St. Joe's Invitation Effectiveness Study

NCT ID: NCT04658888

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 964 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2022-02-01

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to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the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

Conditions

Cervical Cancer Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Modified letter with self-sampling request card

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.

Group Type: EXPERIMENTAL

Evalyn Self-Sampling Brush

Intervention Type: DEVICE

A self-sampling brush to collect cervical cancer cells for screening purposes.

Standard letter

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Evalyn Self-Sampling Brush

A self-sampling brush to collect cervical cancer cells for screening purposes.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christina Scartozzi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Scartozzi, DO

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

Penn State College of Medicine

Hershey, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29313949 (View on PubMed)

US 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.

Reference Type: BACKGROUND

PMID: 30140884 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14823

Identifier Type: -

Identifier Source: org_study_id