Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program
This study has been completed.
Sponsor:
Göteborg University
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
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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 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 May 19, 2013