Cervical CancerNCT02265120
Primary Care Providers' Views and Understanding of Current Recommended Guidelines for Cervical Cancer Screening
A study testing Questionnaire in people with Cervical Cancer, run by University of Southern California at 1 site in United States.
Trial summary
Significant developments have led to a dramatic change in recommendations for cervical cancer screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100% of cervical cancer cases and the development of new technologies for detection of HPV DNA at time of cervical cancer screening, has… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Mar 2015
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary care providers who care for patients within the 194 federally designated regions of Primary Care provider shortage within California
Who cannot join
- Outside of federally designated region of Primary Care provider shortage within California
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Sol Price School of Public Policy
Los Angeles, California, 90007
About this study
Significant developments have led to a dramatic change in recommendations for cervical cancer screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100% of cervical cancer cases and the development of new technologies for detection of HPV DNA at time of cervical cancer screening, has produced changes in preventive healthcare policy for this condition. In an unprecedented event, the American College of Obstetrics and Gynecology, the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic and unified changes in screening utilizing this new framework. No studies of significance have evaluated (since guideline change in 2013), whether primary care providers find the new recommendations authoritative and believe in them, or whether providers understand implementation of these new guidelines given the many decades of contradictory and differing recommendations. For this study, the opinions of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied. Using the California Medical Board database of licensed providers, a questionnaire will be mailed to a random subset. It is anticipated that the analysis will show varying contempt, confusion and compliance with new guidelines exists. Understanding these factors will have beneficial health policy implications in terms of overcoming barriers to these cost-effective, less intrusive, and more accurate health policy guidelines in the prevention and early detection of cervical cancer.
Read the detailed description
Cervical cancer remains a common cause of death and disability among women both within the United States and world-wide. Potential exists for significant prevention and early detection if cervical cancer screening is performed at the correct frequencies, with correct methods, on the appropriate women. Since the development of the Papanicolaou smear (Pap smear), cervical cancer screening has been recommended as a component of preventative healthcare for women. The tradition of an annual pap smear remains a common component of American medicine. For over four decades, controversy has existed as to the optimal method and timing of cervical cancer screening. The result has been great confusion amongst providers.
Significant developments have led to a dramatic change in recommendations for cervical cancer screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100% of cervical cancer cases and the development of new technologies for detection of HPV DNA at time of cervical cancer screening, has produced changes in preventive healthcare policy for this condition. In an unprecedented event, the American College of Obstetrics and Gynecology, the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic and unified changes in screening utilizing this new technology: In healthy women, A: do not start screening prior to age 21, B: screen every 3 years between ages 21-29, C: screen only every 5 years between ages 30-65, and D: stop any further screening for cervical cancer after 65. This significant reduction in the number of cervical cancer screenings is the result of these new technologies for the detection of the HPV virus, as well as evidence-based findings on the lack of risk for cancer in women who test negative for HPV. From a public health policy standpoint, the new recommendations are revolutionary. Whereas a women previously might have received 62 "Pap Smears" between the ages of 18-79, with new recommendations, only 6 cervical cancer screenings would be required over her lifetime.
Understanding these new recommendations and complying with these new unified recommendations would have a dramatic effect on health policy. The current multi-billion dollar cost of annual cervical cancer screening would be dramatically reduced. The time and physical inconvenience of this examination would be lessened. At a time when there is a great shortage of primary care providers (MD's, PA's and NP's) in many parts of the U.S., these dramatically reduced needs for cervical cancer screening might allow primary care providers greater time for more important health policy. No studies of significance have evaluated (since guideline change in 2013), whether primary care providers find the new recommendations authoritative and believe in them, or whether providers understand implementation of these new guidelines given the many decades of contradictory and differing recommendations.
The implications for health policy are significant:
- To the extent that primary care providers don't believe in the new guidelines, then providers should be educated on the evidence-based rationale from which they were constructed. In other words: to overcome whatever misgivings providers might harbor as to the new recommendations.
- To the extent that primary care providers believe in the new guidelines, but can't correctly apply them, then health policy would suggest an educational campaign to indicate correct application.
- To the extent that primary care providers harbor biases, further research to understand and develop strategies to overcome these biases would be indicated.
For this study, the opinions of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied. Using the California Medical Board database of licensed providers, a questionnaire will be mailed to a random subset. The sample will be randomized to include providers in both urban and rural areas of provider shortages, with a spectrum of patients of differing ethnic and economic status. It is anticipated that approximately 5,000 questionnaires will be mailed out with the goal of 1,000 responses.
The study will investigate the following issues: 1) Do primary care providers in these regions believe in these new and dramatically different guidelines? 2) Are the providers able to correctly apply these guidelines in four different clinical vignettes? 3) Do the providers hold a bias which may influence their willingness to follow these new guidelines? It is anticipated that the analysis will show varying contempt, confusion and compliance with new guidelines exists. Understanding these factors will have beneficial health policy implications in terms of overcoming barriers to these cost-effective, less intrusive, and more accurate health policy guidelines in the prevention and early detection of cervical cancer.
- Conditions
- Cervical Cancer
- Being tested
- Questionnaire
- 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.
QuestionnaireBehavioural
The Questionnaire aims to evaluate based on the responses if providers don't uniformly agree with the new guidelines, if they can't interpret them correctly, and or if they have personal biases towards the older guidelines based upon prior training, personal experience, financial incentives, etc.
| Study group | Role | What they receive |
|---|---|---|
| primary care providers by region | Experimental | A questionnaire will be given to a randomized sample of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Health Care Providers Beliefs Regarding Current Cervical Cancer Screening Guidelines
Questionnaire responses to clinical scenarios and assessments of current published clinical guidelines by ACOG, ACS or USPSTF
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lavona Lewis, University of Southern California
- Investigators
- Emily J Boone, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265120
- Sponsor's protocol ID
- UP-14-00447
- Status last verified
- Nov 2015
- First submitted
- 30 Sep 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Providers' Views and Understanding of Current Recommended Guidelines for Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT02265120
- Acronym / sponsor ID
- UP-14-00447
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Oct 2014 (estimated)
- 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.
Significant developments have led to a dramatic change in recommendations for cervical cancer screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100% of cervical cancer cases and the development of new technologies for detection of HPV DNA at time of cervical cancer screening, has produced changes in preventive healthcare policy for this condition. In an unprecedented event, the American College of Obstetrics and Gynecology, the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic and unified changes in screening utilizing this new framework. No studies of significance have evaluated (since guideline change in 2013), whether primary care providers find the new recommendations authoritative and believe in them, or whether providers understand implementation of these new guidelines given the many decades of contradictory and differing recommendations. For this study, the opinions of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied. Using the California Medical Board database of licensed providers, a questionnaire will be mailed to a random subset. It is anticipated that the analysis will show varying contempt, confusion and compliance with new guidelines exists. Understanding these factors will have beneficial health policy implications in terms of overcoming barriers to these cost-effective, less intrusive, and more accurate health policy guidelines in the prevention and early detection of cervical cancer.
Detailed description
Cervical cancer remains a common cause of death and disability among women both within the United States and world-wide. Potential exists for significant prevention and early detection if cervical cancer screening is performed at the correct frequencies, with correct methods, on the appropriate women. Since the development of the Papanicolaou smear (Pap smear), cervical cancer screening has been recommended as a component of preventative healthcare for women. The tradition of an annual pap smear remains a common component of American medicine. For over four decades, controversy has existed as to the optimal method and timing of cervical cancer screening. The result has been great confusion amongst providers.
Significant developments have led to a dramatic change in recommendations for cervical cancer screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100% of cervical cancer cases and the development of new technologies for detection of HPV DNA at time of cervical cancer screening, has produced changes in preventive healthcare policy for this condition. In an unprecedented event, the American College of Obstetrics and Gynecology, the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic and unified changes in screening utilizing this new technology: In healthy women, A: do not start screening prior to age 21, B: screen every 3 years between ages 21-29, C: screen only every 5 years between ages 30-65, and D: stop any further screening for cervical cancer after 65. This significant reduction in the number of cervical cancer screenings is the result of these new technologies for the detection of the HPV virus, as well as evidence-based findings on the lack of risk for cancer in women who test negative for HPV. From a public health policy standpoint, the new recommendations are revolutionary. Whereas a women previously might have received 62 "Pap Smears" between the ages of 18-79, with new recommendations, only 6 cervical cancer screenings would be required over her lifetime.
Understanding these new recommendations and complying with these new unified recommendations would have a dramatic effect on health policy. The current multi-billion dollar cost of annual cervical cancer screening would be dramatically reduced. The time and physical inconvenience of this examination would be lessened. At a time when there is a great shortage of primary care providers (MD's, PA's and NP's) in many parts of the U.S., these dramatically reduced needs for cervical cancer screening might allow primary care providers greater time for more important health policy. No studies of significance have evaluated (since guideline change in 2013), whether primary care providers find the new recommendations authoritative and believe in them, or whether providers understand implementation of these new guidelines given the many decades of contradictory and differing recommendations.
The implications for health policy are significant:
- To the extent that primary care providers don't believe in the new guidelines, then providers should be educated on the evidence-based rationale from which they were constructed. In other words: to overcome whatever misgivings providers might harbor as to the new recommendations.
- To the extent that primary care providers believe in the new guidelines, but can't correctly apply them, then health policy would suggest an educational campaign to indicate correct application.
- To the extent that primary care providers harbor biases, further research to understand and develop strategies to overcome these biases would be indicated.
For this study, the opinions of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied. Using the California Medical Board database of licensed providers, a questionnaire will be mailed to a random subset. The sample will be randomized to include providers in both urban and rural areas of provider shortages, with a spectrum of patients of differing ethnic and economic status. It is anticipated that approximately 5,000 questionnaires will be mailed out with the goal of 1,000 responses.
The study will investigate the following issues: 1) Do primary care providers in these regions believe in these new and dramatically different guidelines? 2) Are the providers able to correctly apply these guidelines in four different clinical vignettes? 3) Do the providers hold a bias which may influence their willingness to follow these new guidelines? It is anticipated that the analysis will show varying contempt, confusion and compliance with new guidelines exists. Understanding these factors will have beneficial health policy implications in terms of overcoming barriers to these cost-effective, less intrusive, and more accurate health policy guidelines in the prevention and early detection of cervical cancer.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primary care providers by region | Experimental | Behavioral: QuestionnaireA questionnaire will be given to a randomized sample of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care providers who care for patients within the 194 federally designated regions of Primary Care provider shortage within California
Key exclusion criteria (1 listed)
- Outside of federally designated region of Primary Care provider shortage within California
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 |
|---|---|---|
| QuestionnaireThe Questionnaire aims to evaluate based on the responses if providers don't uniformly agree with the new guidelines, if they can't interpret them correctly, and or if they have personal biases towards the older guidelines based upon prior training, personal experience, financial incentives, etc. | Behavioural | primary care providers by region |
Primary outcome
Primary Health Care Providers Beliefs Regarding Current Cervical Cancer Screening Guidelines
Time frame: 5 months
Questionnaire responses to clinical scenarios and assessments of current published clinical guidelines by ACOG, ACS or USPSTF
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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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.
Emily J Boone principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Cervical Cancer, run by University of Southern California 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Dec 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Health Care Providers Beliefs Regarding Current Cervical Cancer Screening Guidelines (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2015.