Multilevel Intervention Based on Colorectal Cancer (CRC) and Cervical Cancer Self-screening in Rural, Segregated Areas
NCT ID: NCT04471194
Last Updated: 2022-12-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2021-02-18
2022-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Self-sampling HPV test
Tests for human papillomavirus from cervical cell sample
Fecal occult blood test
Tests for human hemoglobin from blood in fecal samples
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Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Self-sampling HPV test
Tests for human papillomavirus from cervical cell sample
Fecal occult blood test
Tests for human hemoglobin from blood in fecal samples
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* able to speak, read, and communicate well in English
* out of date for both cervical and colorectal cancer screening
Exclusion Criteria
* 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
50 Years
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Milton S. Hershey Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jennifer L. Moss, PhD
Assistant Professor, Department of Family and Community Medicine / Department of Public Health Sciences
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer Moss, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Penn State College of Medicine
Hershey, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00015480
Identifier Type: -
Identifier Source: org_study_id