An observational study in Cervical Cancer, sponsored by Sarasota Memorial Health Care System. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Sarasota Memorial Health Care System · Observational
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 300 is above the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Sarasota Memorial Health Care System is the lead sponsor of 9 studies on the registry; 8 are open to participants now.
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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.
For participants:
Inclusion Criteria:
Exclusion Criteria:
For providers:
Inclusion Criteria:
Exclusion Criteria:
200 women \>65 years who are considered at risk of developing cervical cancer.
Other: Patient Survey
100 Licensed Primary Care and Gynecologic Providers which includes APRNs, PAs, and Physicians.
Other: Provider 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.
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.
Exact binomial 95% confidence intervals will be used.
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.
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.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Sarasota Memorial Health Care System