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

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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01647724

Acronym

NMDSS2

Enrollment

15000

Registered

2012-07-24

Start date

2012-09-30

Completion date

2013-03-31

Last updated

2012-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer Cin Grade

Keywords

cervical cancer, prevention, screening

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
performing a HPV test within 3 months since the recall letter	up to december 2012 (up to 3 months)

Secondary

Measure	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)

Countries

Italy

Outcome results