Relational Agents in Cervical Cancer Education (RACE)

NCT06537687 | Completed

• 1 other identifier: 2020-031
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervix Cancer; Human Papilloma Virus; Vaginal Cancer; Vulvar Cancer

Outcome Measures

Primary Outcomes (2)

• Participation Rate

  The Ratio of the number of participants to the number of patients asked to join the clinical trial

  Up to 6 weeks

• Survey Completion Rate

  The Ratio of the number of participants who complete the survey to the number of participants overall.

  Up to 6 Weeks

Secondary Outcomes (4)

• Change in intention to discuss HPV vaccination

  Up to 6 weeks

• Change in Health Literacy

  Up to 6 weeks

• Change in social norms and behaviors

  Up to 6 weeks

• Change in Stigma

  Up to 6 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

The control group will be given a standardized handout

Other: Control

Intervention

EXPERIMENTAL

The intervention group will be shown an educational video

Other: Intervention

Interventions

Control OTHER

A standardized handout on HPV and vaccine education will be given

Control

Intervention OTHER

A video about HPV and vaccines on a tablet provided by a research assistant

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radhika Gogoi: lead
• University of Oklahoma: collaborator

Study Sites (2)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Radhika Gogoi, M.D. PhD

  Karmanos Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: November 18, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 5, 2024

Record last verified: 2024-07

Locations

US (2)