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Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program

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ClinicalTrials.gov Identifier: NCT01029990
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : August 30, 2012
Vastra Gotaland Region
Assar Gabrielsson Cancer Foundation, Sweden
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
Women who don't participate in Swedish cytology screening program are a minority of about 10%, but constitute the majority of those who acquire cervical cancer. Over 50 000 women in the Västra Götalandregion have abstained from participation in the program for at least 2 screening rounds (6 - 10 years, depending om age). We plan to test two promising strategies to increase participation. In a study of two different health policies women who have defaulted are randomised to receiving a telephone call from a midwife, receive an offer of a self-test for HPV or being included in a control group. This is an effectiveness study that should give an answer how participation could be increased and give the basis for a calculation of the costs involved, before decisions can be made about implementing either intervention.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Other: Telephone arm Other: Self-test arm Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Screening
Official Title: Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program
Study Start Date : September 2009
Primary Completion Date : February 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Telephone arm
A midwife tries to contact the woman by telephone and offer her an appointment for a PAP-smear
Other: Telephone arm
Midwifes at 72 antenatal care units in West region of Sweden receive lists with names and telephone numbers on women who have no record of screening during two screening rounds (6 - 10 years depending on age). The midwife will make up to ten attempts to reach each woman and is instructed to use no more than 30 minutes on this. If the midwife get in touch with the woman she will encourage participation in regular screening (run by midwives in Sweden) and help the woman to get an appointment.
Experimental: Self-test arm Other: Self-test arm
Women receive an offer to order a vaginal self test for HPV. The woman can return a coupon in a postage free envelope and she will receive a self testing kit (dry method) within a couple of days. She will return the test in another postage free envelope. A reminder will be sent to women who order a test but do not return it.
No Intervention: Control arm
No intervention other than what is routine in the screening program

Primary Outcome Measures :
  1. Frequency of testing (cytology in arm A and C and HPV-test in arm B). F [ Time Frame: 7 months after invitation ]
  2. Frequency of further assessment of abnormal tests [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Frequency of abnormal smears. (Arm A vs arm C) [ Time Frame: 7 months ]
  2. Frequency of treated CIN (Arm A vs. arm C) [ Time Frame: 7 months ]
  3. Number of invasive cancers detected classified by FIGO stadium. [ Time Frame: 7 months ]
  4. Cost of interventions [ Time Frame: 7 months ]
  5. Cost per CIN2+ found and treated [ Time Frame: 7 months ]

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Ages Eligible for Study:   29 Years to 63 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • No record of PAP smear in the regional screening register for more than two screening rounds (6 - 10 years depending on age).
  • Evidence in the regional population register that women have been living in the west region of Sweden during this time.

Exclusion Criteria:

  • Total hysterectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029990

Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Assar Gabrielsson Cancer Foundation, Sweden
Principal Investigator: Björn Strander, MD, PhD Göteborg University

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01029990     History of Changes
Other Study ID Numbers: OCGbgSw0101
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by Göteborg University:
mass screening
cervical neoplasia
health economics

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type