Cervical CancerAdh-NYC-EPNCT02406391
Adherence to Preventive Care for Cervical Cancer
An observational study of Cervical Cancer and Cervical Precancer, run by Brookdale University Hospital Medical Center at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Precancer, Adherence
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients who present to the gynecology clinic for a Pap smear exam or a colposcopy exam following an abnormal Pap smear.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
Leonid Fradkin, PhD, 718-240-8225, lfradkin@bhmcny.org
Thelma Carrillo, MPH, 718-240-5978, tcarrill@bhmcny.org
University of Texas at El Paso
El Paso, Texas, 79902
Texas Tech University Health Science Center
El Paso, Texas, 79905
Christina M Gutierrez, MS, 915-215-5103, cm.gutierrez@ttuhsc.edu
Zuber D Mulla, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Cancer, Cervical Precancer, Adherence
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-2 hour interview during clinic visit and review of patients' medical records during surveillance period (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brookdale University Hospital Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Follen, Brookdale University Hospital Medical Center
- Investigators
- Michele Follen, MD, PhD, Principal investigator, Brookdale University Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406391
- Sponsor's protocol ID
- 14-40
- Acronym
- Adh-NYC-EP
- Status last verified
- Apr 2015
- First submitted
- 16 Mar 2015
- Last updated
- 10 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Screening and Follow-up Diagnostic and Treatment Services for Cervical Cancer Prevention
- ClinicalTrials.gov ID
- NCT02406391
- Acronym / sponsor ID
- Adh-NYC-EP / 14-40
- Conditions
- Cervical Cancer, Cervical Precancer, Adherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Brookdale University Hospital Medical CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients who present to the gynecology clinic for a Pap smear exam or a colposcopy exam following an abnormal Pap smear.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Follen, MD, PhD principal investigator
Brookdale University Hospital and Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Cervical Precancer, run by Brookdale University Hospital Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonid Fradkin, PhD (718-240-8225, lfradkin@bhmcny.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.