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Breast Cancer-Related Approach for Increasing Cervical Cancer Screening

ConditionCervical Cancer Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-74
SponsorJessica Di Vincenzo Sormani

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Prior cervical cancer diagnosis,

Hysterectomy

Non consent to participate to the study

Incapable of judgment or under tutelage

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sensitization to Cervical Cancer (CC) screening

    Behavioral

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

  • Home-based HPV self-sampling

    Behavioral

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

Treatment groups

4,500 Participants
are divided into 2 treatment groups
Group A: Intervention Group 1: Sensitization to Cervical Cancer (CC) screeningExperimental treatment 1 intervention
Group B: Intervention Group 2: Home-based HPV self-samplingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Participation to Cervical Cancer Screening (CCS)

Participation to Cervical Cancer Screening (CCS) (primary HPV test or cytology) in the past 12 months, self-declared, proportion in %

Time frame
12 months

Secondary outcomes

1

Correlation of socio-demographic characteristics with screening participation

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

Time frame
12 months
2

Choice of primary screening methods (HPV testing vs cytology)

Difference between study arms of the proportion of participants screened by HPV test versus cytology in each arm.

Time frame
12 months
3

Prevalence of positive primary screening (HPS test) and triage results (cytology)

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

Time frame
12 months
4

Follow-up rates for participants screened positive

Difference between study arms of the proportion (%) of primary screen-positive women who have undergone triage

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jessica Di Vincenzo Sormani

Lead sponsor

School of Health Sciences Geneva

Sponsor institution

University Hospital, Geneva

Collaborator

Source ClinicalTrials.gov
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