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

Not Applicable

Completed

• Conditions: Colorectal Cancer Screening; Cervical Cancer Screening
• Interventions: Diagnostic Test: Self-sampling HPV test; Diagnostic Test: Fecal occult blood test

• Registration Number: NCT04471194
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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immunochemical test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of Pennsylvania.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immunochemical test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of Pennsylvania.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.

Study Timeline

• Study First Submitted: 2020-07-04
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-15
• Study Start: 2021-02-18
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Results First Submitted: 2022-09-20
• Results First Submitted QC: 2022-09-20
• Results First Posted: 2022-10-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• lives in rural, segregated county of Pennsylvania
• able to speak, read, and communicate well in English
• out of date for both cervical and colorectal cancer screening

Exclusion Criteria

• has had a partial or complete hysterectomy
• has a family history of colorectal cancer
• has a personal history of cervical or colorectal cancer
• persons who are cognitively impaired
• persons who are incarcerated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Sampling Intervention	Self-sampling HPV test	Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer.
Self-Sampling Intervention	Fecal occult blood test	Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer.

Primary Outcome Measures

Name	Time	Method
Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests	10 weeks	Difference in percentage of participants who self-report having had cervical cancer screening PLUS having had colorectal cancer screening (all modalities) by the end of the study period between the two arms.

Secondary Outcome Measures

Name	Time	Method
Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests	10 weeks	Difference in percentage of participants who completed at-home cervical cancer screening test PLUS completed at-home colorectal cancer screening test by the end of the study period between the two arms.

Trial Locations

Locations (1)

Penn State College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States