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New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening

NCT ID: NCT01647724

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cervical Cancer Cin Grade

Keywords

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cervical cancer prevention screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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control 1

standard recall letter to perform HPV test at the clinic

No interventions assigned to this group

Intervention 1

direct mailing of the self sampling device at home

No interventions assigned to this group

intervention 2

invitation to retire the self sampling device in local pharmacy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria Locale 4, Teramo

OTHER

Sponsor Role lead

Responsible Party

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Emma Altobelli

Responsable U.O. Epidemiology and Social Marketing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emma Altobelli, Prof.

Role: STUDY_DIRECTOR

AUSL4 Teramo - Italy

Locations

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AUSL4 Teramo

Teramo, TE, Italy

Site Status

Countries

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Italy

Facility Contacts

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Emma Altobelli, Prof.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 25633037 (View on PubMed)

Other Identifiers

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NMD2TE

Identifier Type: -

Identifier Source: org_study_id