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Completed

NCT Number: NCT04471194

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

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

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Key information

Conditions

Colorectal Cancer Screening Cervical Cancer Screening

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

About this study

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • out of date for both cervical and colorectal cancer screening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

Treatment and study plan

Self-sampling HPV test

Diagnostic Test

Tests for human papillomavirus from cervical cell sample

Other names: Evalyn® Brush

Fecal occult blood test

Diagnostic Test

Tests for human hemoglobin from blood in fecal samples

Other names: InSure® test

Primary outcomes

  1. Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests

    Time frame: 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 outcomes

  1. Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2020
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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