Cervical CancerNCT06431724
A Review of Cervical Cancer Screening Practices in Women Age >65
An observational study of Cervical Cancer, run by Sarasota Memorial Health Care System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Patient Survey and Provider Survey
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to 28 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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))
- 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.
Who cannot join
- 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:
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
About this study
Official title: 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.
Read the 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
- Cervical Cancer
- Being tested
- Patient Survey, Provider Survey
- Keywords
- cervical cancer screening, cervical cancer, geriatric cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient SurveyOther
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 SurveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient Survey | |
| Primary care providers and gynecologic providers | 100 Licensed Primary Care and Gynecologic Providers which includes APRNs, PAs, and Physicians. Receives: Other: Provider Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start31 Jul 2023
- Primary completion28 Jul 2024 (estimated)
- Study completion28 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarasota Memorial Health Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamela Fonseca, Sarasota Memorial Health Care System
- Investigators
- Tamela Fonseca, PhD, RN, CCRC, Principal investigator, Sarasota Memorial Health Care System Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431724
- Sponsor's protocol ID
- 23-ONC-34
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31812369Bujang 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.
PubMed 30914882Dilley 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.
PubMed 33926748Feldman 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.
PubMed 30256336Harris 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.
PubMed 18929686Harris 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.
PubMed 31078660Mills 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.
PubMed 34090706Qin 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.
PubMed 34507826Saslow 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.
PubMed 22431528Surveillance, 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.
PubMed 28616007Yost 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.
PubMed 30023421
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of Adherence to National Cervical Cancer Screening Recommendations in Women Age >65
- ClinicalTrials.gov ID
- NCT06431724
- Acronym / sponsor ID
- 23-ONC-34
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer screening, cervical cancer, geriatric cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sarasota Memorial Health Care SystemUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 28 Jul 2024 (estimated)
- Study completion
- 28 Jul 2024 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women >65 years who are considered at risk of developing cervical cancer | – | Other: Patient Survey200 women >65 years who are considered at risk of developing cervical cancer. |
| Primary care providers and gynecologic providers | – | Other: Provider Survey100 Licensed Primary Care and Gynecologic Providers which includes APRNs, PAs, and Physicians. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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))
- 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.
Key exclusion criteria (7 listed)
- Woman has a history of prior hysterectomy.
- Woman is age 65 years and under
- Woman does not receive gynecologic services within SMHCS/FPG network.
- Provider does not practice in the United States.
- Provider does not provide gynecological screenings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient SurveyA simple data intake collection from the patients regarding their medical history that will allow the researchers to assess if recommended guidelines were followed. | Other | Women >65 years who are considered at risk of developing cervical cancer |
| Provider SurveyA 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. | Other | Primary care providers and gynecologic providers |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 31812369Arbyn 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.
- Background: PubMed 30914882Bujang 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.
- Background: PubMed 33926748Dilley 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.
- Background: PubMed 30256336Feldman 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.
- Background: PubMed 18929686Harris 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.
- Background: PubMed 31078660Harris 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.
- Background: PubMed 34090706Mills 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.
- Background: PubMed 34507826Qin 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.
- Background: PubMed 22431528Saslow 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.
- BackgroundSurveillance, Epidemiology, and End Results (SEER) Cancer Stat Facts: Cervix uteri Cancer, n.d.
- Background: PubMed 28616007Tsang 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.
- Background: PubMed 30023421Yost 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.
- ACOG Updated Cervical Cancer Screening GuidelinesLink provided by the sponsor.
- Centers for Disease Control and Prevention (CDC), 2019Link provided by the sponsor.
- Centers for Disease Control and Prevention (CDC), 2022Link provided by the sponsor.
- U.S. Census Bureau (2022). QuickFactsLink provided by the sponsor.
- United States Preventative Task Force (USPTF). Cervical Cancer Screening. August 21, 2018.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamela Fonseca, PhD, RN, CCRC principal investigator
Sarasota Memorial Health Care System Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Sarasota Memorial Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06431724, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.