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The opportunity of a home, self-collected sample, opens the chance to remove some of the barriers that may discourage women from participating to screening programmes or performing HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as compared with tests performed at a clinic. It allows for privacy, reduces discomfort and women know nobody would have to handle their body.
Study hypothesis: The use of a self-sampler may increase the recovery of non-responders women at cervical cancer screening.
In a previous trial (ISRCTN96071600) the investigators tested on 2400 women, compliance with self sampler device (PantaRhei Devices, Zeist, the Netherlands).
With this study the investigators analyze the response to two channels of transmission of the device (a model of device easier, and less expensive than the previous), such as screening for colon cancer.
The shipment of the device at home and taking on a local pharmacy. Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control 1 | standard recall letter to perform HPV test at the clinic | ||
| Intervention 1 | direct mailing of the self sampling device at home | ||
| intervention 2 | invitation to retire the self sampling device in local pharmacy |
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| Measure | Description | Time Frame |
|---|---|---|
| performing a HPV test within 3 months since the recall letter | up to december 2012 (up to 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| How many of the women performing a test after intervention were never-screened or under-screened (last test more than 3 years before) | up to december 2012 (up to 3 months) |
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Inclusion Criteria:
All women (aged 35-64 years) non-responding to the screening invitation in the previous year and eligible for recall
Exclusion Criteria:
does not meet inclusion criteria
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Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).
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| Name | Affiliation | Role |
|---|---|---|
| Emma Altobelli, Prof. | AUSL4 Teramo - Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AUSL4 Teramo | Teramo | TE | 64100 | Italy |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25633037 | Derived | Giorgi Rossi P, Fortunato C, Barbarino P, Boveri S, Caroli S, Del Mistro A, Ferro A, Giammaria C, Manfredi M, Moretto T, Pasquini A, Sideri M, Tufi MC, Cogo C, Altobelli E; HPV Self-sampling Italian Working Group. Self-sampling to increase participation in cervical cancer screening: an RCT comparing home mailing, distribution in pharmacies, and recall letter. Br J Cancer. 2015 Feb 17;112(4):667-75. doi: 10.1038/bjc.2015.11. Epub 2015 Jan 29. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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vaginal washings
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |