Clinical trial NCT04471194: Multilevel Intervention Based on Colorectal Cancer (CRC) and Cervical Cancer Self-screening in Rural, Segregated Areas
Official title: Multilevel Intervention Based on CRC and Cervical Cancer Self-screening in Rural, Segregated Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Cervical Cancer Screening
Keywords: Environmental barriers to cancer screening
Person-level barriers to cancer screening
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-15
Enrollment: 48
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests
timeFrame: 10 weeks
Secondary outcomes:
measure: Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Jennifer Moss, PhD
role: PRINCIPAL_INVESTIGATOR
References: