Cervical Cancer ScreeningNCT05762757
Patient-centered Educational Material to Improve Colposcopy Adherence
A study testing Colposcopy educational material in people with Cervical Cancer Screening, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The long-term goal is to develop, test, and disseminate a social needs navigator intervention that improves colposcopy adherence. Based on stakeholder feedback, this study addresses the need to include patient-centered educational material to the navigator program in order to improve patients' health literacy… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Colposcopy educational material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to 6 Sep 2024
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years or older
- Abnormal cervical screen confirmed by cytology or pathology
- Referred to Washington University School of Medicine (WUSM) colposcopy clinic
Who cannot join
- History of cervical cancer
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The long-term goal is to develop, test, and disseminate a social needs navigator intervention that improves colposcopy adherence. Based on stakeholder feedback, this study addresses the need to include patient-centered educational material to the navigator program in order to improve patients' health literacy regarding cervical cancer prevention.
Read the detailed description
The investigators will evaluate the effectiveness of the colposcopy educational material. The investigators aim to recruit 25 newly referred colposcopy patients before their appointment, ask them to take a 5-minute test about their knowledge of colposcopy, have them view an online demo of the educational resources, and then retake the test.
- Conditions
- Cervical Cancer Screening
- Being tested
- Colposcopy educational material
- Keywords
- cervical cancer screening, colposcopy, patient education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colposcopy educational materialOther
-Will consist of a handout featuring education and information regarding colposcopies.
| Study group | Role | What they receive |
|---|---|---|
| Colposcopy educational material | Experimental | Participants will complete a 9-question quiz that will assess knowledge of colposcopy. They will then view the colposcopy educational material and answer the same 9-question quiz to assess their knowledge of colposcopy. Participants will complete the Acceptability Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. Participants will also be asked whether the educational material influences their intention to adhere to colposcopy. Receives: Other: Colposcopy educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant knowledge of colposcopy
-9 question questionnaire that will assess patient knowledge of colposcopy
Measured: Prior to viewing educational material and after viewing educational material (Day 1)
Secondary outcomes (4)
Acceptability of educational material as measured by the Acceptability of Intervention Measure
This is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely disagree-completely agree). Mean score is calculated.
Measured: Day 1
Appropriateness of educational material as measured by the Intervention Appropriateness Measure
This is a 4-item measure of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely disagree-completely agree). Mean score is calculated.
Measured: Day 1
Feasibility of educational material as measured by the Feasibility of Intervention Measure
Measured: Day 1
Number of participants who stated that the educational material will influence their intention to adhere to colposcopy
This is a 4-item measure of perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely disagree-completely agree). Mean score is calculated.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start30 Jan 2024
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Obstetricians and Gynecologists
- Responsible party
- Sponsor
- Investigators
- Lindsay M Kuroki, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762757
- Sponsor's protocol ID
- 202208064
- Status last verified
- Sep 2024
- First submitted
- 20 Feb 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Educational Material to Improve Colposcopy Adherence
- ClinicalTrials.gov ID
- NCT05762757
- Acronym / sponsor ID
- 202208064
- Conditions
- Cervical Cancer Screening
- Keywords
- cervical cancer screening, colposcopy, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- American Association of Obstetricians and Gynecologists
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 10 Mar 2023 (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.
The long-term goal is to develop, test, and disseminate a social needs navigator intervention that improves colposcopy adherence. Based on stakeholder feedback, this study addresses the need to include patient-centered educational material to the navigator program in order to improve patients' health literacy regarding cervical cancer prevention.
Detailed description
The investigators will evaluate the effectiveness of the colposcopy educational material. The investigators aim to recruit 25 newly referred colposcopy patients before their appointment, ask them to take a 5-minute test about their knowledge of colposcopy, have them view an online demo of the educational resources, and then retake the test.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colposcopy educational material | Experimental | Other: Colposcopy educational materialParticipants will complete a 9-question quiz that will assess knowledge of colposcopy. They will then view the colposcopy educational material and answer the same 9-question quiz to assess their knowledge of colposcopy. Participants will complete the Acceptability Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. Participants will also be asked whether the educational material influences their intention to adhere to colposcopy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21 years or older
- Abnormal cervical screen confirmed by cytology or pathology
- Referred to Washington University School of Medicine (WUSM) colposcopy clinic
Key exclusion criteria (2 listed)
- History of cervical cancer
- Unable to consent
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 |
|---|---|---|
| Colposcopy educational material-Will consist of a handout featuring education and information regarding colposcopies. | Other | Colposcopy educational material |
Primary outcome
Change in participant knowledge of colposcopy
Time frame: Prior to viewing educational material and after viewing educational material (Day 1)
-9 question questionnaire that will assess patient knowledge of colposcopy
4 secondary outcomes
Acceptability of educational material as measured by the Acceptability of Intervention Measure
Time frame: Day 1
Appropriateness of educational material as measured by the Intervention Appropriateness Measure
Time frame: Day 1
Feasibility of educational material as measured by the Feasibility of Intervention Measure
Time frame: Day 1
Number of participants who stated that the educational material will influence their intention to adhere to colposcopy
Time frame: Day 1
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 19 Sep 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lindsay M Kuroki, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colposcopy educational material in people with Cervical Cancer Screening, run by Washington University School of Medicine 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 3 inclusion and 2 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 19 Sep 2024. 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?
Change in participant knowledge of colposcopy (time frame: Prior to viewing educational material and after viewing educational material (Day 1)). 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 19 Sep 2024.