Adherence to Preventive Care for Cervical Cancer (Adh-NYC-EP)

April 9, 2015 updated by: Michele Follen, Brookdale University Hospital Medical Center

Adherence to Screening and Follow-up Diagnostic and Treatment Services for Cervical Cancer Prevention

In the United States, the highest incidence of cervical cancer occurs in inner city urban centers, rural areas, the deep South, Appalachia and the U.S.-Mexico border. The goal of this study is to study predictors of adherence among patients seeking care at an inner city medical center in New York City and the U.S. Mexico border for cervical cancer prevention, namely, Pap smears and colposcopy exams.

Study Overview

Status

Unknown

Conditions

Detailed Description

Because there are multiple pathways through which a person is influenced to seek and receive care, the investigators will conduct interviews with patients seeking care for cervical cancer prevention at an inner city medical center. The investigators will ask questions related to previous screening, diagnostic, and treatment practices as well as barriers experienced in seeking such care. The investigators will also explore patients' level of resiliency and coping as predictors of adherence to timely care. Furthermore, among immigrants, questions about acculturation and discrimination will be asked. Additional measures of socioeconomic status, such as education, income and occupation will also be collected.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11212
        • Brookdale University Hospital and Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michele Follen, MD, PhD
    • Texas
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Science Center
        • Contact:
        • Principal Investigator:
          • Zuber D Mulla, PhD
      • El Paso, Texas, United States, 79902
        • University of Texas at El Paso

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Eligible patients who present to the gynecology clinic for a Pap smear exam or a colposcopy exam following an abnormal Pap smear.

Description

Inclusion Criteria:

  • women who are at least 21 years old
  • are seeking care for a Pap smear exam
  • are seeking care for a colposcopy exam for the first time
  • are not pregnant by self-report
  • are able to provide informed consent

Exclusion Criteria:

  • women who do not meet the above eligibility criteria
  • women who have no prior history of a hysterectomy
  • women who have previously participated in this study

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

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to screening, colposcopy and follow-up treatment
Time Frame: 1-2 hour interview during clinic visit and review of patients' medical records during surveillance period (up to 2 years)
A survey will be administered to patients who present for a routine Pap smear exam, a follow-up colposcopy exam. Medical records will be reviewed to document adherence to treatments post-colposcopy
1-2 hour interview during clinic visit and review of patients' medical records during surveillance period (up to 2 years)

Collaborators and Investigators

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

Sponsor

Brookdale University Hospital Medical Center

Investigators

  • Principal Investigator: Michele Follen, MD, PhD, Brookdale University Hospital and Medical Center

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

April 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-40

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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