Educational Video's Impact on Knowledge Regarding Cervical Cancer Screening

Human Papilloma Virus Clinical Trial

Official title:

An Educational Video's Impact on Knowledge About HPV Vaccination and Cervical Cancer Screening Among Hispanic Patients: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05756192
• Other study ID #: NCR224166
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: July 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• Human Papilloma Virus
• Papilloma
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Other:
• Educational video
Intervention is a 10-minute animated video that explains cervical cancer screening and prevention.

Locations

Country	Name	City	State
United States	Stephanie Wang	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre Knowledge score	Knowledge scores regarding cervical cancer screening and prevention. This will be scored as percentage correct out of 13 questions.	Will be measured immediately before the appointment.
Primary	Post knowledge score	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	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	Will be measured immediatley after the provider visit and/or administration or video based educational tool (if randomized to the intervention line).