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NMDSS2: New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening

Sponsor
Azienda Sanitaria Locale 4, Teramo (Other)
Overall Status
Unknown status
CT.gov ID
NCT01647724
Collaborator
(none)
15,000
Enrollment
1
Location
5.9
Duration (Months)
2522.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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 Start Date :
    Sep 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2012
    Anticipated Study Completion Date :
    Mar 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. performing a HPV test within 3 months since the recall letter [up to december 2012 (up to 3 months)]

    Secondary Outcome Measures

    1. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 64 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AUSL4 Teramo Teramo TE Italy 64100

    Sponsors and Collaborators

    • Azienda Sanitaria Locale 4, Teramo

    Investigators

    • Study Director: Emma Altobelli, Prof., AUSL4 Teramo - Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emma Altobelli, Responsable U.O. Epidemiology and Social Marketing, Azienda Sanitaria Locale 4, Teramo
    ClinicalTrials.gov Identifier:
    NCT01647724
    Other Study ID Numbers:
    • NMD2TE
    First Posted:
    Jul 24, 2012
    Last Update Posted:
    Jul 24, 2012
    Last Verified:
    May 1, 2012
    Keywords provided by Emma Altobelli, Responsable U.O. Epidemiology and Social Marketing, Azienda Sanitaria Locale 4, Teramo
    cervical cancer
    prevention
    screening
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms

    Study Results

    No Results Posted as of Jul 24, 2012