Relational Agents in Cervical Cancer Education (RACE) (RACE)

July 31, 2024 updated by: Radhika Gogoi
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

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

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The intervention group will be shown an educational video
Other: Intervention
A video about HPV and vaccines on a tablet provided by a research assistant
Active Comparator: Control
The control group will be given a standardized handout
Other: Control
A standardized handout on HPV and vaccine education will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation Rate
Time Frame: Up to 6 weeks
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
Time Frame: Up to 6 Weeks
The Ratio of the number of participants who complete the survey to the number of participants overall.
Up to 6 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radhika Gogoi

Collaborators

University of Oklahoma

Investigators

  • Principal Investigator: Radhika Gogoi, M.D. PhD, Karmanos Cancer Center

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 18, 2020

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Estimated)

August 5, 2024

Study Record Updates

Last Update Posted (Estimated)

August 5, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-031

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.

Subscribe