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

This study has been completed.
Sponsor:
Collaborators:
Vastra Gotaland Region
Assar Gabrielsson Cancer Foundation, Sweden
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01029990
First received: December 9, 2009
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Cervical Intraepithelial Neoplasia
Other: Telephone arm
Other: Self-test arm
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Screening
Official Title: Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Frequency of testing (cytology in arm A and C and HPV-test in arm B). F [ Time Frame: 7 months after invitation ] [ Designated as safety issue: No ]
  • Frequency of further assessment of abnormal tests [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of abnormal smears. (Arm A vs arm C) [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Frequency of treated CIN (Arm A vs. arm C) [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Number of invasive cancers detected classified by FIGO stadium. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Cost of interventions [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Cost per CIN2+ found and treated [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Enrollment: 8800
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   29 Years to 63 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029990

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

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01029990     History of Changes
Other Study ID Numbers: OCGbgSw0101
Study First Received: December 9, 2009
Last Updated: August 29, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
participation
mass screening
cervical neoplasia
health economics
cost-benefit

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

ClinicalTrials.gov processed this record on July 24, 2014