Adherence to Preventive Care for Cervical Cancer

Cervical Cancer Clinical Trial

— Adh-NYC-EP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02406391
• Other study ID #: 14-40
• 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

Related Conditions & MeSH terms

• Adherence
• Cervical Cancer
• Cervical Precancer
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

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

External Links

•   Overarching project website