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

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

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

Conditions
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Colorectal Cancer Screening, Cervical Cancer Screening

Intervention / Treatment
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* Diagnostic Test: Self-sampling HPV test
* Diagnostic Test: Fecal occult blood test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Sampling Intervention<br>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. | Diagnostic Test: Self-sampling HPV test<br>* Tests for human papillomavirus from cervical cell sample<br>* Other names: Evalyn® Brush;Diagnostic Test: Fecal occult blood test<br>* Tests for human hemoglobin from blood in fecal samples<br>* Other names: InSure® test;|
| No Intervention: Control<br>Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Environmental barriers to cancer screening, Person-level barriers to cancer screening