Cervical CancerNCT02270021
Decreasing Over Screening and Treatment of Cervical Precancers in Young Women
A study testing Provider Mobile Application (ProvAPP) and ProvAPP + Patient Educational Tool (Tab) in people with Cervical Cancer, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The goal of this study is to prevent over screening and over treatment of young women for cervical precancers, which can result in psychological distress and has been associated with future risk of premature deliveries. Read more about this study
- Who is it for?
- Ages 21 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Provider Mobile Application (ProvAPP) and ProvAPP + Patient Educational Tool (Tab)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jul 2014to 30 Aug 2019
- 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 21 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- English or Spanish speaking
- Women
- Age 21-29 years
- History of one or more of the following: abnormal Pap smear, normal Pap smear, no Pap smear, cervical cancer
- Family PACT provider
- Not a Planned Parenthood affiliate
Show all 10Show fewer
- Located in one of ten identified Southern California study counties
- Sends cytology/histology specimens to Quest Diagnostics West Hills
- Clinical care visits occurred to at least 200 women age 21-29 years in fiscal year 2011/2012
- Has a calculated average cytology interval of less than 30 months (based on last three years)
Who cannot join
- Language other than English or Spanish
- Male
- Younger than 21 or older than 29
- Not a Family PACT provider
- Planned Parenthood affiliate
- Not located in one of ten identified Southern California study counties
Show all 9Show fewer
- Sends cytology/histology specimens to a lab other than Quest Diagnostics West Hills
- Clinical care visit occurred to less than 200 women age 21-29
- Has a calculated average cytology interval of more than 30 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Los Angeles
Los Angeles, California, 90095
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Randomized Trial to Increase Adherence to Cervical Cancer Screening Guidelines for Young Women
The goal of this study is to prevent over screening and over treatment of young women for cervical precancers, which can result in psychological distress and has been associated with future risk of premature deliveries. Current national guidelines recommend that routine screening be performed at less-frequent intervals and that excisional cervical therapies are discouraged in young women. The objectives of this study are to examine physician- and patient-based interventions designed to decrease over screening and over treatment by increasing adherence to US guidelines for women under 30 years.
Read the detailed description
In this study, we compare two different intervention arms that are designed to prevent over screening and over treatment by increasing adherence to the new US cervical cancer screening guidelines and the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Specifically, the interventions will focus on the newly recommended cervical cancer screening intervals and decreasing the number of colposcopy procedures and cervical procedures for abnormal cytology.
This is a cluster randomized trial with individual clinics serving as the clusters. Clinics from the California Family PACT provider network who serve at least 200 female clients per year under 30 years of age will be randomized to one of two arms: 1) ASCCP mobile application (ProvAPP)-based intervention for providers, or 2) ProvAPP + Patient education Tool (Tab) intervention. These groups will be compared to a control comparison group of 28 clinics chosen using propensity score matching based on clinic characteristics such as county and private versus public from the Family PACT claims data. The ProvAPP intervention is for clinicians' mobile phones and will help them maneuver through current guidelines based on patient age and condition. An existing application from the ASCCP will be updated to include screening guidelines and to be more user-friendly. The patient-based Tab intervention will be a patient education tool accessible via URL on a tablet device at the time of check-in to assist in asking questions and evaluating treatment options. The tool will be developed with input from women age 21-29 as well as other stakeholders including Latinas Contra Cancer and the National Cervical Cancer Coalition. It is hypothesized that the ProvAPP+Tab approach will be most successful; all interventions will be more successful than no intervention.
Family PACT serves predominantly uninsured women and 40% of clients are Latina. We plan to enroll 7 sites (ProvAPP) and 7 sites (ProvAPP+Tab) into the other intervention arm with an average of 2,800 women to 3,500 women aged 21-29 years per arm (14 sites) with a similar number of sites and women randomly chosen for the comparison arm (28 sites) resulting in a total of 39 sites and 8,400-10,500 women. We will use Family PACT claims data to examine, by age, the number of and average interval between cytology specimens, colposcopy examinations, and the number of excisional procedures.
- Conditions
- Cervical Cancer
- Being tested
- Provider Mobile Application (ProvAPP), ProvAPP + Patient Educational Tool (Tab)
- Keywords
- Pap smear, Screening, Women, Human papillomavirus, Cervical precancer, Guideline adherence
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider Mobile Application (ProvAPP)Other
Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition.
ProvAPP + Patient Educational Tool (Tab)Other
Patient Educational Tool (Tab): A patient educational tool (mobile tablet) will educate women on cervical cancer screening and treatment. Patients' self-assessment using a tablet at the time of clinic check-in will help them to understand current guidelines and their choices for treatment if they have abnormal cytology. It will allow them to assess the risks and benefits of screening intervals and of treatment choices.
ProvAPP: Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition.
| Study group | Role | What they receive |
|---|---|---|
| Provider Mobile Application (ProvAPP) | Experimental | Mobile phone application for providers. Receives: Other: Provider Mobile Application (ProvAPP) |
| ProvAPP + Patient Educational Tool (Tab) | Experimental | Patient educational tool; plus the Mobile phone application for providers. Receives: Other: ProvAPP + Patient Educational Tool (Tab) |
| ProvAPP Control Group | No intervention | Clinics in this group are those NOT randomized - receiving no intervention. These clinics will be chosen at random for comparison using Family PACT claims data. |
| ProvAPP+Tab Control Group | No intervention | Clinics in this group are those NOT randomized - receiving no intervention. These clinics will be chosen at random for comparison using Family PACT claims data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Cervical Cancer Screening
Rate of women 21-29 years who received cervical cytology tests.
Measured: Change from baseline screening rate (3 months prior to intervention) to 15-18 months after start of intervention
Secondary outcomes (1)
Rate of Colposcopy
Rate of women 21-29 years who receive colposcopy for cervical cancer screening over the total number of women 21-29 years.
Measured: Change from baseline colposcopy rate (3 months prior to intervention) to 15-18 months after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study start24 Jul 2014
- Primary completion30 Apr 2018
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- clinic sites were randomized not subjects
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Latinas Contra Cancer, National Cervical Cancer Coalition, California Department of Health Services, American College of Obstetricians and Gynecologists, American Society for Colposcopy and Cervical Pathology
- Responsible party
- Sponsor
- Investigators
- Anna-Barbara Moscicki, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270021
- Sponsor's protocol ID
- 13-12257
- Other IDs
- CD-1304-6551
- Status last verified
- Sep 2019
- First submitted
- 14 Oct 2014
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moscicki AB, Chang C, Vangala S, Zhou X, Elashoff DA, Dehlendorf C, Sawaya GF, Kuppermann M, Duron Y, Wyand FL, Navarro SK, Thiel de Bocanegra H. Effect of 2 Interventions on Cervical Cancer Screening Guideline Adherence. Am J Prev Med. 2021 May;60(5):666-673. doi: 10.1016/j.amepre.2020.11.015. Epub 2021 Feb 23.
PubMed 33632649
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Increase Adherence to Cervical Cancer Screening Guidelines for Young Women
- ClinicalTrials.gov ID
- NCT02270021
- Acronym / sponsor ID
- 13-12257
- Conditions
- Cervical Cancer
- Keywords
- Pap smear, Screening, Women, Human papillomavirus, Cervical precancer, Guideline adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Latinas Contra Cancer, National Cervical Cancer Coalition, California Department of Health Services, American College of Obstetricians and Gynecologists, American Society for Colposcopy and Cervical Pathology
- Study start
- 24 Jul 2014 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 21 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.
The goal of this study is to prevent over screening and over treatment of young women for cervical precancers, which can result in psychological distress and has been associated with future risk of premature deliveries. Current national guidelines recommend that routine screening be performed at less-frequent intervals and that excisional cervical therapies are discouraged in young women. The objectives of this study are to examine physician- and patient-based interventions designed to decrease over screening and over treatment by increasing adherence to US guidelines for women under 30 years.
Detailed description
In this study, we compare two different intervention arms that are designed to prevent over screening and over treatment by increasing adherence to the new US cervical cancer screening guidelines and the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Specifically, the interventions will focus on the newly recommended cervical cancer screening intervals and decreasing the number of colposcopy procedures and cervical procedures for abnormal cytology.
This is a cluster randomized trial with individual clinics serving as the clusters. Clinics from the California Family PACT provider network who serve at least 200 female clients per year under 30 years of age will be randomized to one of two arms: 1) ASCCP mobile application (ProvAPP)-based intervention for providers, or 2) ProvAPP + Patient education Tool (Tab) intervention. These groups will be compared to a control comparison group of 28 clinics chosen using propensity score matching based on clinic characteristics such as county and private versus public from the Family PACT claims data. The ProvAPP intervention is for clinicians' mobile phones and will help them maneuver through current guidelines based on patient age and condition. An existing application from the ASCCP will be updated to include screening guidelines and to be more user-friendly. The patient-based Tab intervention will be a patient education tool accessible via URL on a tablet device at the time of check-in to assist in asking questions and evaluating treatment options. The tool will be developed with input from women age 21-29 as well as other stakeholders including Latinas Contra Cancer and the National Cervical Cancer Coalition. It is hypothesized that the ProvAPP+Tab approach will be most successful; all interventions will be more successful than no intervention.
Family PACT serves predominantly uninsured women and 40% of clients are Latina. We plan to enroll 7 sites (ProvAPP) and 7 sites (ProvAPP+Tab) into the other intervention arm with an average of 2,800 women to 3,500 women aged 21-29 years per arm (14 sites) with a similar number of sites and women randomly chosen for the comparison arm (28 sites) resulting in a total of 39 sites and 8,400-10,500 women. We will use Family PACT claims data to examine, by age, the number of and average interval between cytology specimens, colposcopy examinations, and the number of excisional procedures.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- clinic sites were randomized not subjects
| Arm | Type | Receives |
|---|---|---|
| Provider Mobile Application (ProvAPP) | Experimental | Other: Provider Mobile Application (ProvAPP)Mobile phone application for providers. |
| ProvAPP + Patient Educational Tool (Tab) | Experimental | Other: ProvAPP + Patient Educational Tool (Tab)Patient educational tool; plus the Mobile phone application for providers. |
| ProvAPP Control Group | No intervention | –Clinics in this group are those NOT randomized - receiving no intervention. These clinics will be chosen at random for comparison using Family PACT claims data. |
| ProvAPP+Tab Control Group | No intervention | –Clinics in this group are those NOT randomized - receiving no intervention. These clinics will be chosen at random for comparison using Family PACT claims data. |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- English or Spanish speaking
- Women
- Age 21-29 years
- History of one or more of the following: abnormal Pap smear, normal Pap smear, no Pap smear, cervical cancer
- Family PACT provider
Key exclusion criteria (9 listed)
- Language other than English or Spanish
- Male
- Younger than 21 or older than 29
- Not a Family PACT provider
- Planned Parenthood affiliate
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 |
|---|---|---|
| Provider Mobile Application (ProvAPP)Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition. | Other | Provider Mobile Application (ProvAPP) |
| ProvAPP + Patient Educational Tool (Tab)Patient Educational Tool (Tab): A patient educational tool (mobile tablet) will educate women on cervical cancer screening and treatment. Patients' self-assessment using a tablet at the time of clinic check-in will help them to understand current guidelines and their choices for treatment if they have abnormal cytology. It will allow them to assess the risks and benefits of screening intervals and of treatment choices. ProvAPP: Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition. | Other | ProvAPP + Patient Educational Tool (Tab) |
Primary outcome
Rate of Cervical Cancer Screening
Time frame: Change from baseline screening rate (3 months prior to intervention) to 15-18 months after start of intervention
Rate of women 21-29 years who received cervical cytology tests.
1 secondary outcome
Rate of Colposcopy
Time frame: Change from baseline colposcopy rate (3 months prior to intervention) to 15-18 months after start of intervention
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 25 Sep 2019.
- Derived from this study: PubMed 33632649Moscicki AB, Chang C, Vangala S, Zhou X, Elashoff DA, Dehlendorf C, Sawaya GF, Kuppermann M, Duron Y, Wyand FL, Navarro SK, Thiel de Bocanegra H. Effect of 2 Interventions on Cervical Cancer Screening Guideline Adherence. Am J Prev Med. 2021 May;60(5):666-673. doi: 10.1016/j.amepre.2020.11.015. Epub 2021 Feb 23.
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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.
Anna-Barbara Moscicki, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Mobile Application (ProvAPP) and ProvAPP + Patient Educational Tool (Tab) in people with Cervical Cancer, run by University of California, San Francisco at 2 sites 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 10 inclusion and 9 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Rate of Cervical Cancer Screening (time frame: Change from baseline screening rate (3 months prior to intervention) to 15-18 months after start of intervention). 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 NCT02270021, which also lists 1 linked publication.
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 25 Sep 2019.