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

NCT01029990 | Completed Early Phase 1

• 1 other identifier: OCGbgSw0101
• Study Type: interventional
• Target: 8,800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

participation; mass screening; cervical neoplasia; health economics; cost-benefit

Outcome Measures

Primary Outcomes (2)

• Frequency of testing (cytology in arm A and C and HPV-test in arm B). F

  7 months after invitation

• Frequency of further assessment of abnormal tests

  7 months

Secondary Outcomes (5)

• Frequency of abnormal smears. (Arm A vs arm C)

  7 months

• Frequency of treated CIN (Arm A vs. arm C)

  7 months

• Number of invasive cancers detected classified by FIGO stadium.

  7 months

• Cost of interventions

  7 months

• Cost per CIN2+ found and treated

  7 months

Study Arms (3)

Telephone arm

EXPERIMENTAL

A midwife tries to contact the woman by telephone and offer her an appointment for a PAP-smear

Other: Telephone arm

Self-test arm

EXPERIMENTAL

Other: Self-test arm

Control arm

NO INTERVENTION

No intervention other than what is routine in the screening program

Interventions

Telephone arm OTHER

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.

Telephone arm

Self-test arm OTHER

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.

Self-test arm

Eligibility Criteria

• Age: 29 Years - 63 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Total hysterectomy

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator
• Assar Gabrielsson Cancer Foundation, Sweden: collaborator

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Björn Strander, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: September 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: January 1, 2011
• Last Updated: August 30, 2012

Record last verified: 2012-08