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

Penn State Health

Status: Completed

Conditions: Cervical Cancer Screening; Colorectal Cancer Screening

Treatments: Diagnostic Test: Self-sampling HPV test; Diagnostic Test: Fecal occult blood test

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04471194

K22CA225705-01A1 (U.S. NIH Grant/Contract)

STUDY00015480

Details and patient eligibility

About

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

Enrollment: 48 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• out of date for both cervical and colorectal cancer screening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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Self-Sampling Intervention

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Fecal occult blood test

Diagnostic Test: Self-sampling HPV test

Control

No Intervention group

Description:

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.