Clinical trial NCT06431724: A Review of Cervical Cancer Screening Practices in Women Age >65
Official title: A Prospective Analysis of Adherence to National Cervical Cancer Screening Recommendations in Women Age >65
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cervical Cancer
Keywords: cervical cancer screening
cervical cancer
geriatric cancer
Lead sponsor: Sarasota Memorial Health Care System
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Exact binomial 95% confidence intervals will be used.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
Study officials:
affiliation: Sarasota Memorial Health Care System Research Institute
name: Tamela Fonseca, PhD, RN, CCRC
role: PRINCIPAL_INVESTIGATOR
References:
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