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:
- 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)
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
-
-
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;
|
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.
|
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
Collaborators
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.
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.