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Cervical Cancer Screening Among Hispanic Women

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DVD
Promotora
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

21 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control

Low Intensity Information (DVD)

High Intensity Information (Promotora)

Arm Description

A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;

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.

Outcomes

Primary Outcome Measures

Participant attends cervical cancer screening

Secondary Outcome Measures

Patient Navigator
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.

Full Information

First Posted
January 31, 2012
Last Updated
November 9, 2018
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01525433
Brief Title
Cervical Cancer Screening Among Hispanic Women
Official Title
Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
July 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, 400 Hispanic women will be recruited and randomized to one of three interventions: Control (no change); A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening; 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Low Intensity Information (DVD)
Arm Type
Active Comparator
Arm Description
A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
Arm Title
High Intensity Information (Promotora)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DVD
Intervention Description
Participants will received a mailed DVD containing culturally appropriate information about the importance of cervical cancer screening
Intervention Type
Behavioral
Intervention Name(s)
Promotora
Intervention Description
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
Primary Outcome Measure Information:
Title
Participant attends cervical cancer screening
Time Frame
Within 7 months of the intervention
Secondary Outcome Measure Information:
Title
Patient Navigator
Description
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.
Time Frame
Elapsed time from diagnosis to clinic visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beti Thompson, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22559251
Citation
Duggan C, Coronado G, Martinez J, Byrd TL, Carosso E, Lopez C, Benavides M, Thompson B. Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women. BMC Cancer. 2012 May 6;12:170. doi: 10.1186/1471-2407-12-170.
Results Reference
derived

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Cervical Cancer Screening Among Hispanic Women

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