A Review of Cervical Cancer Screening Practices in Women Age >65

May 22, 2024 updated by: Tamela Fonseca, Sarasota Memorial Health Care System

A Prospective Analysis of Adherence to National Cervical Cancer Screening Recommendations in Women Age >65

The goal of this research study is to examine adherence to national guidelines for cervical cancer screening in women age >65. Patient surveys will provide information about women age >65 current cervical screening practices and allow researchers to compare that information to national recommended guidelines regarding cervical screenings. Provider surveys will provide information from surveyed providers about screening knowledge and current provider practices for women patients > 65 for cervical cancer. The results may be used to make future recommendations for improving gynecological care and to help develop effective strategies for ensuring guideline adherence.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This prospective study will be conducted to determine adherence to the national guidelines for cervical cancer screening in women >65. A nonpaired patient and provider survey will be utilized to assess both provider and patient adherence to the national cervical cancer screening guidelines. Providers who meet study eligibility will be asked to complete a survey containing questions regarding their current practice for cervical cancer screening, the guidelines they follow, and their decision-making process when deciding who to screen. Patients who meet study eligibility will be asked to complete a survey detailing the frequency and types of cervical cancer screenings they have had and any relevant outcomes. The aims of the study are to assess cervical cancer screening practices among at risk women age >65 years and describe adherence to nationally recommended cervical cancer screening guidelines for this same patient group and among primary care providers (PCPs) and gynecologists. To assess adherence, the Sarasota Memorial Research Institute (SMRI) will conduct a research study which includes patients age >65 from the Sarasota Memorial Health Care System (SMHCS) and their First Physician's Group (FPG) affiliates and providers. Patients who agree to participle will be surveyed to determine their behaviors surrounding cervical cancer screenings. Primary care physicians and gynecologists who are either members of the American Academy of Family Physicians (AAFP), ACOG, or practice within SMHCS or FPG providers who agree to participate will also receive a separate one-time survey to assess adherence to the ACOG, ACS, and USPSTF guidelines for conducting cervical cancer screenings. The target survey sample size for this study will be 200 patients, women >65 years who are considered at risk of developing cervical cancer (women with a history of a hysterectomy will be excluded) and receive gynecological services at SMHCS. In addition, 100 primary care physicians (PCPs) and gynecologists will be targeted.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Health Care System

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The sample size for this study will consist of 200 patients and 100 providers who are comprised of PCPs and gynecologists affiliated with the American Academy of Family Physicians (AAFP) or the American College of Obstetricians and Gynecologists (ACOG) or who are practitioners within SMHCS/FPG locations.

Description

For participants:

Inclusion Criteria:

  • Women age >65 who have not had a hysterectomy.
  • Women who received gynecological services within the SMHCS/FPG network FPG physician offices -Primary Care or Gynecologic Care))

Exclusion Criteria:

  • Woman has a history of prior hysterectomy.
  • Woman is age 65 years and under
  • Woman does not receive gynecologic services within SMHCS/FPG network.

For providers:

Inclusion Criteria:

  • Licensed Primary Care and Gynecologic Providers which includes APRNs, PAs, and Physicians.
  • Provider practices in the U.S.
  • Provider performs gynecological screenings as part of their current practice.

Exclusion Criteria:

  • Provider does not practice in the United States.
  • Provider does not provide gynecological screenings.
  • Provider does not have an active license as a Primary Care Provider or Gynecologic Provider (APRNs, PAs, or Physicians).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women >65 years who are considered at risk of developing cervical cancer
200 women >65 years who are considered at risk of developing cervical cancer.
Other: Patient Survey
A simple data intake collection from the patients regarding their medical history that will allow the researchers to assess if recommended guidelines were followed.
Primary care providers and gynecologic providers
100 Licensed Primary Care and Gynecologic Providers which includes APRNs, PAs, and Physicians.
Other: Provider Survey
A survey will be used to evaluate providers' practices, knowledge and adherence to guidelines, and decision making related to current practice for cervical screening in women >65.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exact binomial 95% confidence intervals will be used.
Time Frame: Both patient and provider surveys are one-time only events. Their participation is limited to only the single time they take the survey which is estimated to take approximately 15 minutes.
To report adherence to national guidelines within each group, exact binomial 95% confidence intervals will be used. A multi-variant analysis will be conducted to determine the frequency, types, and outcomes of cervical cancer screening/s performed and patient and provider characteristics associated with guideline adherence.
Both patient and provider surveys are one-time only events. Their participation is limited to only the single time they take the survey which is estimated to take approximately 15 minutes.

Collaborators and Investigators

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

Sponsor

Sarasota Memorial Health Care System

Investigators

  • Principal Investigator: Tamela Fonseca, PhD, RN, CCRC, Sarasota Memorial Health Care System Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

July 31, 2023

Primary Completion (Estimated)

July 28, 2024

Study Completion (Estimated)

July 28, 2024

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-ONC-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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