Cervical Cancer ScreeningNCT04658888
St. Joe's Invitation Effectiveness Study
A study testing Evalyn Self-Sampling Brush in people with Cervical Cancer Screening, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The objective of this study is to evaluate the effectiveness of offering self-sampling for high risk human papilloma virus (HPV) testing in order to increase the number of women who are screened for cervical cancer. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Evalyn Self-Sampling Brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 964 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients at Penn State Health St. Joe's Family and Community Medicine residency clinic or women's health clinic.
- Ages 30-65 years
- Out-of-date for cervical cancer screening
- Able to speak, read, and communicate well in English or Spanish
- Not greater than average risk for cervical cancer screening
Who cannot join
- Pregnant
- Incarcerated
- Greater than average risk for cervical cancer (2)
- Have a compromised immune system
- With in-utero exposure to diethylstilbestrol
- Unable to speak, read, and communicate well in English or Spanish
- Unable or unwilling to give implied consent or otherwise complete study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: Increasing Cervical Cancer Screening Among Female Patients at Penn State Health St. Joe's Residency Clinic: Letter Notifying Them About Outdated Screen and Postcard With Self-sampling Option
The objective of this study is to evaluate the effectiveness of offering self-sampling for high risk human papilloma virus (HPV) testing in order to increase the number of women who are screened for cervical cancer. The hypothesis of this study is that women who are notified of a need for cervical cancer screening by letter and are also offered a self-sampling kit for cervical cancer screening will have a higher rate of screening than women notified by letter alone.
This study will use an intervention arm (letter and option to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the control arm and 1 to the intervention arm). The primary endpoint that will be evaluated in this study is the method of completion of cervical cancer screening and the use of the self-sampling kit, which will be monitored over a three month period after the letters have been mailed. A secondary endpoint will be the overall rate of cervical cancer screening of all people mailed a letter.
Read the detailed description
The American Cancer Society estimates that 4,170 women in the United States will die from cervical cancer in 2018. It is possible to prevent many of these deaths through screening and appropriate follow-up in women with positive screens (1). Self-sampling for HPV testing may be a viable option for cervical cancer screening, particularly among women who do not obtain regular screening in a clinical setting.
The objective of this study is to evaluate the effectiveness of offering self-sampling for high risk HPV testing to in order to increase the number of women who are screened for cervical cancer at the Penn State Health (PSH) St. Joseph's family and community medicine residency clinic. This study will use an intervention arm and a control arm. Women in the control arm will receive a standard letter stating that they need to be screened and should contact their primary care provider. Women in the intervention arm will receive a modified version of the letter informing them of a self-sampling option with a pre-addressed post card that allows them to request a self-sampling kit. Once the postcard is returned these women will receive a self-sampling kit in the mail to collect their sample. The kit will come with a pre-paid mailer so that the participant can return their kit for processing at the Penn State Hershey Clinical laboratory.
Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record by the use of a set of queries that have been developed to extract this patient population. Eligible women will be randomized to the study group in a 2 to 1 ratio (2 for the control arm and 1 to the intervention arm). The primary endpoint that will be evaluated in this study is the method of completion of cervical cancer screening and the use of the self-sampling kit, which will be monitored over a three month period after the letters have been mailed. A secondary endpoint will be the overall rate of cervical cancer screening of all people mailed a letter. Participants will be recruited continuously until the anticipated sample size has been met. A total of 1,211 participants are expected to participate in this study, 807 in the control arm and 404 in the intervention arm. The study team will calculate the proportion of participants who obtain cervical cancer screening from the clinic or the self-sampling kit and use chi-square tests for statistical analysis.
If a self-collected cervical sample produces a negative result, the participant will be contacted by a study physician with these results. If the sample produces a positive result for low-risk HPV the participant will be contacted by a study physician to schedule a pap test. If the sample produces a positive result for high-risk HPV the participant will be contacted by a study physician for a colposcopy. The pap test and colposcopy are both standard of care for these results. The study team will monitor the completion of the screenings and subsequent procedures.
- Conditions
- Cervical Cancer Screening
- Being tested
- Evalyn Self-Sampling Brush
- Keywords
- Cervical Cancer, Self-Sampling
- 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.
Evalyn Self-Sampling BrushDevice
A self-sampling brush to collect cervical cancer cells for screening purposes.
| Study group | Role | What they receive |
|---|---|---|
| Modified letter with self-sampling request card | Experimental | This group will receive a modified letter telling the participant they are out of date with their cervical cancer screening. They will also receive information on the self-sampling kit and will be provided a card that they can send back to the study team in order to have a kit sent to their house. The kit will include a pre-paid mailer so that it can be sent back to the lab for testing. The result will then be shared with the participant. Receives: Device: Evalyn Self-Sampling Brush |
| Standard letter | No intervention | Participants will receive a standard of care letter that tells the participant they are out of date with their cervical cancer screening and should contact their primary care provider to schedule an appointment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Cervical Cancer Screening
To compare the percentage of cervical cancer screenings completed in the control group who received a standard letter with the percentage of cervical cancer screenings completed in the intervention group who receive a modified letter with a self-sampling option.
Measured: Three months after the letter is sent.
Use of the Self-sampling Kit
Evaluate the number of participants request and use the self-sampling kit in the intervention group.
Measured: Three months after the letter is sent
Secondary outcomes (1)
Overall Rate of Cervical Cancer Screening Over Both the Control and Intervention Group
Overall rate of cervical cancer screenings for both the control group and the intervention group.
Measured: Three months after the letter is sent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start26 Apr 2021
- Primary completion1 Dec 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Cancer ScreeningStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a two armed model: an intervention and a control arm. The control arm will use a standard of care letter reminding the participant to schedule their screening with their primary care provider. The intervention arm will consist of a modified letter with a postcard giving the participant the option to request a self-sampling kit.
- Masking
- None (open label)
- Enrolment
- 964 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Scartozzi, Milton S. Hershey Medical Center
- Investigators
- Christina Scartozzi, DO, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658888
- Sponsor's protocol ID
- 14823
- Status last verified
- Jun 2022
- First submitted
- 30 Nov 2020
- Last updated
- 6 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
PubMed 29313949US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Aug 21;320(7):674-686. doi: 10.1001/jama.2018.10897.
PubMed 30140884
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Cervical Cancer Screening Among Female Patients at Penn State Health St. Joe's Residency Clinic: Letter Notifying Them About Outdated Screen and Postcard With Self-sampling Option
- ClinicalTrials.gov ID
- NCT04658888
- Acronym / sponsor ID
- 14823
- Conditions
- Cervical Cancer Screening
- Keywords
- Cervical Cancer, Self-Sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 964 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Posted 6 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effectiveness of offering self-sampling for high risk human papilloma virus (HPV) testing in order to increase the number of women who are screened for cervical cancer. The hypothesis of this study is that women who are notified of a need for cervical cancer screening by letter and are also offered a self-sampling kit for cervical cancer screening will have a higher rate of screening than women notified by letter alone.
This study will use an intervention arm (letter and option to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the control arm and 1 to the intervention arm). The primary endpoint that will be evaluated in this study is the method of completion of cervical cancer screening and the use of the self-sampling kit, which will be monitored over a three month period after the letters have been mailed. A secondary endpoint will be the overall rate of cervical cancer screening of all people mailed a letter.
Detailed description
The American Cancer Society estimates that 4,170 women in the United States will die from cervical cancer in 2018. It is possible to prevent many of these deaths through screening and appropriate follow-up in women with positive screens (1). Self-sampling for HPV testing may be a viable option for cervical cancer screening, particularly among women who do not obtain regular screening in a clinical setting.
The objective of this study is to evaluate the effectiveness of offering self-sampling for high risk HPV testing to in order to increase the number of women who are screened for cervical cancer at the Penn State Health (PSH) St. Joseph's family and community medicine residency clinic. This study will use an intervention arm and a control arm. Women in the control arm will receive a standard letter stating that they need to be screened and should contact their primary care provider. Women in the intervention arm will receive a modified version of the letter informing them of a self-sampling option with a pre-addressed post card that allows them to request a self-sampling kit. Once the postcard is returned these women will receive a self-sampling kit in the mail to collect their sample. The kit will come with a pre-paid mailer so that the participant can return their kit for processing at the Penn State Hershey Clinical laboratory.
Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record by the use of a set of queries that have been developed to extract this patient population. Eligible women will be randomized to the study group in a 2 to 1 ratio (2 for the control arm and 1 to the intervention arm). The primary endpoint that will be evaluated in this study is the method of completion of cervical cancer screening and the use of the self-sampling kit, which will be monitored over a three month period after the letters have been mailed. A secondary endpoint will be the overall rate of cervical cancer screening of all people mailed a letter. Participants will be recruited continuously until the anticipated sample size has been met. A total of 1,211 participants are expected to participate in this study, 807 in the control arm and 404 in the intervention arm. The study team will calculate the proportion of participants who obtain cervical cancer screening from the clinic or the self-sampling kit and use chi-square tests for statistical analysis.
If a self-collected cervical sample produces a negative result, the participant will be contacted by a study physician with these results. If the sample produces a positive result for low-risk HPV the participant will be contacted by a study physician to schedule a pap test. If the sample produces a positive result for high-risk HPV the participant will be contacted by a study physician for a colposcopy. The pap test and colposcopy are both standard of care for these results. The study team will monitor the completion of the screenings and subsequent procedures.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a two armed model: an intervention and a control arm. The control arm will use a standard of care letter reminding the participant to schedule their screening with their primary care provider. The intervention arm will consist of a modified letter with a postcard giving the participant the option to request a self-sampling kit.
| Arm | Type | Receives |
|---|---|---|
| Modified letter with self-sampling request card | Experimental | Device: Evalyn Self-Sampling BrushThis group will receive a modified letter telling the participant they are out of date with their cervical cancer screening. They will also receive information on the self-sampling kit and will be provided a card that they can send back to the study team in order to have a kit sent to their house. The kit will include a pre-paid mailer so that it can be sent back to the lab for testing. The result will then be shared with the participant. |
| Standard letter | No intervention | –Participants will receive a standard of care letter that tells the participant they are out of date with their cervical cancer screening and should contact their primary care provider to schedule an appointment. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients at Penn State Health St. Joe's Family and Community Medicine residency clinic or women's health clinic.
- Ages 30-65 years
- Out-of-date for cervical cancer screening
- Able to speak, read, and communicate well in English or Spanish
- Not greater than average risk for cervical cancer screening
Key exclusion criteria (7 listed)
- Pregnant
- Incarcerated
- Greater than average risk for cervical cancer (2)
- Have a compromised immune system
- With in-utero exposure to diethylstilbestrol
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 |
|---|---|---|
| Evalyn Self-Sampling BrushA self-sampling brush to collect cervical cancer cells for screening purposes. | Device | Modified letter with self-sampling request card |
Primary outcome
Percentage of Cervical Cancer Screening
Time frame: Three months after the letter is sent.
To compare the percentage of cervical cancer screenings completed in the control group who received a standard letter with the percentage of cervical cancer screenings completed in the intervention group who receive a modified letter with a self-sampling option.
Use of the Self-sampling Kit
Time frame: Three months after the letter is sent
Evaluate the number of participants request and use the self-sampling kit in the intervention group.
1 secondary outcome
Overall Rate of Cervical Cancer Screening Over Both the Control and Intervention Group
Time frame: Three months after the letter is sent
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29313949Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
- Background: PubMed 30140884US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Aug 21;320(7):674-686. doi: 10.1001/jama.2018.10897.
- 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.
Christina Scartozzi, DO principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evalyn Self-Sampling Brush in people with Cervical Cancer Screening, run by Milton S. Hershey Medical Center 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: finished, as of the sponsor's last update on 6 Jul 2022. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Cervical Cancer Screening (time frame: Three months after the letter is sent.). The study lists 2 primary outcomes in all. 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 NCT04658888, which also lists 2 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 6 Jul 2022.