A Review of Cervical Cancer Screening Practices in Women Age >65
NCT ID: NCT06431724
Last Updated: 2024-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
300 participants
OBSERVATIONAL
2023-07-31
2024-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Women who received gynecological services within the SMHCS/FPG network FPG physician offices -Primary Care or Gynecologic Care))
* 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
* Woman is age 65 years and under
* Woman does not receive gynecologic services within SMHCS/FPG network.
For providers:
* 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).
ALL
Yes
Sponsors
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Sarasota Memorial Health Care System
OTHER
Responsible Party
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Tamela Fonseca
Director of Research
Principal Investigators
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Tamela Fonseca, PhD, RN, CCRC
Role: PRINCIPAL_INVESTIGATOR
Sarasota Memorial Health Care System Research Institute
Locations
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Sarasota Memorial Health Care System
Sarasota, Florida, United States
Countries
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References
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Arbyn M, Weiderpass E, Bruni L, de Sanjose S, Saraiya M, Ferlay J, Bray F. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. 2020 Feb;8(2):e191-e203. doi: 10.1016/S2214-109X(19)30482-6. Epub 2019 Dec 4.
Bujang MA, Omar ED, Baharum NA. A Review on Sample Size Determination for Cronbach's Alpha Test: A Simple Guide for Researchers. Malays J Med Sci. 2018 Nov;25(6):85-99. doi: 10.21315/mjms2018.25.6.9. Epub 2018 Dec 28.
Dilley S, Huh W, Blechter B, Rositch AF. It's time to re-evaluate cervical Cancer screening after age 65. Gynecol Oncol. 2021 Jul;162(1):200-202. doi: 10.1016/j.ygyno.2021.04.027. Epub 2021 Apr 26.
Feldman S, Cook E, Davis M, Gershman ST, Hanchate A, Haas JS, Perkins RB. Cervical Cancer Incidence Among Elderly Women in Massachusetts Compared With Younger Women. J Low Genit Tract Dis. 2018 Oct;22(4):314-317. doi: 10.1097/LGT.0000000000000435.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
Mills JM, Morgan JR, Dhaliwal A, Perkins RB. Eligibility for cervical cancer screening exit: Comparison of a national and safety net cohort. Gynecol Oncol. 2021 Aug;162(2):308-314. doi: 10.1016/j.ygyno.2021.05.035. Epub 2021 Jun 3.
Qin J, Shahangian S, Saraiya M, Holt H, Gagnon M, Sawaya GF. Trends in the use of cervical cancer screening tests in a large medical claims database, United States, 2013-2019. Gynecol Oncol. 2021 Nov;163(2):378-384. doi: 10.1016/j.ygyno.2021.08.023. Epub 2021 Sep 8.
Saslow D, Solomon D, Lawson HW, Killackey M, Kulasingam SL, Cain J, Garcia FA, Moriarty AT, Waxman AG, Wilbur DC, Wentzensen N, Downs LS Jr, Spitzer M, Moscicki AB, Franco EL, Stoler MH, Schiffman M, Castle PE, Myers ER; American Cancer Society; American Society for Colposcopy and Cervical Pathology; American Society for Clinical Pathology. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol. 2012 Apr;137(4):516-42. doi: 10.1309/AJCPTGD94EVRSJCG.
Surveillance, Epidemiology, and End Results (SEER) Cancer Stat Facts: Cervix uteri Cancer, n.d.
Tsang S, Royse CF, Terkawi AS. Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi J Anaesth. 2017 May;11(Suppl 1):S80-S89. doi: 10.4103/sja.SJA_203_17.
Yost S, Hoekstra A. Cervical cancer in women over 65: An analysis of screening. Gynecol Oncol Rep. 2018 May 22;25:48-51. doi: 10.1016/j.gore.2018.05.010. eCollection 2018 Aug.
Related Links
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ACOG Updated Cervical Cancer Screening Guidelines
U.S. Census Bureau (2022). QuickFacts
United States Preventative Task Force (USPTF). Cervical Cancer Screening. August 21, 2018.
Other Identifiers
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23-ONC-34
Identifier Type: -
Identifier Source: org_study_id
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