Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by the General Practitioner

Study Overview
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Brief Summary
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This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to the French opportunistic cervical cancer screening program, of an organized screening with the proposition by the family physician of a pap-test (usual care) versus a self-collected vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that organizing the screening for these women involving their family physician will major participation, and that the self-sampling option will amplify this increase.

Detailed Description
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In France screening for cervical cancer (CC) is usually based on an opportunistic screening program. French guidance recommends performing a smear every 3 years from the age of 25 to 65 years, after 2 initial normal yearly smears. Pap-tests can be carried out by medical doctors or midwifes. The coverage rate is estimated between 56.6% and 83.0%. In deprived populations, about 55% of women are unscreened as their risk to develop a CC is majored. The gynecologic examination and the consultation of a gynecologist appear to be the main barriers to the pap-test. Almost all these unscreened women visit their family physician at least yearly for themselves or with a relative, but many family physicians do not perform pap-tests. Our hypothesis is that more women are to be screened if they are invited to by their family physician (who carries out the pap-test himself or who refers the woman to a gynecologist or a midwife), and that the screening rate will be majored if the family physician delivers to his female patients, who are not willing to undergo a pap-smear, a vaginal self-sampling device. To demonstrate this, we will conduct an open label 1:1 cluster randomized controlled trial. As the gender of the physician and his ability to carry out pap-tests is associated to the rate of his listed screened female patients, randomization will be stratified on these two variables. The 24 participating physicians (12 in each study arm) will enroll 2000 unscreened female patients. The study population will be all the social security insured unscreened listed women aged from 30 to 65 years of the participating physicians. As the specificity of the HPV-test to screen for CC is insufficient before the age of 30, woman between 25 and 29 years of age will not be part of the study. All these women (unless an exclusion criterion appears in their medical record) will receive from their family physician an invitation letter to make an appointment for an encounter dedicated to CC screening. Women who accept to be enrolled in the study will sign a consent form and will be invited to fill in a questionnaire about their socio-economic profile and their beliefs and attitudes about prevention, cancer screening in general and screening for CC in particular. Participation to the screening process is not necessary for inclusion. Women in the control arm will be solely proposed to undergo a pap-test performed by their family physician or a gynecologist or a midwife. Women in the intervention arm will be alternatively proposed to proceed to an at home performed vaginal self-collection of a sample that is to be send by post to a centralized lab for HPV testing. HPV tests will be conducted by the virology lab of the University Hospital of Lille. All screened negative women in both arms of the study will be considered as successful outcomes and finish the study. HPV screened positive women from the self-collection arm will be proposed a triage pap-test or colposcopy. Further 18 months follow-up will be matching French guidelines.

Official Title
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Participation in Screening for Cervical Cancer: Interest of a Human Papillomavirus (HPV) Self-sampling Device Provided by the General Practitioner; a Cluster Randomized Clinical Trial

Conditions
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Malignant Tumor of Cervix, Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Device: Vaginal self-sampling brush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be a woman Aged from 30 to 65 years (30 and 65 years included) Without reimbursement of a pap-test by the health insurance for more than 3 years, despite a reminder mailed by the health insurance on the previous year (list set up by the health insurance). Able to understand and sign voluntarily the consent to participate Warranted by the health insurance Able to understand and answer the questions of the study questionnaire alone or with the help of a self-chosen third party. Exclusion Criteria: No vaginal intercourse ever Pap-test quoted on another budget (hospital, mother and child protection…) conducted less than 3 years ago Known cervical lesion or known HPV status History of hysterectomy History of conisation History of laser treatment of the cervix History of cervical cancer Other medical reason to delay cervical cancer screening Abroad for more than one year Moving to another region (done or expected) Pregnant or breastfeeding Screening not relevant from the practitioner's perspective (Emergency situation, comorbidity…)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-sampling for HPV test<br>Invitation to participate to the screening process by means of the usual care (pap-test) or the provision of a vaginal self-sampling brush (Evalyn Brush°). Self-collected samples are mailed to a central lab for HPV testing. | Device: Vaginal self-sampling brush<br>* Self-collection by unscreened women aged from 30 to 65 of a vaginal sample with the device. After collection, the whole device is mailed in a normalized for biological samples package to the virology lab of the University Hospital of Lille where a HPV test is conducted using a Cobas 4800 technique.<br>* Other names: European Community (EC) certificate N°: 44232121392;|
| No Intervention: Usual care (Pap test)<br>Intervention: invitation to participate to the screening process by means of the usual care (pap-test). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of women terminating the whole diagnostic process. | Women participating in the study but refusing the screening process are considered as failure | For screening: 12 months; for follow-up of screened positive subjets: 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Theory of planned behavior (TPB) see Ajzen-Fishbein | Data collected by self-completed questionnaire.psychological determinants of screening in 7 groups of variables (Attitudes, norms, Self-efficacy, intention, environmental factors, skills and abilities, behavior) | At baseline | 
| social determinants of screening (age, level of education, level of resources, vocational situation, matrimonial status…) | Data collected by self-completed questionnaire | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mass screening, Family medicine, Human Papillomavirus DNA tests, Papanicolaou test, Early detection of cancer/methods*, Specimen Handling/methods*, Patient compliance, Adult, Female, Humans, Randomized controlled trial