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Promoting Cervical Cancer Screening for Emergency Department Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483610
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
David Adler, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: Provider Referral Behavioral: Text Messaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Piloting Interventions to Improve Adherence to Cervical Cancer Screening Recommendations Among Emergency Department Patients
Actual Study Start Date : June 25, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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.




Primary Outcome Measures :
  1. number of participants who scheduled or completed cervical cancer screening [ Time Frame: 150 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only women get cervical cancer screening
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483610


Locations
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United States, New York
University of Rochester, Department of Emergency Medicine
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)

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Responsible Party: David Adler, Associate Professor of Emergency Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT03483610    
Other Study ID Numbers: RSRB00070962
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Withing one year of publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Emergencies
Disease Attributes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female