Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00977392
First received: September 12, 2009
Last updated: August 6, 2013
Last verified: September 2009
  Purpose

RATIONALE: Women who do not undergo routine cervical screening may be more likely to collect a self-sample for human papillomavirus testing.

PURPOSE: This randomized clinical trial is studying self-sampling in women who do not undergo routine cervical screening.


Condition Intervention
Health Status Unknown
Precancerous Condition
Behavioral: compliance monitoring
Other: cervical Papanicolaou test
Other: educational intervention
Other: screening questionnaire administration
Other: survey administration
Procedure: colposcopy

Study Type: Observational
Official Title: The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison of the percentages of women responding to the invitation to return a self-sampling kit vs responding to an invitation for a cervical smear [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response to the invitation for further investigation following a positive test result (colposcopy for women with a smear showing mild dyskaryosis or above, smear +/- colposcopy for those with a positive HPV test) [ Designated as safety issue: No ]
  • Response to the request to return a survey regarding demographic information and reasons for previous non-attendance for screening [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: June 2009
Study Completion Date: March 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To ascertain whether women who do not attend for cervical screening are more likely to respond to the opportunity to collect a self-sample for human papillomavirus (HPV) testing, or to respond to a further invitation to undergo a cervical smear.
  • To ascertain whether such women will attend for further investigation if they have a positive screening test (HPV test or cervical smear).

OUTLINE: Patients are randomized to 1 of 2 arms.

  • Control: Patients receive an invitation for a routine cervical smear and a cervical screening survey. Information regarding attendance for smear or colposcopy is collected at the Primary Care Trust.
  • Study (self-sampling kit): Patients receive an explanatory letter, an information sheet about the study, a consent form, information about human papillomavirus (HPV) and HPV testing, a self-sampling test kit, and an invitation to take their own HPV sample and return it to the research group for processing. Patients also receive a cervical screening survey. Patients who attend for further investigation following a positive HPV result go to St. Mary's Hospital Colposcopy Unit, Paddington. During this visit cervical smear tests are performed and women are offered immediate colposcopy so that they would not need to return for colposcopic examination if their smear test is abnormal.

This study is peer reviewed and funded or endorsed by cancer research UK.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Women in Westminster Primary Care Trust (PCT) area eligible for routine cervical screening who have not responded to two invitations to attend for smears
  • No women who have written to the PCT to document their refusal to take part in the National Health Service Cervical Screening Program (NHSCSP)
  • No women who are not due for routine screening as part of the NHSCSP

PATIENT CHARACTERISTICS:

  • Not pregnant
  • Have been sexually active

PRIOR CONCURRENT THERAPY:

  • No prior total abdominal 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: NCT00977392

Locations
United Kingdom
Barts and the London School of Medicine
London, England, United Kingdom, SW15 5PN
Sponsors and Collaborators
Barts and the London School of Medicine and Dentistry
Investigators
Principal Investigator: Anne Szarewski, MD Queen Mary University of London
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00977392     History of Changes
Other Study ID Numbers: CRUK-Westminster-Self-Sampling, CDR0000648274, ISRCTN40182307, EU-20963
Study First Received: September 12, 2009
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
human papilloma virus infection
health status unknown

Additional relevant MeSH terms:
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014