Clinical trial NCT01647724: New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening
Official title: Experimentation of New Organizational Models of Cervical Cancer Screening Programs, Upon the Use of HPV Test as First Level: Evaluation of the Methodologies Proposed of the Use of Self-sampling Devices to Recover Non-responders.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer Cin Grade
Keywords: cervical cancer
prevention
screening
Lead sponsor: Azienda Sanitaria Locale 4, Teramo
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: performing a HPV test within 3 months since the recall letter
timeFrame: up to december 2012 (up to 3 months)
Secondary outcomes:
measure: How many of the women performing a test after intervention were never-screened or under-screened (last test more than 3 years before)
timeFrame: up to december 2012 (up to 3 months)
Other outcomes:
Locations:
city: Teramo
country: Italy
facility: AUSL4 Teramo
state: TE
Study officials:
affiliation: AUSL4 Teramo - Italy
name: Emma Altobelli, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.