- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05756192
Educational Video's Impact on Knowledge Regarding Cervical Cancer Screening
July 10, 2023 updated by: Stephanie Wang, George Washington University
An Educational Video's Impact on Knowledge About HPV Vaccination and Cervical Cancer Screening Among Hispanic Patients: a Randomized Control Trial
The researchers will be conducting a prospective randomized trial where the researchers will be introducing an educational video to see whether there is an increase in knowledge scores surrounding cervical cancer, cervical cancer screening, and prevention with HPV vaccinations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The researchers are conducting a single-blinded randomized controlled trial.
All patients who meet exclusion criteria will be recruited at the time of their visit where a Pap smear will be collected at an ob/gyn clinic.
If patients agree to participate in the study, they will be randomized into one of two arms.
A control arm or an interventional arm.
The control arm just includes physician counseling regarding cervical cancer screening/prevention, while the interventional arm includes patient's watching a video on cervical cancer screening/prevention as well as physician counseling.
Patient will be administered a survey before and after to assess knowledge and satisfaction scores.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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District of Columbia
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Washington, District of Columbia, United States, 20052
- Stephanie Wang
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female patient
- Hispanic patients
- Between age 21-65 y/o
- Receiving pap smear during clinic appointment
Exclusion Criteria:
- Non-female patients
- Non-Hispanic patients
- Age less than 21
- Age greater than 65
- not receiving pap smear
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video and physician counseling arm
This groups will complete a pre survey and will then watch the 10-minute educational video on cervical cancer screening and prevention prior to seeing their provider.
Patients will then see the provider and will complete a post survey following appointment.
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Intervention is a 10-minute animated video that explains cervical cancer screening and prevention.
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No Intervention: Physician counseling arm
This group will complete a pre survey and will then see their provider.
Following provider visit patients will complete a post survey.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre Knowledge score
Time Frame: Will be measured immediately before the appointment.
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Knowledge scores regarding cervical cancer screening and prevention.
This will be scored as percentage correct out of 13 questions.
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Will be measured immediately before the appointment.
|
Post knowledge score
Time Frame: Will be measured immediately after the appointment.
|
Knowledge scores regarding cervical cancer screening and prevention.
This will be scored as percentage correct out of 13 questions.
|
Will be measured immediately after the appointment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post Satisfaction scores
Time Frame: Will be measured immediatley after the provider visit and/or administration or video based educational tool (if randomized to the intervention line).
|
Satisfaction scores regarding intervention and appointment.
Satisfaction questions will be scored on Likert scale from 1-5 with 5 being most satisfied and 1being the least sat
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Will be measured immediatley after the provider visit and/or administration or video based educational tool (if randomized to the intervention line).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, Moreira ED Jr, Ngan Y, Petersen LK, Lazcano-Ponce E, Pitisuttithum P, Restrepo JA, Stuart G, Woelber L, Yang YC, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Chan IS, Chen J, Gesser R, Moeller E, Ritter M, Vuocolo S, Luxembourg A; Broad Spectrum HPV Vaccine Study. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015 Feb 19;372(8):711-23. doi: 10.1056/NEJMoa1405044.
- Gibb RK, Martens MG. The impact of liquid-based cytology in decreasing the incidence of cervical cancer. Rev Obstet Gynecol. 2011;4(Suppl 1):S2-S11.
- Rahman S, Kripalani S, Keegan E, Sparks A, Amdur R, Moawad G, Sheth S, Klebanoff J. An educational video's impact on the induction of labor experience: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100495. doi: 10.1016/j.ajogmf.2021.100495. Epub 2021 Sep 24.
- Olusola P, Banerjee HN, Philley JV, Dasgupta S. Human Papilloma Virus-Associated Cervical Cancer and Health Disparities. Cells. 2019 Jun 21;8(6):622. doi: 10.3390/cells8060622.
- Henk HJ, Insinga RP, Singhal PK, Darkow T. Incidence and costs of cervical intraepithelial neoplasia in a US commercially insured population. J Low Genit Tract Dis. 2010 Jan;14(1):29-36. doi: 10.1097/LGT.0b013e3181ac05e9.
- Lichter K, Krause D, Xu J, Tsai SHL, Hage C, Weston E, Eke A, Levinson K. Adjuvant Human Papillomavirus Vaccine to Reduce Recurrent Cervical Dysplasia in Unvaccinated Women: A Systematic Review and Meta-analysis. Obstet Gynecol. 2020 May;135(5):1070-1083. doi: 10.1097/AOG.0000000000003833. Erratum In: Obstet Gynecol. 2020 Jun;135(6):1489.
- Akinlotan M, Bolin JN, Helduser J, Ojinnaka C, Lichorad A, McClellan D. Cervical Cancer Screening Barriers and Risk Factor Knowledge Among Uninsured Women. J Community Health. 2017 Aug;42(4):770-778. doi: 10.1007/s10900-017-0316-9.
- Pallett AC, Nguyen BT, Klein NM, Phippen N, Miller CR, Barnett JC. A randomized controlled trial to determine whether a video presentation improves informed consent for hysterectomy. Am J Obstet Gynecol. 2018 Sep;219(3):277.e1-277.e7. doi: 10.1016/j.ajog.2018.06.016. Epub 2018 Jun 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Actual)
February 1, 2023
Study Completion (Actual)
February 1, 2023
Study Registration Dates
First Submitted
January 30, 2023
First Submitted That Met QC Criteria
February 23, 2023
First Posted (Actual)
March 6, 2023
Study Record Updates
Last Update Posted (Actual)
July 11, 2023
Last Update Submitted That Met QC Criteria
July 10, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Neoplasms, Squamous Cell
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Uterine Cervical Dysplasia
- Papilloma
Other Study ID Numbers
- NCR224166
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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