NCT02750124

Brief Summary

The main purpose is to develop and test an IT-infrastructure to provide more individualized ways of inviting and reaching women who have not participated, despite having been invited with annual reminders, in cervix cancer screening program during a ten year period.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

March 14, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

March 13, 2016

Last Update Submit

September 30, 2020

Conditions

Human Papillomavirus DNA TestsCervical Cancer

Keywords

participationself samplingScreening

Outcome Measures

Primary Outcomes (1)

  • Proportion of women responding (either by and HPV test or a Pap test)

    Participation rate in screening

    From recruitment until end of study on December 31st 2016 (average 8 months)

Study Arms (4)

HPV self sampling test sent

ACTIVE COMPARATOR

A Cobas PCR (polymerase chain reaction) Female swab sample Packet will be sent directly to women with a study invitation letter and instructions. Response rate will be measured.

Device: Cobas PCR Female swab sample Packet

HPV self sampling test ordered

ACTIVE COMPARATOR

An invitation to order a Cobas PCR Female swab sample Packet through an online application will be sent. Response rates will be measured.

Device: Cobas PCR Female swab sample Packet

Nurse navigator contact

ACTIVE COMPARATOR

An invitation to call the coordinating midwife with questions and concerns regarding screening will be sent. The coordinating midwife can help the participant order a Cobas PCR Female swab sample Packet or book a standard screening visit, if desired. Response rates will be measured

Device: Cobas PCR Female swab sample PacketOther: Routine practice

Control

PLACEBO COMPARATOR

The standard, annual renewed invitation to cervical screening will be sent (control, routine practice). Response rate will be measured as a baseline.

Other: Routine practice

Interventions

Cobas PCR Female swab sample PacketDEVICE

The cobas® PCR Female Swab Sample Kit is used to collect and transport vaginal swab specimens self-collected.

HPV self sampling test orderedHPV self sampling test sentNurse navigator contact
Routine practiceOTHER

The standard, annual renewed invitation to cervical screening.

ControlNurse navigator contact

Eligibility Criteria

Age33 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-participants in cervical cancer screening during a 10 year period

You may not qualify if:

  • Active refusers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Elfstrom KM, Sundstrom K, Andersson S, Bzhalava Z, Carlsten Thor A, Gzoul Z, Ohman D, Lamin H, Eklund C, Dillner J, Tornberg S. Increasing participation in cervical screening by targeting long-term nonattenders: Randomized health services study. Int J Cancer. 2019 Dec 1;145(11):3033-3039. doi: 10.1002/ijc.32374. Epub 2019 May 10.

    PMID: 31032904RESULT

  • Andersson S, Belkic K, Mints M, Ostensson E. Acceptance of Self-Sampling Among Long-Term Cervical Screening Non-Attenders with HPV-Positive Results: Promising Opportunity for Specific Cancer Education. J Cancer Educ. 2021 Feb;36(1):126-133. doi: 10.1007/s13187-019-01608-0.

    PMID: 31522376DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Joakim Dillner, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2016

First Posted

April 25, 2016

Study Start

March 14, 2016

Primary Completion

December 31, 2016

Study Completion

December 1, 2021

Last Updated

October 5, 2020

Record last verified: 2020-09