Cervical Cancer Screening: Evaluation of Telehealth to Enhance HPV Self-Collection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 131
- Locations
- 2
- Primary Endpoint
- Proportion of participants preferring self-collection to provider collection
Study Overview
Brief Summary
This study aims to compare the efficacy and participant experience of telehealth-based, self-collected cervical cancer screening to mail-based, self-collected cervical cancer screening across the adult female screening lifespan. This will be done by evaluating sufficient Human papillomavirus (HPV) sample collection and determining preference for self-collection verses provider collection, comparing role of telehealth in pre- and post- menopausal women's comfort with self-collection, comparing self-collection completion rates for women with and without telehealth visits.
Detailed Description
This will be a prospective, randomized study of women ages 25 and older, stratified by menopausal status (defined as 12 months or greater without menses or time at which both ovaries have been surgically removed), who are eligible for cervical cancer screening.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Individuals with a cervix who are eligible for primary HPV testing (age 25 and older) according to national cervical cancer screening guidelines.
- •Pregnant women are eligible for participation in this study as the collection process poses no threat to the woman or her fetus.
Exclusion Criteria
- •Individuals without a cervix
- •Have had prior pelvic radiation therapy or brachytherapy
- •Active or former diagnosis of ovarian, uterine, or cervical cancer unless determined eligible by PI upon further review of history and treatment
- •Individuals less than age 25 or no longer eligible/recommended to undergo cervical cancer screening
- •Adults who are unable to consent or are decisionally impaired
- •Individuals who are not English speaking
Outcomes
Primary Outcomes
Proportion of participants preferring self-collection to provider collection
Time Frame: Post-intervention: 2 weeks after receipt of test results
In follow-up survey, participants will indicate how the would prefer to have their next cervical cancer screening performed: by their healthcare provider or by self-testing.
Secondary Outcomes
- Median discomfort level with self-collection(Post-intervention: 2 weeks after receipt of test results)
- Median perceived difficulty understanding self-collection instructions(Post-intervention: 2 weeks after receipt of test results)
Investigators
Amanda Bruegl, MD
Clinical Instructor
OHSU Knight Cancer Institute