Promoting Cervical Cancer Screening for Emergency Department Patients

August 19, 2019 updated by: David Adler, University of Rochester

Piloting Interventions to Improve Adherence to Cervical Cancer Screening Recommendations Among Emergency Department Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

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
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester, Department of Emergency Medicine

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: screening and referral
Behavioral: Provider Referral
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.
Active Comparator: behavioral intervention
Behavioral: Text Messaging
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of participants who scheduled or completed cervical cancer screening
Time Frame: 150 days
150 days

Collaborators and Investigators

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

Sponsor

University of Rochester

Collaborators

National Institutes of Health (NIH)

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 (Actual)

June 25, 2018

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB00070962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Withing one year of publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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