St. Joe's Invitation Effectiveness Study

NCT04658888 | Completed Results FDA Device

• 1 other identifier: 14823
• Study Type: interventional
• Target: 964
• Locations: 1 country
• Sites: 1

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to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the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

Conditions

Cervical Cancer Screening

Keywords

Cervical Cancer; Self-Sampling

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Overall Rate of Cervical Cancer Screening Over Both the Control and Intervention Group

  Three months after the letter is sent

Study Arms (2)

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This group will receive a modified letter telling the participant they are out of date with their cervical cancer screening.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.

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.

Interventions

Evalyn Self-Sampling Brush DEVICE

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

Modified letter with self-sampling request card

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

• 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.

  PMID: 29313949 BACKGROUND

• 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.

  PMID: 30140884 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Dr. Christina Scartozzi
• Organization: Penn State Health Milton S Hershey Medical Center

Cscartozzi@pennstatehealth.psu.edu

484-650-0885

Study Officials

• Christina Scartozzi, DO

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 9, 2020
• Study Start: April 26, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: July 6, 2022
• Results First Posted: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)