Relational Agents in Cervical Cancer Education (RACE)

Not Applicable

Completed

• Conditions: Cervix Cancer; Human Papilloma Virus; Vaginal Cancer; Vulvar Cancer
• Interventions: Other: Control; Other: Intervention

• Registration Number: NCT06537687
• Lead Sponsor: Radhika Gogoi

Brief Summary

The goal of this clinical trial is to assess the feasibility of using interactive teaching to educate cervical cancer patients about Human papillomavirus (HPV) and HPV vaccinations.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

Inclusion Criteria

• Adults aged 18 and older
• Patients with an ICD9 diagnosis of cervical/vaginal/vulvar cancer or dysplasia receiving care at Karmanos Cancer Institute or OU Health Stephenson Cancer Center

Exclusion Criteria

• Patients who are recorded in the EHR as requesting to be removed from research
• Non-English speakers
• Any cognitive disability that prevents informed consent
• Any individual recruited in previous phases of the Study will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	The control group will be given a standardized handout
Intervention	Intervention	The intervention group will be shown an educational video

Primary Outcome Measures

Name	Time	Method
Participation Rate	Up to 6 weeks	The Ratio of the number of participants to the number of patients asked to join the clinical trial
Survey Completion Rate	Up to 6 Weeks	The Ratio of the number of participants who complete the survey to the number of participants overall.

Secondary Outcome Measures

Name	Time	Method
Change in intention to discuss HPV vaccination	Up to 6 weeks	Changes from pre to post/follow up on intervention survey
Change in social norms and behaviors	Up to 6 weeks	Changes in social norms and behavioral control measures from pre and post/follow-up survey
Change in Stigma	Up to 6 weeks	Changes in stigma measures in pre and post/follow up surveys
Change in Health Literacy	Up to 6 weeks	Changes in knowledge of HPV virus and prevention from pre to post/follow up survey

Trial Locations

Locations (2)

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States