Back to resultsPromoting Cervical Cancer Screening for Emergency Department Patients
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provider Referral
Text Messaging
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- Registered patient in the Emergency Department of the University of Rochester Medical Center
- Women
- Age 21 - 65
Exclusion Criteria:
- Past hysterectomy with cervical removal
- Known infection with HIV (screening recommendations for women with HIV differ from the general population)
- Non-English speaking
- Inability to consent
- Lack of text-capable mobile phone and/or inability to use text function
Sites / Locations
- University of Rochester, Department of Emergency Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
screening and referral
behavioral intervention
Arm Description
Outcomes
Primary Outcome Measures
number of participants who scheduled or completed cervical cancer screening
Secondary Outcome Measures
Full Information
NCT ID
NCT03483610
First Posted
March 23, 2018
Last Updated
August 19, 2019
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT03483610
Brief Title
Promoting Cervical Cancer Screening for Emergency Department Patients
Official Title
Piloting Interventions to Improve Adherence to Cervical Cancer Screening Recommendations Among Emergency Department Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to learn methods to encourage women to get recommended cervical cancer screening. Cervical cancer screening is an important part of cervical cancer prevention. The study team will determine if the patient is currently up-to-date with cervical cancer screening recommendations. If the patient is not up-to-date, then they will be randomly assigned to one of two interventions. One intervention consists only of referral to a women's health care provider to obtain cervical cancer screening. The other intervention consists of receiving a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening.
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
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
screening and referral
Arm Type
Active Comparator
Arm Title
behavioral intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Provider Referral
Intervention Description
Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. At the end of the study they will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging
Intervention Description
Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. They will also receive a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening. They will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.
Primary Outcome Measure Information:
Title
number of participants who scheduled or completed cervical cancer screening
Time Frame
150 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only women get cervical cancer screening
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Registered patient in the Emergency Department of the University of Rochester Medical Center
Women
Age 21 - 65
Exclusion Criteria:
Past hysterectomy with cervical removal
Known infection with HIV (screening recommendations for women with HIV differ from the general population)
Non-English speaking
Inability to consent
Lack of text-capable mobile phone and/or inability to use text function
Facility Information:
Facility Name
University of Rochester, Department of Emergency Medicine
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Withing one year of publication
Learn more about this trial
Promoting Cervical Cancer Screening for Emergency Department Patients
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