## Protocol Section
### Identification Module
**NCT ID:** NCT06431724

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 23-ONC-34
#### Organization
**Class:** OTHER
**Full Name:** Sarasota Memorial Health Care System
### Status Module
#### Completion Date
**Date:** 2024-07-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-07-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-07-31

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sarasota Memorial Health Care System

#### Responsible Party

**Investigator Affiliation:** Sarasota Memorial Health Care System

**Investigator Full Name:** Tamela Fonseca

**Investigator Title:** Director of Research

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cervical Cancer

**Keywords:**

- cervical cancer screening

- cervical cancer

- geriatric cancer

### Design Module

#### Design Info

**Observational Model:** ECOLOGIC_OR_COMMUNITY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 200 women \>65 years who are considered at risk of developing cervical cancer.

**Intervention Names:**

- Other: Patient Survey

**Label:** Women >65 years who are considered at risk of developing cervical cancer

#### Arm Group 2

**Description:** 100 Licensed Primary Care and Gynecologic Providers which includes APRNs, PAs, and Physicians.

**Intervention Names:**

- Other: Provider Survey

**Label:** Primary care providers and gynecologic providers

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Women >65 years who are considered at risk of developing cervical cancer

**Description:** A simple data intake collection from the patients regarding their medical history that will allow the researchers to assess if recommended guidelines were followed.

**Name:** Patient Survey

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Primary care providers and gynecologic providers

**Description:** 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.

**Name:** Provider Survey

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** 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.

### Eligibility Module

**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).

**Healthy Volunteers:** True

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sarasota

**Country:** United States

**Facility:** Sarasota Memorial Health Care System

**State:** Florida

**Zip:** 34239

#### Overall Officials

**Official 1:**

**Affiliation:** Sarasota Memorial Health Care System Research Institute

**Name:** Tamela Fonseca, PhD, RN, CCRC

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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. Erratum In: Lancet Glob Health. 2022 Jan;10(1):e41.

**PMID:** 31812369

**Citation:** 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.

**PMID:** 30914882

**Citation:** 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.

**PMID:** 33926748

**Citation:** 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.

**PMID:** 30256336

**Citation:** 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.

**PMID:** 18929686

**Citation:** 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.

**PMID:** 31078660

**Citation:** 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.

**PMID:** 34090706

**Citation:** 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.

**PMID:** 34507826

**Citation:** 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.

**PMID:** 22431528

**Citation:** Surveillance, Epidemiology, and End Results (SEER) Cancer Stat Facts: Cervix uteri Cancer, n.d.

**Citation:** 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.

**PMID:** 28616007

**Citation:** 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.

**PMID:** 30023421

#### See Also Links

**Label:** ACOG Updated Cervical Cancer Screening Guidelines

**URL:** https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/04/updated-cervical-cancer-screening-guidelines

**Label:** Centers for Disease Control and Prevention (CDC), 2019

**URL:** http://www.cdc.gov/cancer/uscs/about/data-briefs/no11-gynecologic-cancer-incidence-UnitedStates-2012-2016.htm

**Label:** U.S. Census Bureau (2022). QuickFacts

**URL:** http://www.census.gov/quickfacts/sarasotacountyflorida.

**Label:** United States Preventative Task Force (USPTF). Cervical Cancer Screening. August 21, 2018.

**URL:** http://www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000002577

- Term: Uterine Cervical Diseases

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5830

- Name: Uterine Cervical Neoplasms

- Relevance: HIGH

- As Found: Cervical Cancer

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002583

- Term: Uterine Cervical Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
