NCT04471194

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test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 18, 2022

Completed
Last Updated

December 13, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

July 4, 2020

Results QC Date

September 20, 2022

Last Update Submit

November 18, 2022

Conditions

Colorectal Cancer ScreeningCervical Cancer Screening

Keywords

Environmental barriers to cancer screeningPerson-level barriers to cancer screening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests

    10 weeks

Study Arms (2)

Self-Sampling Intervention

EXPERIMENTAL

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 testDiagnostic Test: Fecal occult blood test

Control

NO INTERVENTION

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.

Interventions

Self-sampling HPV testDIAGNOSTIC_TEST

Tests for human papillomavirus from cervical cell sample

Also known as: Evalyn® Brush
Self-Sampling Intervention
Fecal occult blood testDIAGNOSTIC_TEST

Tests for human hemoglobin from blood in fecal samples

Also known as: InSure® test
Self-Sampling Intervention

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Interventions

Occult Blood

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Limitations and Caveats

Low recruitment of minorities; Lack of sufficient power in statistical analyses; Use of cervical cancer screening methods unapproved by the FDA, Use of self-report for primary outcome.

Results Point of Contact

Title
Jennifer L. Moss, PhD
Organization
Pennsylvania State University College of Medicine
jmoss1@pennstatehealth.psu.edu
717-531-0003

Study Officials

  • Jennifer Moss, PhD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Family and Community Medicine / Department of Public Health Sciences

Study Record Dates

First Submitted

July 4, 2020

First Posted

July 15, 2020

Study Start

February 18, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

December 13, 2022

Results First Posted

October 18, 2022

Record last verified: 2022-11

Locations

US(1)