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NCT04471194 Clinical Trial

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

Colorectal Cancer Screening Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04471194
Other study ID # STUDY00015480
Secondary ID K22CA225705-01A1
Status Completed
Phase N/A
First received
Last updated
Start date February 18, 2021
Est. completion date March 1, 2022

Study information
Verified date November 2022
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Self-sampling HPV test
Tests for human papillomavirus from cervical cell sample
• Fecal occult blood test
Tests for human hemoglobin from blood in fecal samples

Locations
Country Name City State
United States Penn State College of Medicine Hershey Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Milton S. Hershey Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests 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. 10 weeks
Secondary Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests 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. 10 weeks
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