New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening (NMDSS2)
Recruitment status was: Not yet recruiting
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.
Cervical Cancer Cin Grade
|Study Design:||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.|
- performing a HPV test within 3 months since the recall letter [ Time Frame: up to december 2012 (up to 3 months) ] [ Designated as safety issue: No ]
- How many of the women performing a test after intervention were never-screened or under-screened (last test more than 3 years before) [ Time Frame: up to december 2012 (up to 3 months) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
standard recall letter to perform HPV test at the clinic
direct mailing of the self sampling device at home
invitation to retire the self sampling device in local pharmacy
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647724
|Teramo, TE, Italy, 64100|
|Study Director:||Emma Altobelli, Prof.||AUSL4 Teramo - Italy|