Gynecologic Cancer
Conditions
Keywords
Pap Smear, Human papillomavirus, Telehealth
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.
Interventions
OTHERReceive routine instructions
Study subjects randomized to this arm will receive a mailed myLab Box kit with instructions on HPV self-collection and postage to be shipped directly to the commercial lab. It should take less than 5 minutes to collect the sample.
OTHERTelehealth-based instructional visit and receive routine instructions
Study subjects randomized to this arm will similarly receive a mailed myLab Box kit and also undergo a brief 5-10 telehealth instructional visit via video conference.
Sponsors
Robert Wood Johnson Foundation
Oregon Health and Science University
OHSU Knight Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants preferring self-collection to provider collection | 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
| Measure | Time frame | Description |
|---|---|---|
| Median discomfort level with self-collection | Post-intervention: 2 weeks after receipt of test results | In follow-up survey, participants will indicate how much discomfort their experienced during self-collection, on a 10-point Likert scale. |
| Median perceived difficulty understanding self-collection instructions | Post-intervention: 2 weeks after receipt of test results | In follow-up survey, participants will indicate how difficult the self-collection instructions were to understand, on a 10-point Likert scale. |
Countries
United States
Outcome results
None listed