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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02406391
Other study ID # 14-40
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 16, 2015
Last updated April 9, 2015
Start date April 2015
Est. completion date December 2017

Study information

Verified date April 2015
Source Brookdale University Hospital Medical Center
Contact Leonid Fradkin, PhD
Phone 718-240-8225
Email lfradkin@bhmcny.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Locations

Country Name City State
United States Brookdale University Hospital and Medical Center Brooklyn New York
United States Texas Tech University Health Science Center El Paso Texas
United States University of Texas at El Paso El Paso Texas

Sponsors (1)

Lead Sponsor Collaborator
Brookdale University Hospital Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to screening, colposcopy and follow-up treatment 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) No
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