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

Primary Purpose

Colorectal Cancer Screening, Cervical Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-sampling HPV test
Fecal occult blood test
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer Screening focused on measuring Environmental barriers to cancer screening, Person-level barriers to cancer screening

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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  • out of date for both cervical and colorectal cancer screening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

Sites / Locations

  • Penn State College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-Sampling Intervention

Control

Arm 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.

Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 4, 2020
Last Updated
November 18, 2022
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04471194
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening, Cervical Cancer Screening
Keywords
Environmental barriers to cancer screening, Person-level barriers to cancer screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Sampling Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Self-sampling HPV test
Other Intervention Name(s)
Evalyn® Brush
Intervention Description
Tests for human papillomavirus from cervical cell sample
Intervention Type
Diagnostic Test
Intervention Name(s)
Fecal occult blood test
Other Intervention Name(s)
InSure® test
Intervention Description
Tests for human hemoglobin from blood in fecal samples
Primary Outcome Measure Information:
Title
Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Moss, PhD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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