Gynecologic CancerNCT05089825
Telehealth & HPV Self-Collection
A study testing Receive routine instructions and Telehealth-based instructional visit and receive routine instructions in people with Gynecologic Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Receive routine instructions and Telehealth-based instructional visit and receive routine instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 19 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Cervical Cancer Screening: Evaluation of Telehealth to Enhance HPV Self-Collection
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.
Read the 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.
- Conditions
- Gynecologic Cancer
- Being tested
- Receive routine instructions, Telehealth-based instructional visit and receive routine instructions
- Keywords
- Pap Smear, Human papillomavirus, Telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive routine instructionsOther
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 instructionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Receive routine instructions | Active comparator | Participants will receive routine instructions included in the myLAB Box Clinical Laboratory Improvement Amendments (CLIA) certified collection kit Receives: Other: Receive routine instructions |
| Telehealth Visit | Active comparator | Participants will have a telehealth-based instructional visit and receive routine instructions included in the myLAB Box commercially available, CLIA certified collection kit Receives: Other: Telehealth-based instructional visit and receive routine instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention: 2 weeks after receipt of test results
Secondary outcomes (2)
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.
Measured: Post-intervention: 2 weeks after receipt of test results
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.
Measured: Post-intervention: 2 weeks after receipt of test results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start19 Jan 2022
- Primary completion12 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Oregon Health and Science University
- Responsible party
- Principal investigator, Amanda Bruegl, MD, OHSU Knight Cancer Institute
- Investigators
- Amanda Bruegl, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089825
- Sponsor's protocol ID
- STUDY00023478
- Other IDs
- OHSU IRB 23478
- Status last verified
- Aug 2023
- First submitted
- 11 Oct 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cancer Screening: Evaluation of Telehealth to Enhance HPV Self-Collection
- ClinicalTrials.gov ID
- NCT05089825
- Acronym / sponsor ID
- STUDY00023478
- Conditions
- Gynecologic Cancer
- Keywords
- Pap Smear, Human papillomavirus, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Oregon Health and Science University
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive routine instructions | Active comparator | Other: Receive routine instructionsParticipants will receive routine instructions included in the myLAB Box Clinical Laboratory Improvement Amendments (CLIA) certified collection kit |
| Telehealth Visit | Active comparator | Other: Telehealth-based instructional visit and receive routine instructionsParticipants will have a telehealth-based instructional visit and receive routine instructions included in the myLAB Box commercially available, CLIA certified collection kit |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receive routine instructionsStudy 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. | Other | Receive routine instructions |
| Telehealth-based instructional visit and receive routine instructionsStudy 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. | Other | Telehealth Visit |
Primary outcome
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.
2 secondary outcomes
Median perceived difficulty understanding self-collection instructions
Time frame: Post-intervention: 2 weeks after receipt of test results
Median discomfort level with self-collection
Time frame: Post-intervention: 2 weeks after receipt of test results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Bruegl, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receive routine instructions and Telehealth-based instructional visit and receive routine instructions in people with Gynecologic Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants preferring self-collection to provider collection (time frame: Post-intervention: 2 weeks after receipt of test results). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.