St. Joe's Invitation Effectiveness Study

Study Overview
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Brief Summary
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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to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the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
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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.

Official Title
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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

Conditions
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Cervical Cancer Screening

Intervention / Treatment
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* Device: Evalyn Self-Sampling Brush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified letter with self-sampling request card<br>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. | Device: Evalyn Self-Sampling Brush<br>* A self-sampling brush to collect cervical cancer cells for screening purposes.<br>|
| No Intervention: Standard letter<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Three months after the letter is sent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Three months after the letter is sent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Cancer, Self-Sampling