

NCT07171658

32HW-0_228666

Details and patient eligibility

About

The primary objective of this clinical trial is to assess cervical cancer screening participation among under-screened women invited through organized breast cancer screening programs in Switzerland.

This randomized trial will compare three arms:

Intervention group 1: Sensitization to Cervical Cancer (CC) screening Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.
Intervention group 2: Home-based Human papillomavirus infection (HPV) self-sampling Women will receive a free-of-charge vaginal self-sampling kit for HPV infection
Observational control group Women selected in the control arm will only be recruited one year following the screening of those in the intervention arm (T0+1), as to not influence Cervical Cancer Screening (CCS) behavior during this period by being reminded of screening recommendations.

Full description

Secondary objectives are:

To identify and compare the association of socio-demographic characteristics with screening participation in all study arms (cf. 3.2 study design).
To compare the use of primary screening methods (HPV test vs. Papanicolaou test) between study arms.
To compare prevalence of positive primary screening and triage results between study arms.
To compare follow-up rates for participants screened positive in both intervention arms.
To evaluate acceptability of both screening strategies (sensitization vs. home-based).
To assess the relationship between CCS behavior and Breast Cancer Screening (BCS) behavior.

Enrollment

4,500 estimated patients

Sex

Female

Ages

50 to 74 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women receiving Breast Cancer Screening (BCS) invitation letters in the selected five cantons (Geneva, Bern (francophone), Jura, Neuchâtel, and Vaud)
Aged 50 to 74 years old
Not been screened for cervical cancer in the past three years
Speaking one of the 6 languages of the study (French, German, Italian, and in English, Spanish, and Portuguese)

Exclusion criteria

Prior cervical cancer diagnosis,
Hysterectomy
Non consent to participate to the study
Incapable of judgment or under tutelage
Pregnancy

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4,500 participants in 2 patient groups

Intervention Group 1: Sensitization to Cervical Cancer (CC) screening

Experimental group

Description:

Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.

Treatment:

Behavioral: Sensitization to Cervical Cancer (CC) screening

Intervention Group 2: Home-based HPV self-sampling

Experimental group

Description:

Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.

Treatment:

Behavioral: Home-based HPV self-sampling