Cervix CancerRACENCT06537687
Relational Agents in Cervical Cancer Education (RACE)
A study testing Intervention in people with Cervix Cancer and Human Papilloma Virus, run by Radhika Gogoi at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Cancer, Human Papilloma Virus, Vaginal Cancer
- What is being tested?
- Intervention
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Nov 2020to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
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
- Being tested
- Control, Intervention
- Medical subject headings
- Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
A standardized handout on HPV and vaccine education will be given
InterventionOther
A video about HPV and vaccines on a tablet provided by a research assistant
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control group will be given a standardized handout Receives: Other: Control |
| Intervention | Experimental | The intervention group will be shown an educational video Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation Rate
The Ratio of the number of participants to the number of patients asked to join the clinical trial
Measured: Up to 6 weeks
Survey Completion Rate
The Ratio of the number of participants who complete the survey to the number of participants overall.
Measured: Up to 6 Weeks
Secondary outcomes (4)
Change in intention to discuss HPV vaccination
Changes from pre to post/follow up on intervention survey
Measured: Up to 6 weeks
Change in Health Literacy
Changes in knowledge of HPV virus and prevention from pre to post/follow up survey
Measured: Up to 6 weeks
Change in social norms and behaviors
Changes in social norms and behavioral control measures from pre and post/follow-up survey
Measured: Up to 6 weeks
Change in Stigma
Changes in stigma measures in pre and post/follow up surveys
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start18 Nov 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radhika Gogoi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Sponsor-investigator, Radhika Gogoi, Barbara Ann Karmanos Cancer Institute
- Investigators
- Radhika Gogoi, M.D. PhD, Principal investigator, Karmanos Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537687
- Sponsor's protocol ID
- 2020-031
- Acronym
- RACE
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relational Agents in Cervical Cancer Education (RACE)
- ClinicalTrials.gov ID
- NCT06537687
- Acronym / sponsor ID
- RACE / 2020-031
- Conditions
- Cervix Cancer, Human Papilloma Virus, Vaginal Cancer, Vulvar Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Radhika GogoiUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlThe control group will be given a standardized handout |
| Intervention | Experimental | Other: InterventionThe intervention group will be shown an educational video |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlA standardized handout on HPV and vaccine education will be given | Other | Control |
| InterventionA video about HPV and vaccines on a tablet provided by a research assistant | Other | Intervention |
Primary outcome
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
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.
4 secondary outcomes
Change in intention to discuss HPV vaccination
Time frame: Up to 6 weeks
Change in Health Literacy
Time frame: Up to 6 weeks
Change in social norms and behaviors
Time frame: Up to 6 weeks
Change in Stigma
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radhika Gogoi, M.D. PhD principal investigator
Karmanos Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Cervix Cancer and Human Papilloma Virus, run by Radhika Gogoi at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation Rate (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.