Cervical Cancer Screening Among Hispanic Women

November 9, 2018 updated by: Fred Hutchinson Cancer Center

Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women

In this study, 400 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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

451

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participant attends cervical cancer screening
Time Frame: Within 7 months of the intervention
Within 7 months of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Navigator
Time Frame: Elapsed time from diagnosis to clinic visit
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 receive a diagnosis of an abnormal Pap test.
Elapsed time from diagnosis to clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Beti Thompson, PhD, Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

July 17, 2018

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (Estimate)

February 3, 2012

Study Record Updates

Last Update Posted (Actual)

November 13, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHCRC IR 7290
  • U54CA153502 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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