NCT04471194

Multilevel Intervention Based on Colorectal Cancer (CRC) and Cervical Cancer Self-screening in Rural, Segregated Areas

Multilevel Intervention Based on CRC and Cervical Cancer Self-screening in Rural, Segregated Areas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: 50 Years – 65 Years
• Healthy volunteers: Accepted

Summary

In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of Pennsylvania. The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted educational materials, to women in rural, segregated areas could help increase cancer screening, reduce geographic cancer disparities, and improve public health.

Detailed description

In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of Pennsylvania. A control group of 110 women, also recruited through FQHCs in rural, segregated counties of Pennsylvania, will be used for comparison; these women will receive standard-of-care reminders for cancer screening and complete the baseline and follow-up surveys. The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted educational materials, to women in rural, segregated areas could help increase cancer screening, reduce geographic cancer disparities, and improve public health.

Conditions

• Colorectal Cancer Screening
• Cervical Cancer Screening

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Self-sampling HPV test	Tests for human papillomavirus from cervical cell sample
DIAGNOSTIC_TEST	Fecal occult blood test	Tests for human hemoglobin from blood in fecal samples

Timeline

• Start date: 2021-02-18
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2020-07-15
• Last updated: 2022-12-13
• Results posted: 2022-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study