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

November 18, 2022 updated by: Jennifer L. Moss, PhD, Milton S. Hershey Medical Center

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Sampling Intervention
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
Tests for human papillomavirus from cervical cell sample
Other Names:
  • Evalyn® Brush
Diagnostic test: Fecal occult blood test
Tests for human hemoglobin from blood in fecal samples
Other Names:
  • InSure® test
No Intervention: Control
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jennifer Moss, PhD, Penn State College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

July 4, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00015480
  • K22CA225705-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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