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Educational Video's Impact on Knowledge Regarding Cervical Cancer Screening

Primary Purpose

Human Papilloma Virus, Cervical Dysplasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational video
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus focused on measuring cervical cancer screening, pap smear, HPV vaccination

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Stephanie Wang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Video and physician counseling arm

Physician counseling arm

Arm Description

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.

This group will complete a pre survey and will then see their provider. Following provider visit patients will complete a post survey.

Outcomes

Primary Outcome Measures

Pre Knowledge score
Knowledge scores regarding cervical cancer screening and prevention. This will be scored as percentage correct out of 13 questions.
Post knowledge score
Knowledge scores regarding cervical cancer screening and prevention. This will be scored as percentage correct out of 13 questions.

Secondary Outcome Measures

Post Satisfaction scores
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

Full Information

First Posted
January 30, 2023
Last Updated
July 10, 2023
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT05756192
Brief Title
Educational Video's Impact on Knowledge Regarding Cervical Cancer Screening
Official Title
An Educational Video's Impact on Knowledge About HPV Vaccination and Cervical Cancer Screening Among Hispanic Patients: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus, Cervical Dysplasia
Keywords
cervical cancer screening, pap smear, HPV vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Care providers will be masked as we do not want bias to impact provider counseling at time of visit.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video and physician counseling arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Physician counseling arm
Arm Type
No Intervention
Arm Description
This group will complete a pre survey and will then see their provider. Following provider visit patients will complete a post survey.
Intervention Type
Other
Intervention Name(s)
Educational video
Intervention Description
Intervention is a 10-minute animated video that explains cervical cancer screening and prevention.
Primary Outcome Measure Information:
Title
Pre Knowledge score
Description
Knowledge scores regarding cervical cancer screening and prevention. This will be scored as percentage correct out of 13 questions.
Time Frame
Will be measured immediately before the appointment.
Title
Post knowledge score
Description
Knowledge scores regarding cervical cancer screening and prevention. This will be scored as percentage correct out of 13 questions.
Time Frame
Will be measured immediately after the appointment.
Secondary Outcome Measure Information:
Title
Post Satisfaction scores
Description
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
Time Frame
Will be measured immediatley after the provider visit and/or administration or video based educational tool (if randomized to the intervention line).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Stephanie Wang
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31234354
Citation
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.
Results Reference
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PubMed Identifier
21617785
Citation
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.
Results Reference
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PubMed Identifier
25693011
Citation
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.
Results Reference
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PubMed Identifier
20040833
Citation
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.
Results Reference
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PubMed Identifier
32282601
Citation
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.
Results Reference
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PubMed Identifier
28155005
Citation
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.
Results Reference
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PubMed Identifier
34571210
Citation
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.
Results Reference
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PubMed Identifier
29959929
Citation
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.
Results Reference
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Educational Video's Impact on Knowledge Regarding Cervical Cancer Screening

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