Cervical Cancer Screening
Conditions
Keywords
cervical cancer screening, underscreened women, HPV self-sampling, Integrated approach
Brief summary
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: 1. 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. 2. 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 3. 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.
Detailed 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.
Interventions
BEHAVIORALSensitization 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.
BEHAVIORALHome-based HPV self-sampling
Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.
Sponsors
University Hospital, Geneva
Jessica Di Vincenzo Sormani
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The study is a 1) population-based 2) randomized trial 3) two-arm 4) open 5) national hybrid 6) completed by an observational control arm .
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation to Cervical Cancer Screening (CCS) | 12 months | Participation to Cervical Cancer Screening (CCS) (primary HPV test or cytology) in the past 12 months, self-declared, proportion in % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Choice of primary screening methods (HPV testing vs cytology) | 12 months | Difference between study arms of the proportion of participants screened by HPV test versus cytology in each arm. |
| Prevalence of positive primary screening (HPS test) and triage results (cytology) | 12 months | Difference between study arms of the: * Prevalence of screen-positive women (i.e. HPV-positive or Atypical squamous cells of undetermined significance - ASC-US+) * Proportion (%) of HPV-positive women with ASC-US+ upon triage * Proportion (%) of Cervical Intraepithelial Neoplasia Grade 2 (CIN2+) diagnosed * Proportion (%) of Cervical Cancer (CC) diagnosed * Proportion (%) of participants treated for CIN2+ or CC |
| Follow-up rates for participants screened positive | 12 months | Difference between study arms of the proportion (%) of primary screen-positive women who have undergone triage |
| Correlation of socio-demographic characteristics with screening participation | 12 months | Regression coefficients of screening in the past 12 months for: education level, occupation, relationship status, sexual orientation, mother tongue, country of origin, residential area, children, follow-up by general practitioner or gynecologist, age, number of years living in Switzerland, Body Mass Index (calculated based on weight and height). Measurement tool: self-reported from questionnaire |
| Reasons for non-compliance | 12 months | Proportion (%) of participants among unscreened women indicating predefined reasons for non-compliance |
| Association between Cervical Cancer Screening (CCS) behavior and Breast Cancer Screening (BCS) screening behaviors | 12 months | Difference in the study arms: of the proportion (%) of participants having done all screenings, and participants having selected only one or two screenings, and participants having done none. |
| Acceptability of screening strategies | 12 months | Difference between study arms of the: \- Mean satisfaction score (Likert scale, from 1 Totalement satisfied to 4 Very unsatisfied) |
Countries
Switzerland
Contacts
Primary ContactJessica Di Vincenzo-Sormani, PhD
Backup ContactPatrick Petignat, MD
Outcome results
None listed