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Cervical Cancer Screening Among Hispanic Women

This study is currently recruiting participants.
Verified December 2012 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01525433
First received: January 31, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

In this study, 600 Hispanic women will be recruited and randomized to one of three interventions:

  1. Control (no change);
  2. A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
  3. A higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening.

The investigators will compare which intervention is most effective in encouraging Hispanic women to undergo cervical cancer screening (Pap test)


Condition Intervention
Cervical Cancer Screening
 Behavioral: DVD
Behavioral: Promotora

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Participant attends cervical cancer screening [ Time Frame: Within 7 months of the intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Navigator [ Time Frame: Elapsed time from diagnosis to clinic visit ] [ Designated as safety issue: No ]
    Evaluation of the patient navigator program as a method to improve adherence and reduce time to follow-up among study participants who receive an abnormal Pap test result. Time to follow-up will be compared to a similar population of patients who were not part of the study who also recieve a diangosis of an abnormal Pap test.


Estimated Enrollment: 600
Study Start Date: September 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Active Comparator: Low Intensity Information (DVD)
A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
 Behavioral: DVD
Participants will received a mailed DVD containing culturally appropriate information about the importance of cervical cancer screening
Active Comparator: High Intensity Information (Promotora)
A higher intensity information program consisting of the video plus a 'promotora' or lay-community health educator led-intervention at the participant's home to encourage cervical cancer screening.
 Behavioral: Promotora
Participants will receive a home visit from a lay community health educator ('Promotora') and will be shown a DVD containing culturally appropriate information to educate participants about the importance of cervical cancer screening

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • 21 - 64 years of age
  • Hispanic or Latina
  • Resident of the Yakima Valley, WA, USA
  • No hysterectomy
  • Last PAP test (cervical screening) more than 3 years ago
  • Last seen at the local clinic less than 5 years ago

Exclusion Criteria:

  • Less than 21 or greater than 64 years of age
  • PAP test less 3 years ago
  • Prior hysterectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525433

Contacts
Contact: Elizabeth Carosso 206 667 7569 ecarosso@fhcrc.org
Contact: Catherine Duggan, PhD 206 667 2323 cduggan@fhcrc.org

Locations
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: Beti Thompson, PhD            
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Beti Thompson, PhD Fred Hutchinson Cancer Research Center
  More Information

No publications provided by Fred Hutchinson Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01525433     History of Changes
Other Study ID Numbers: FHCRC IR 7290, U54CA153502
Study First Received: January 31, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013