Telehealth & HPV Self-Collection

Gynecologic Cancer Clinical Trial

Official title:

Cervical Cancer Screening: Evaluation of Telehealth to Enhance HPV Self-Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089825
• Other study ID #: STUDY00023478
• Secondary ID: OHSU IRB 23478
• Status: Completed
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: January 19, 2023

Study information

• Verified date: August 2023
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: January 19, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Other:
• Receive 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.
• Telehealth-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.

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University, Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants preferring self-collection to provider collection	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.	Post-intervention: 2 weeks after receipt of test results
Secondary	Median perceived difficulty understanding self-collection instructions	In follow-up survey, participants will indicate how difficult the self-collection instructions were to understand, on a 10-point Likert scale.	Post-intervention: 2 weeks after receipt of test results
Secondary	Median discomfort level with self-collection	In follow-up survey, participants will indicate how much discomfort their experienced during self-collection, on a 10-point Likert scale.	Post-intervention: 2 weeks after receipt of test results